Acceptance criteria: The specifications and acceptance/rejection criteria, such as acceptable quality

level and unacceptable quality level, with an associated sampling plan that are necessary for making a
decision to accept or reject a lot or batch of raw material, intermediate, packaging material, or active
pharmaceutical ingredient. This term can also be applied to validation.
Act: The Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).
Actual yield: The quantity that is actually produced at any appropriate phase of manufacture,
processing, or packing of a particular API or intermediate.
Active ingredient: Any component that is intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to effect the structure or
any function of the body of man or other animals. The term includes those components that may
undergo chemical change in the manufacture of the drug product and be present in the drug product in a
modified form intended to furnish the specified activity or effect.
Active Pharmaceutical Ingredient (API):
According to WHO Any substance or combination of substances used in a finished pharmaceutical
product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the
diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring,
correcting or modifying physiological functions in human beings."
In other word Any substance that is represented for use in a drug and that, when used in the
manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage
form of the drug. Such substances are intended to furnish pharmacological activity or other direct effect
in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and
function of the body of humans or other animals. APIs include substances manufactured by processes
such as (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods;
(4) isolation/recovery from natural sources; or (5) any combination of these processes.
Agency: The United States Food and Drug Administration (FDA).
Analytical methods validation: The process by which it is established, by laboratory studies, that the
performance characteristics of the method meet the requirements for the intended analytical
applications.
Approval: Once a countrys regulatory authority (for example, the Food and Drug Administration in the
United States) approves a new drug application, the new medicine becomes available for physicians to
prescribe. The manufacturing company must continue to submit periodic reports to the regulatory
authority, including any cases of adverse reactions and appropriate quality control records. For some
medicines, the regulatory authority may require additional studies to evaluate long-term effects.
Batch: A specific quantity of an intermediate or API intended to have uniform character and quality,
within specified limits, and produced according to a single manufacturing order during the same cycle of
manufacture. A batch may also mean a specific quantity of material or API processed in one process or
series of processes so that it could be expected to be homogenous.
Biologic active pharmaceutical ingredient: A material originating from a biological manufacturing
process intended to furnish pharmacological activity or other direct effect in the cure, treatment, or
prevention of disease or conditions of human beings.
Biologic product: Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the
prevention, treatment, or cure of diseases or conditions of human beings.
Brand-name drug: A drug that is sold under the unique, trademarked name selected by the
manufacturer rather than under its chemical name.

Calibration: The demonstration that a particular instrument or device produces results within specified
limits by comparison with those produced by a traceable standard over an appropriate range of
measurements.
Chemical reaction: A process that involves a chemical transformation of a starting material or
intermediate to form a new compound (e.g., bond formation, oxidation, reduction).
Cleaning agent: Any material used to clean process equipment, utensils, and storage vessels. These may
include soaps, detergents, surfactants, alkalis, acids, or other materials, such as organic solvents, if the
solvent is specifically used for cleaning and is not a solvent used in the next processing step.
CIP: Clean In Place is a method of cleaning installed pipe and equipment without having to dismantle or
move the pipe and equipment. However, provisions should be made for partial disassembly or for
personnel access for purposes of cleaning validation to facilitate inspection and sampling of inner
product surfaces for possible residue or contaminates.
Clinical: Denotes the symptoms and course of a disease as distinguished from the laboratory findings or
anatomical changes.
Clinical investigator: Experienced clinical researcher who implements a clinical study protocol with
patients.
Clinical pharmacologist: One who has undergone training in basic pharmacology of therapeutic agents
in the prevention, treatment and control of disease in man.
Clinical response: Any response by a patient to therapy. A positive response can be either complete, in
which all signs or symptoms of the disease improve or partial, in which at least one half of the signs or
symptoms of a disorder improve and no new signs appear.
Clinical trial or clinical study: Testing in which preventive, diagnostic, or therapeutic agents are given
to a human population under controlled conditions to determine the agents safety and effectiveness.
This systematic investigation tests the effects of materials or methods, according to a formal study plan
(that is, a protocol), usually in subjects having a particular disease or class of diseases. These trials are
conducted to satisfy the regulatory requirements to obtain marketing approval for a new drug or for a
new indication for a drug previously approved for marketing. In the United States, must be under an
approved investigational new drug application, under the guidance of an Institutional Review Board, and
in accordance with the Food and Drug Administrations (FDA) rules on human studies and informed
consent of participants. These studies are conducted in three phases: Phase I, Phase II and Phase III.
Commissioning: Commissioning can be subdivided into three major activities; installation, operation
and performance qualifications. It is a formal, written procedure to the planning, executing and
documenting of facility validation. This process may include environmental compliance checks,
verification of personnel protection equipment and qualification of containment systems as well as
validation of systems related to cGMP regulations.
Component: Any ingredient intended for use in the manufacture of a drug product, including those that
may not appear in such drug product.
Concurrent validation: A subset of prospective validation in which API batches are released for
distribution, based on extensive testing, before completion of process validation. Once data from
additional batches produced under replicated conditions show uniformity, the process may be considered
validated.

Containment: Achieving a level of control over a raw material, intermediate, or API that provides
proper protection of these materials from external contamination and cross-contamination.
Contamination: The introduction of impurities of a chemical or microbiological nature, or of foreign
matter, into or onto a raw material, intermediate, or API (e.g., occurring during production, sampling,
packaging or repackaging, storage or transport).
Continuous production: A process in which a material is continuously produced in a step or series of
steps. In a continuous process, the batches of raw materials and the process parameters can be
statistically, but not absolutely, correlated to the material produced in a given period of time.
Controlled study or controlled trial: Clinical testing in which one group of subjects is used as a
standard of comparison to determine the usefulness of a new medical approach. In a controlled study,
doctors give the new drug being tested to one group of subjects, called the "treatment group." They give
another drug, or no drug, to a second group of people under the same conditions. This group is often
called the "control group." Researchers then compare the results of the two groups.
Critical process parameters: Process parameters that must be controlled within established operating
ranges to ensure that the API or intermediate will meet specifications for quality and purity.
Critical process steps: Process steps that must be controlled within established operating ranges to
ensure that the API or intermediate will meet specifications for quality and purity.
Cross-contamination: A contamination of a material or product with another material or product.
Development report: A report that summarizes the major stages of API development from early stages
through large-scale manufacturing.
Dosage formulation: The form in which a drug is produced. Pharmaceutical companies use many
methods of drug delivery, including oils, gels, creams and sprays; capsules and tablets; injects; implants;
suppositories; and liquids and syrups.
Dosage strength: Amount of active drug contained in a particular formulation; for example 50, 100, or
500 milligrams.
Double-blind study: A scientific study in which neither the subject (patients) nor the investigators
(treating physicians) know who is receiving the experimental treatment and who is receiving a placebo
(a control or "sugar pill").
Drug: Articles that are recognized in the official United States Pharmacopeia, official Homeopathic
Pharmacopeia of the United States, or official National Formulary, or any supplement to them; (b)
articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans
or other animals; and articles (other than food) intended to affect the structure or any function of the
body of humans or other animals.
Medicine: Medicine is the applied science or practice of the diagnosis, treatment, and prevention
of disease. It encompasses a variety of health care practices evolved to maintain and restore health by
the preventionand treatment of illness in human beings.
Drug delivery: The process by which a formulated drug is administered to the patient. Traditional
methods have been orally or by injection. Newer methods include through the skin by application of a
transdermial patch, or across the nasal membrane by administration of a specially formulated nasal
spray.

Drug interaction: Modification of the effect of one drug by another in a way that diminishes, negates or
enhances the effectiveness or safety of one or both drugs.
Drug product: A finished dosage form, for example, a tablet, capsule or solution, that contains an active
pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients. The
term also includes a finished dosage form that does not contain an API but is intended to be used as a
placebo.
Efficacy: Measure of the therapeutic effectiveness of a drug.
Electropolishing: The electrochemical method of removing metal (usually stainless steel) from a
surface. More specifically, it is the anodic dissolution of metal in the presence of an electrolyte and an
imposed current potential. This process creates a continuous film of chromium rich oxide on the affected
surface. The resulting film provides the following benefits:
1. It provides an excellent passive barrier between the body of the material (i.e. internal or external
pipe wall) and the contained fluid, or external environment, enhancing corrosion resistance.
2. Provides for improved cleanability and sterilization aspects.
3. Allows for improved quality control by exposing defects in welds and base material.
4. Avoids the surface tension caused when mechanical polishing is used.
Eligibility criteria: Key facts about a persons health that make a patient right, or not right, for a certain
research study. Examples of these facts include: a persons age, what symptoms of the illness he or she
has, results of certain laboratory tests, a persons overall health, and past treatments. Both the "musthave" and the "cant-have" check lists help doctors get clear research results about whom a new drug
will help, not help, or harm.
Enantiomers: Compounds with the same molecular formula as the API, which differ in the spatial
arrangement of atoms within the molecule and are non-superimposable mirror images.
Ethical drug: A drug that primarily sold only through physicians and pharmacists, rather through direct
selling to customers. Sometimes referred to as a "prescription-only" drug.
Expected yield: The quantity of API or intermediate or the percentage of theoretical yield anticipated at
any appropriate phase of production based on data from process development or process validation.
Expiry/expiration date: The date (usually placed on the containers/labels of an API) designating the
time during which the API is expected to remain within established shelf-life specifications if stored
under defined conditions and alter which it should not be used.
Extraneous substance: An impurity arising from any source extraneous to the manufacturing process.
Fiber: Any particulate contaminant with a length at least three times greater than its width.
Gang-printed labeling: Labeling derived from a sheet of material on which more than one item of
labeling is printed.
Generic drug: A broad term for chemically equivalent drugs that are available from multiple
manufacturers. Commonly used to refer to products, other than then innovators, that are sold under the
universal chemical name for the drug.
GMP (cGMP): (current) Good Manufacturing Practice as put forth in various guidelines through the
combined efforts of the FDA, U.S. Department of Health and Human Services, Center for Drug
Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for
Veterinary Medicine (CVM). These guidelines, without providing specific methodology, identify the
expectations of the FDA in regard to the design, construction and operation of facilities intended for the
manufacturing, processing, packing or holding of APIs.

Grit:
In
reference
to
the
polishing
of
stainless
steel
pipe:
Grit is one method of determining or specifying a degree of smoothness or surface roughness required.
Initially a desired smoothness for the inside or outside of pipe was specified in polish numbers such as
#4 or #7. However, this system of specifying surface roughness provided for too broad a range of
roughness. Grit numbers have essentially replaced polish numbers in an effort at providing more specific
requirements. For example: a #4 polish could vary from an 80 grit to a 150 grit finish; a #7 polish could
vary from a 180 grit to a 320 grit finish. The industry is now adopting an even more specific method of
determining surface roughness. The surface is specified in micro inches or microns and measured with a
profilometer. The surface roughness is measured or specified as either of two arithmetic derivations:
Rq root mean square or Ra arithmetic mean. In utilizing a quantitative measuring technique, all of the
variables inherent in polishing are eliminated. An end user can now specify a specific surface roughness.
For example by specifying 25 m in Ra for a surface roughness the vendor now has to determine the best
way to achieve that very specific finish requirement.
Identified impurity: An impurity for which a structural characterization has been achieved.
Impurity: Any component of an API that is not the entity defined as the API.
Impurity profile: A description of the identified and unidentified impurities present in an API.
Inactive ingredient: Any component other than an "active ingredient".
Indications: Treatments that a drug will address. Approved indications are those that government
regulators have accepted based on clinical testing. Only these indications may be marketed and offered
for sale to the public, although physicians may prescribe drugs for unapproved indications according to
their professional judgment.
Informed consent: The process by which patients learn about and document their understanding of the
purpose and procedures of a clinical trial and their agreement to participate in that trial.
In-process controls: Testing and activities performed during production to monitor and, if necessary,
adjust the process.
In-process material: Any material manufactured, blended, or derived by chemical reaction that is
produced for, and used in, the preparation of an API.
Installation Qualification: Establishing confidence that process equipment and ancillary systems are
capable of consistently operating within established limits and tolerances.
Institutional Review Board (IRB): A group of doctors, science experts, clergy and others who review
and approve the performance of each clinical study at their institution. Each hospital doing the research
must have a review board. This board makes sure that the study protects patient safety in light of the
potential benefit that it may bring. IRB is the term used in the United States, but the committee is more
frequently referred to as an "ethics committee" in other markets.
Intermediate: A material produced during steps in the synthesis of an API that must undergo further
molecular change or processing before it becomes an API.
ISO: International Standards Organization
Investigational New Drug (IND) application: The document that a sponsor (usually a drug company)
must submit to the FDA before beginning testing of a new drug on humans. This IND application
contains the plans for the clinical for the clinical studies and gives a complete picture of the drug,
including its structural formula, animal test results, and manufacturing information. The IND application
contains information resulting from several years of research and testing.

In vitro: Latin phrase meaning "in glass". It refers to a process, test or procedure in which something is
measured, observed or produced outside a living organism after extraction from the organism. In vitro
studies are carried out in animals or humans.
In vivo: Latin phrase meaning "in the body". Referring to a biological process or experiment occurring
or carried out in the living organism. In vivo studies are carried in animals or humans.
Labeling: Printed materials that accompany a prescription drug when shipped in interstate commerce.
Ligand: An agent with a strong affinity to a metal ion.
Lot: A batch, or a specific identified portion of a batch having uniform character and quality within
specified limits. For an API produced by continuous process, it is a specific identified amount produced
in a unit of time or quantity in a manner that ensures its having uniform character and quality within
specified limits.
Lot number (control number, or batch number): Any distinctive combination of letters, numbers, or
symbols, or any combination of them, from which the complete history of the manufacture, processing,
packing, holding, and distribution of a batch or lot of an API or other material can be determined.
Manufacture, processing, packing, or holding: All operations used to manufacture an API to include
packaging and labeling operations, testing, and quality control of an API.
Mother liquor: The residual saturated liquid that remains after crystallization. A mother liquor may
contain unrecovered or unreacted starting materials, intermediates, the API and/or impurities.
New Drug Application (NDA): A formal application to the FDA for approval to market a new drug
product. When the investigational phase of a drug is completed, the manufacturer gathers together the
results of all studies and submits them to the FDA in a New Drug Application. This application is
reviewed in detail by a team of reviewers. The purpose of the NDA is to determine whether the drug
meets the statutory standards for safety, effectiveness, labeling and manufacturing.
New molecular entity: The designated therapeutic moiety (API) in a dosage form that has not been
approved for marketing in the United States (also referred to as a new chemical entity or new drug
substance). It may be a complex, simple ester, or salt of a previously approved API.
Non-fiber-releasing filter: Any filter which, after any appropriate treatment such as washing or
flushing, will not release fibers into the component or drug product that is being filtered. All filters
composed of asbestos are deemed to be fiber-releasing filters.
Operational Qualification: Operational Qualification (OQ) is the documented verification that the
identified system or subsystem performs as intended throughout all operating ranges of pressure and
temperature.
Over-the-counter drug (also OTC drug or nonprescription drug: Any drug that can be bought without a
prescription. Distribution of nonprescription drugs is unrestricted, and may be sold , for example, in
grocery stores and pharmacies.
Passivation: a process in which a diluted nitric acid solution is used to remove discoloration from weld
areas as well as dissolve and flush out all iron particulates and residue. These deposits may be the result
of being improperly cleaned and stored at the mill, the fab shop or the site. In the case of piping systems
the process involves circulating the heated nitric acid solution for a period of time followed by a
thorough flushing with potable or purified water. A test is then done to determine if free iron can be
detected. When the test determines that the system is clear of any contaminants potable or purified water
is flushed through the system until the pH and conductivity/resistivity of the effluent water samples are

the

same

as

that

of

the

influent.

Percentage of theoretical yield: The ratio of the actual yield (at any appropriate phase of the
manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same
phase),
stated
as
a
percentage.
Performance Qualification: Performance Qualification (PQ) provides documented evidence that the
integrated system or process is capable of consistently producing the intended product in a high quality
and
safe
manner.
Pharmaceutical: Referring to pharmacy or medical drugs; any therapeutic product used in medicine. A
pharmaceutical is a drug derived from organic or inorganic chemicals and used to treat a wide range of
medical
conditions.
Pharmaceutical Research and Manufacturers of America (PhRMA): Formerly known as PMA, this
is a nonprofit scientific and professional organization of more than 100 firms that discover, develop and
produce prescription drugs and biological products in the United States. The Associations members
produce most of the prescription drugs used in the United States and about half of the free worlds
supply
of
prescription
drugs.
Pharmacodynamics: The study of drug action primarily in terms of drug structure, site of action, and
the
biochemical
and
physiological
consequences
of
the
action.
Pharmacoeconomics: Studies focusing on the total impact of the product or services on the health
system. Pharmacoeconomics relies upon several economic methodologies, including cost-benefit, costeffectiveness
and
cost-utility
analysis.
Pharmacokinetics: The study of how the body handles a drug, with particular emphasis on the time
required for absorption, duration of action, distribution through the body and method of excretion.
Pharmacology: The science that deals with the study of drugs in all aspects, including drugs
mechanisms
of
action.
Phase I clinical trials: Small studies involving healthy volunteers to assess drug tolerability (safety),
metabolism, structure-activity relationships, and mechanism of action in humans.
Phase II clinical trials: Tests designed to determine, under controlled conditions, whether or not a drug
has therapeutic benefit (efficacy) with individuals having the target disease (patients) and document
eventual short-term side effects (adverse reactions) and risks associated with the drug.
Phase III clinical trials: Larger studies to gain confirmatory efficacy and safety data in a broad base of
patients. The compound is given to patients according to a protocol that reflects the way the compound
is expected to used when it is on the market. These expanded studies generally include hundreds of site
locations
and
involve
thousands
of
patients.
Phase IIIb clinical trials: Trials that come after the new drug application is filed, but before the product
is approved for marketing. The goal of these studies is to provide additional data for marketing support
and the ultimate product launch, including conducting country-specific studies to support local needs.
Phase IV human testing or post-marketing surveillance: Tests conducted after marketing to obtain
additional data regarding product safety and efficacy over the life of a drug. The pharmaceutical is on
the
market
and
generating
revenue
during
this
period.
Physical manipulation: A process other than a chemical reaction that may change the purity or the
physical properties of the material, including but not limited to crystallization, recrystallization, gel

filtration,

chromatography,

milling,

drying,

or

blending.

Pilot scale: The manufacture of an API on a reduced scale by processes representative of and simulating
those
to
be
applied
on
a
larger
commercial
manufacturing
scale.
Placebo: Inactive agent without therapeutic value used in controlled studies to determine the efficacy of
the potential therapeutic agent against which it is being compared. The placebo is made to look exactly
like
the
therapeutic
agent.
Polishing (As
it
pertains
to
sanitary
stainless
steel
piping):
The process of resolving the roughness of the outside and/or the inside wall of stainless steel pipe by one
of two methods:
1. grit polishing a manual method of using an abrasive pad (sandpaper) with varying,
specified degrees of fineness to achieve a specified degree of smoothness.
2. electropolish an electrochemical method of removing metal from a surface.
(For further definition regarding surface roughness, grit determination and their
correlation see "grit".)
Polymorphism:

The

occurrence

of

different

crystalline

forms

of

the

same

API.

Potential impurity: An impurity that, from theoretical considerations, may arise from or during
manufacture.
It
may
or
may
not
actually
appear
in
the
API.
Preclinical research: Group of studies that test a drug on animals and other nonhuman test systems.
This testing is conducted to gain more data about the pharmaceuticals efficacy and safety before tests
on
humans
can
begin.
Primacy reference standard: A particular portion, lot or batch of an API or intermediate that has been
shown by an extensive set of analytical tests to be of the highest purity. This standard may be purchased
from a recognized source or may be prepared by independent synthesis or by further purification of
existing
production
material.
Process performance qualification: Establishing confidence that the process is effective and
reproducible.
Process validation: Establishing documented evidence that provides a high degree of assurance that a
specific process will consistently produce a product meeting its predetermined specifications and quality
characteristics.
Product performance qualification: Establishing confidence through appropriate testing that the
finished product produced by a specified process meets all release requirements for functionality and
safety.
Prophylactic treatment: Preventative treatment or precautions to avoid disease; treatment intended to
preserve
health
and
prevent
the
spread
of
disease.
Proprietary medicines: Over-the-counter (nonprescription) medicines sold under a trademark and
advertised
to
the
general
public.
Prospective validation: Establishing documented evidence that a system does what it purports to do
prior to the commercial distribution of a new API or an existing API made by a new or modified
process.

Protocol: Written documentation establishing strict and detailed guidelines and requirements for the
proper execution of an activity designed to verify the proper installation or operation of a specific
component,
segment
or
system
of
a
new
or
existing
facility.
Purification procedure: A process, such as crystallization, distillation, or chromatography, intended to
improve the purity of an API or intermediate.
Qualification: The action of proving that any equipment or process works correctly and consistently and
produces the expected results. Qualification is part of, but not limited to, a validation process, i.e.,
installation qualification (1Q), operation qualification (OQ), and performance qualification (PQ).
Qualification Protocol: A Qualification Protocol (QP) is a written plan or procedure stating in
sufficient detail how qualification will be achieved. Included are specific qualification requirements for
each equipment item, each system requirement, and product requirement. Each protocol should stipulate
test parameters as well as decision points on what constitutes acceptable test results. The written
protocols should be based on the associated qualification procedures and should be step-by-step
instructions to be used in the field to qualify equipment, instruments, materials, systems and subsystems,
and
should
include
data
sheets
to
record
critical
data.
Quality Assurance (QA): The sum total of the organized activities performed with the intent to ensure
that
all
APIs
are
of
the
quality
required
for
their
intended
use.
Quality Control (QC) Unit: Any person or organizational element designated by the firm to be
responsible
for
the
duties
relating
to
quality
control.
Quarantine: The status of materials isolated physically or by other effective means pending a decision
on their subsequent use.
Ra (CLA): arithmetic mean roughness value. The arithmetical average of all absolute distances of the
roughness profile R from the center line within the measuring length lm.
Rq (RMS): root mean square roughness value. (An alternative to Ra.) The RMS value of a profile
calculated over a single sampling length, but can be expressed as the mean result of 5 consecutive
sampling
lengths.
Range for critical process parameter: The range for each process parameter generally developed on
laboratory-, pilot-, or plant-scale batches that encompasses values that are capable of producing
intermediates
and
APIs
having
acceptable
quality
attributes.
Raw material: Any ingredient intended for use in the production of APIs. These may include starting
materials,
process
aids,
solvents,
and
reagents.
Reagent: A substance, other than a starting material or solvent, that is used in the manufacture of an API
or
intermediate.
Recovery: Any treatment of materials by a process intended to make them suitable for further use.
Repeating a chemical reaction: Adding fresh reagents or solvents to unreacted or base material and
repeating a chemical reaction from its beginning. This excludes those situations where a chemical
reaction is continued or extended in the same vessel with the addition of more solvent, to ensure
completion of a reaction or increase the yield and/or purity of the API (e.g., continuation of a
hydrogenation
step).
Representative sample: A sample that consists of a number of units that are drawn based on rational
criteria such as random sampling and intended to assure that the sample accurately portrays the material

being

sampled.

Reprocessing: Introducing an intermediate or API that does not conform to standards or specifications,
back into the process and repeating one or more steps that are part of the established manufacturing
process
(e.g.,
recrystallization
using
the
same
solvent).
Retest date: The date when the API should be re-examined to ensure that it is still suitable for use.
Retest period: The period of time during which the API can be considered to remain within
specifications, and therefore acceptable for use in the manufacture of a given drug product, provided that
it has been stored under defined conditions. After this period, the API should be retested for compliance
with
specifications
before
use.
Retrospective concurrent drug use evaluation: One of three forms of evaluation of prescribing
patterns to specifically determine the appropriateness of drug therapy. Retrospective drug use evaluation
is conducted after the therapy has been completed. There are two other forms of drug use evaluation:
concurrent (during the course of drug therapy) and prospective (before or at the time of despensing).
Retrospective validation: Establishing documented evidence that a system does what it purports to do
based on a review and analysis of historic information. It is normally conducted on an API already being
commercially distributed and is based on accumulated production, testing, and control data.
Reworking: Subjecting an intermediate or API that does not conform to standards or specifications, to
one or more processing steps that are different from the established manufacturing process (e.g.,
recrystallizing
with
a
different
solvent).
Risk-benefit ratio: Relation between the risks and benefits of a given treatment or procedure.
Institutional review boards located where the study is to take place determine whether the risks in a
study are reasonable with respect to the potential benefits. The patient also decides if it is reasonable, in
light
of
the
risk-benefit
ratio,
to
take
part
in
the
study.
Rx: An abbreviation of the Latin word "recipere" which means "to take". The symbol is used at the
beginning of a medical prescription.
Side effect: Secondary and usually adverse effect, as from a drug or other treatment. For example,
nausea
is
a
side
effect
of
some
anticancer
drugs.
Single-blind study: A study in which one party (either the patient or investigator) is unaware of what
medication
the
patient
is
taking.
Solvent: Any liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of
an
API
or
intermediate.
Starting material: A material used in the synthesis of an API, which is incorporated as an element into
the structure of an intermediate and/or of the API. Starting materials are normally commercially
available
and
of
defined
chemical
and
physical
properties
and
structure.
Strength: (i) The concentration of the drug substance ( for example, weight/weight, weight/volume, or
unit dose/volume basis) and/or, (ii) The potency, that is, the therapeutic activity of the drug product as
indicated by appropriate laboratory tests or by adequately developed and controlled clinical data
(expressed,
for
example,
in
terms
of
units
by
reference
to
a
standard).
Study arm: Patients in clinical trials are assigne to one part or segment of a study a study "arm". One
arm receives a different treatment from another.

System Qualification: System Qualification (SQ) consists of the IQ/OQ documentation pertaining to all
equipment, instruments, materials and subsystems within a specific system or unit operation, generally
identified by a single Piping & Instrument Flow Diagram (P&ID).
Therapeutic category: Group of drugs intended to treat or cure a particular disease or related diseases.
Several of these categories are antibiotics (drugs that prevent, inhibit or destroy microorganisms),
cardiovascular (drugs that treat diseases of the heart and blood vessels), hypnotics (drugs that induce
sleep),
and
nonsteroidal
anti-inflammatory
drugs
or
NSAIDs
Theoretical yield: The quantity that would be produced at any appropriate phase of manufacture,
processing, or packing of a particular API or intermediate, based upon the quantity of components to be
used,
in
the
absence
of
any
loss
or
error
in
actual
production.
Toxic

impurity:

Impurities

having

significant

undesirable

biological

activity.

Toxicology: Scientific discipline concerning the identification and effects of poisons and the treatment
of poisoned individual.
Toxicology safety and testing: Group of tests to determine the potential risk of a compound to man and
the environment. These studies involve the use of animals, tissue cultures and other test systems to
examine dose level, frequency of administration, and duration on the dose-response pattern of the
compound and its toxic side effects. Most toxicology and safety testing is conducted before its human
introduction.
TRx: A measure of total prescriptions (new and refills) issued in a given time period.
Unidentified impurity: An impurity that is defined solely by qualitative analytical properties (e.g.,
chromatographic retention time).
Validation: The procedure for establishing documented evidence that a specific system or facility is
constructed and operates according to a predetermined set of specifications and guidelines.
Validation protocol: A written plan stating how validation will be conducted while identifying specific
acceptance criteria. For example, the protocol for a typical manufacturing process identifies processing
equipment, critical process parameters/operating ranges, product characteristics, sampling and test data
to be collected, number of validation runs, and acceptable test results.
Working standard: An API, intermediate or other substance of established quality and purity, as shown
by comparison to a primary reference standard, used as a reference for routine laboratory analysis.

Refractive Index :In optics the refractive index or index of refraction n of a substance (optical medium)
is a dimensionless number that describes how light, or any other radiation, propagates through that
medium. It is defined as
,
where c is the speed of light in vacuum and v is the speed of light in the substance. For example, the
refractive index of water is 1.33, meaning that light travels 1.33 times as fast in vacuum as it does in
water.
Density: The mass density or density of a material is its mass per unit volume. The symbol most often
used for density is (the lower case Greek letter rho). Mathematically, density is defined as mass
divided by volume:

where is the density, m is the mass, and V is the volume. In some cases (for instance, in the United
States oil and gas industry), density is also defined as its weight perunit volume,[2] although this quantity
is more properly called specific weight.
Polarity: In chemistry, polarity refers to a separation of electric charge leading to a molecule or
its chemical groups having an electric dipole or multipolemoment. Polar molecules interact through
dipoledipole intermolecular forces and hydrogen bonds. Molecular polarity is dependent on the
difference in electronegativity between atoms in a compound and theasymmetry of the compound's
structure. Polarity underlies a number of physical properties including surface tension, solubility, and
melting- and boiling-points.
Viscosity: The viscosity of a fluid is a measure of its resistance to gradual deformation by shear
stress or tensile stress. For liquids, it corresponds to the informal notion of "thickness". For
example,honey has a higher viscosity than water.[1]
Viscosity is due to friction between neighboring parcels of the fluid that are moving at
different velocities. When fluid is forced through a tube, the fluid generally moves faster near the axis
and very slowly near the walls, therefore some stress (such as a pressure difference between the two
ends of the tube) is needed to overcome the friction between layers and keep the fluid moving. For the
same velocity pattern, the stress required is proportional to the fluid's viscosity. A liquid's viscosity
depends on the size and shape of its particles and the attractions between the particles.
Osmosis: Osmosis is the spontaneous net movement of solvent molecules through a
partially permeable membrane into a region of higher solute concentration, in the direction that tends to
equalize the solute concentrations on the two sides. It may also be used to describe a physical process in
which any solvent moves, without input of energy, across a semipermeable membrane (permeable to
the solvent, but not the solute) separating two solutions of different concentrations. Although osmosis
does not require input of energy, it does use kinetic energy and can be made to do work.
The osmotic pressure is defined to be the pressure required to maintain an equilibrium, with no net
movement of solvent. Osmotic pressure is a colligative property, meaning that the osmotic pressure
depends on the molar concentration of the solute but not on its identity.
Diffusion:The passive movement of molecules or particles
from regions of higher to regions of lower concentration.

along

a concentration gradient,

or

Dissolution: Dissolution is the process by which a solute forms a solution in a solvent. The solute, in the
case of solids, has its crystalline structure disintegrated as separate ions, atoms, and molecules form. For
liquids and gases, the molecules must be adaptable with those of the solvent for a solution to form.
Solubility:
Solubility is
the
property
of
a solid, liquid,
or gaseous chemical
substance called solute to dissolve in
a solid, liquid,
or gaseous solvent to
form
a
homogeneous solution of the solute in the solvent. The solubility of a substance fundamentally depends
on the physical and chemical properties of the used solute and solvent as well as on temperature,
pressure and the pH of the solution.
Disintegration: This test determines whether tablets and capsules disintegrate within a prescribed time
when placed in an immersion fluid under prescribed experimental conditions. Disintegration is defined
as the state in which no residue of the tablet or capsule, except fragments of undissolved coating or
capsule shell, remains on the screen of the test apparatus or, if any other residue remains, it consists of a
soft mass having no palpably firm, unmoistened core.
Friability: Friability testing is a laboratory technique used by the pharmaceutical industry to test the
likelihood of a tablet breaking into smaller pieces during transit. It involves repeatedly dropping a
sample of tablets over a fixed time, using a rotating wheel with a baffle, and afterwards checking

whether any tablets are broken, and what percentage of the initial mass of the tablets has been chipped
off. A typical specification will allow a certain percentage to be lost by chipping, and will not allow any
broken tablets.
Loss on Drying: The Loss on Drying Test is designed to measure the amount of water and volatile
matters in a sample when the sample is dried under specified conditions.
Definition of Karl Fischer Reagent:A colored solution of pyridine, sulfur dioxide, iodine, and
anhydrous methanol that reacts quantitatively with water to form a colorless solution and is used to
determine the amount of water in numerous substances.
K-F titration involves two reactions:
In the first reaction, an alcohol (usually methanol or ethanol), sulfur dioxide (SO2) and a base (RN) react
to form an alkylsulfite intermediate:
CH3OH + SO2 + RN [RNH]SO3CH3
In the second reaction, the alkylsulfite reacts with iodine (I2) and the water from the sample:
[RNH]SO3CH3 + I2 + H2O + 2RN

[RNH]SO4CH3 + 2[RNH]I

Since water and I2 are consumed in equimolar amounts in 2nd reaction, if you know the amount of I2
consumed, you know the amount of water that was present in the sample.

Titration: A technique to determine the concentration of a substance in solution by adding to it a

standard reagent of known concentration in carefully measured amounts until a reaction of definite and
known proportion is completed, as shown by a color change or by electrical measurement, and then
calculating the unknown concentration.
Direct Titration
A direct addition of standard titrant to the analyte (in stepwise way) in the presence of acid-base indictor
till the reaction is complete and reaching the E.P ( color change of the indicator)
Back Titration: A back titration is similar to a direct titration, but a bit more difficult. When an end
point is not easily identified due to no colour change, an excess volume of a reactant of known
concentration is added to the reactant of unknown concentration. Then the resulting mixture is titrated
again (or titrated back) to find the volume of the unreacted reactant, which will tell us the amount that
did react with the solution of unknown concentration. You need to take into account the amount of
excess reactant originally added.
Nonaqueous
titration:
Nonaqueous
titration
is
the titration of
substances
dissolvedin nonaqueous solvents. It is the most common titrimetric procedure used
in pharmacopoeial assays and serves a double purpose: it is suitable for the titration of very
weak acids and very weak bases, and it provides a solvent in which organic compounds are soluble. The
most commonly used procedure is the titration of organic bases with perchloric acid in anhydrous acetic
acid.
Complexometric titration:Complexometric titration (sometimes chelatometry) is a form of volumetric
analysis in which the formation of a colored complex is used to indicate the end point of a titration.
Complexometric titrations are particularly useful for the determination of a mixture of different metal
ions in solution. An indicator capable of producing an unambiguous color change is usually used to
detect the end-point of the titration.

Some Indicator

Methyl Red

Phenolphthalein
Universal indicator components
Indicator

Low pH
color

Transition pH
range

High pH
color

Thymol blue (first transition)

Red

1.2 2.8

Yellow

Methyl red

Red

4.4 6.2

Yellow

Bromothymol blue

Yellow

6.0 7.6

Blue

Thymol blue (second transition)

Yellow

8.0 9.6

Blue

Phenolphthalein

Colorless

8.3 10.0

Fuchsia

Absorbance: Absorbance is a quantitative measure expressed as a logarithmic ratio between the

radiation falling upon a material and the radiation transmitted through a material.
,
where
is the absorbance at a certain wavelength of light ( ), is the intensity of the radiation
(light) that has passed through the material (transmitted radiation), and
is the intensity of the radiation
before it passes through the material (incident radiation).
Adsorption: Adsorption is the adhesion of atoms, ions, or molecules from a gas, liquid, or dissolved
solid to a surface. This process creates a film of the adsorbateon the surface of the adsorbent. This
process differs from absorption, in which a fluid (the absorbate) permeates or is dissolved by a liquid or
solid (theabsorbent).
Beer-Lambert Law
Introduction:The Beer-Lambert law (also called the Beer-Lambert-Bouguer law or simply Beer's law)
is the linear relationship between absorbance and concentration of an absorber of electromagnetic
radiation. The general Beer-Lambert law is usually written as:
where A is the measured absorbance, a is a wavelength-dependent absorptivity coefficient, b is the
path length, and c is the analyte concentration. When working in concentration units of molarity, the
Beer-Lambert law is written as:
where
is the wavelength-dependent molar absorptivity coefficient with units of M-1 cm-1. The
subscript is often dropped with the understanding that a value for is for a specific wavelength. If

multiple species that absorb light at a given wavelength are present in a sample, the total absorbance at
that wavelength is the sum due to all absorbers:

where the subscripts refer to the molar absorptivity and concentration of the different absorbing species
that are present.
Limitations of the Beer-Lambert law
The linearity of the Beer-Lambert law is limited by chemical and instrumental factors. Causes of
nonlinearity include:
deviations in absorptivity coefficients at high concentrations (>0.01M) due to electrostatic
interactions between molecules in close proximity
scattering of light due to particulates in the sample
fluoresecence or phosphorescence of the sample
changes in refractive index at high analyte concentration
shifts in chemical equilibria as a function of concentration
non-monochromatic radiation, deviations can be minimized by using a relatively flat part of the
absorption spectrum such as the maximum of an absorption band
stray light
Prerequisites
There are at least six conditions that need to be fulfilled in order for Beers law to be valid. These are:
1. The absorbers must act independently of each other;
2. The absorbing medium must be homogeneous in the interaction volume
3. The absorbing medium must not scatter the radiation no turbidity;
4. The incident radiation must consist of parallel rays, each traversing the same length in the
absorbing medium;
5. The incident radiation should preferably be monochromatic, or have at least a width that is
narrower than that of the absorbing transition; and
6. The incident flux must not influence the atoms or molecules; it should only act as a non-invasive
probe of the species under study. In particular, this implies that the light should not cause optical
saturation or optical pumping, since such effects will deplete the lower level and possibly give
rise to stimulated emission.
If any of these conditions are not fulfilled, there will be deviations from Beers law.
Transmittance: Transmittance is the fraction of incident light (electromagnetic radiation) at a
specified wavelength that passes through a sample. The terms visible transmittance (VT) and visible
absorptance (VA), which are the respective fractions for the spectrum of light visible radiation, are also
used. The natural radiation of the cuvette corresponding to the temperature of the cuvette remains
ignored - see radiative transfer equation.
In equation form,

where
is the intensity of the incident radiation and I is the intensity of the radiation coming out of the
sample and
and
are transmittance and absorptance respectively. In these equations, scattering
and reflection are considered to be close to zero or otherwise accounted for. The transmittance of a
sample is sometimes given as a percentage.

Melting Point: The melting point (or, rarely, liquefaction point) of a solid is the temperature at which it
changes state from solidto liquid at atmospheric pressure. At the melting point the solid and liquid phase
exist in equilibrium. The melting point of a substance depends (usually slightly) on pressure and is
usually specified at standard pressure.
Boiling Point: The boiling point of a substance is the temperature at which thevapor pressure of
the liquid equals the pressure surrounding the liquid[1][2] and the liquid changes into a vapor.
Freezing Point: Liquids have a characteristic temperature at which they turn into solids, known as their
freezing point. In theory, the melting point of a solid should be the same as the freezing point of the
liquid. In practice, small differences between these quantities can be observed.
Critical Point: A critical point, also known as a critical state, occurs under conditions (such as specific
values of temperature, pressure or composition) at which no phase boundaries exist.
Critical temperature: The critical temperature of a substance is the temperature at and above which
vapor of the substance cannot be liquefied, no matter how much pressure is applied.
Critical Pressure:The critical pressure of a substance is the pressure required to liquefy a gas at its
critical temperature.
Colligative properties: Colligative properties are those properties of solutions that depend on the
number of dissolved particles in solution, but not on the identities of the solutes. For example, the
freezing point of salt water is lower than that of pure water, due to the presence of the salt dissolved in
the water.
Physical properties can be divided into two categories. Extensive properties (such as mass and volume)
depend on the size of the sample. Intensive properties (such as density and concentration) are
characteristic properties of the substance; they do not depend on the size of the sample being studied.
Vapour: A vapor (U.S spelling) or vapour (British spelling) is a substance in the gasphase at
a temperature lower than its critical point.[1] This means that the vapor can be condensed to a liquid or to
a solid by increasing its pressure without reducing the temperature.
Moisture: Moisture refers to the presence of a liquid, especially water, often in trace amounts. Small
amounts of water may be found.
Humidity: Humidity is the amount of water vapor in the air. Water vapor is the gas phase of water and
is invisible.[1] Humidity indicates the likelihood of precipitation,dew, or fog. Higher humidity reduces
the effectiveness of sweating in cooling the body by reducing the rate of evaporation of moisture from
the skin. This effect is calculated in a heat index table, used during summer weather.
There are three main measurements of humidity: absolute, relative and specific.Absolute humidity is
the water content of air.[2] Relative humidity, expressed as a percent, measures the current absolute
humidity relative to the maximum for that temperature. Specific humidity is a ratio of the water vapor
content of the mixture to the total air content on a mass basis.
Potentiometric titrations involve the measurement of the potential difference between two electrodes
of a suitable cell; conductometric titrations, the electrical conductance or resistance of the solution
being titrated; and amperometric titrations, the electric current passing during the course of the
titration. In the titrations just mentioned the end point is indicated by a marked change in the electrical
quantity that is being measured.
Ionic conduction :Ionic conduction (denoted by -lambda) is the movement of an ion from one site to
another through defects in thecrystal lattice of a solid or aqueous solution. Ionic conduction is one aspect
of current.[1] In solids, ions typically occupy fixed positions in the crystal lattice and do not move.
However, ionic conduction can occur, especially, as the temperature increases.

Optical rotation (optical activity) is the turning of the plane of linearly polarized light about the
direction of motion as the light travels through certain materials. It occurs in solutions
of chiral molecules such as sucrose (sugar), solids with rotated crystal planes such as quartz, and spinpolarized gases of atoms or molecules. It is used in the sugarindustry to measure syrup concentration,
in optics to manipulate polarization, in chemistry to characterize substances in solution, and in optical
mineralogy to help identify certain minerals in thin sections. It is being developed as a method to
measure blood sugar concentration in diabetic people.
Specific rotation :In stereochemistry, the specific rotation of a chemical compound [] is defined as
the observed angle of optical rotation when plane-polarized light is passed through a sample with a
path length of 1 decimeter and a sample concentration of 1 gram per 1 millilitre.
It is the main property used to quantify the chirality of a molecular species or a mineral. The specific
rotation of a pure material is an intrinsic property of that material at a given wavelength and
temperature. Values should always be accompanied by the temperature at which the measurement was
performed and the solvent in which the material was dissolved. Often the temperature is not specified; in
these cases it is assumed to be room temperature. The formal unit for specific rotation values is deg
dm1cm3 g1 but scientific literature uses justdegrees.[1]
A negative value means levorotatory rotation and a positive value means dextrorotatory rotation.
Dextrorotatory means that the plane of polarization is turned clockwise when the light comes through
the sample to the observer.
Optical rotation is measured with an instrument called a polarimeter. There is a linear relationship
between the observed rotation and the concentration of optically active compound in the sample. There
is a nonlinear relationship between the observed rotation and the wavelength of light used. Specific
rotation is calculated using either of two equations, depending on whether the sample is a pure chemical
to be tested or that chemical dissolved in solution.
For pure liquids

In this equation, l is the path length in decimeters, and (Greek letter "rho") is the density of the liquid
in g/mL, for a sample at a temperature T (given in degrees Celsius) and wavelength (in nanometers). If
the wavelength of the light used is 589 nanometer (the sodium D line), the symbol D is used. The sign
of the rotation (+ or ) is always given.

For solutions

In this equation, l is the path length in decimeters and c is the concentration in g/mL, for a sample at a
temperature T(given in degrees Celsius) and wavelength (in nanometers).[1] If the wavelength of the
light used is 589 nanometer(the sodium D line), the symbol D is used. The sign of the rotation (+ or )
is always given. When using this equation, the concentration and the solvent may be provided in
parentheses after the rotation. The rotation is reported using degrees, and no units of concentration are
given (it is assumed to be g/100mL).For example:
(c 1.0, EtOH)
Specific Conductance (SC) is a measure of how well water can conduct an electrical current.
Conductivity increases with increasing amount and mobility of ions. These ions, which come from the
breakdown of compounds, conduct electricity because they are negatively or positively charged when
dissolved in water. Therefore, SC is an indirect measure of the presence of dissolved solids such as

chloride, nitrate, sulfate, phosphate, sodium, magnesium, calcium, and iron, and can be used as an
indicator of water pollution.
Soft acids: The acceptor atoms are larger, have lower positive charge, have unshared pair of electrons in
their valence shell. Also they have higher polarisability and lower electronegativity.
Soft bases: The donor atoms are smaller, have higher positive charge, donot have unshared pair of
electrons in their valence shell. Also they have higher polarisability and lower electronegativity. They
are easily oxidised and the valence electrons are loosely held.
Hard acids: The acceptor atoms are smaller in size, have higher positive charge, no unshared pair of
electrons in their valence shell. Also they have lower polarisability and higher electronegativity.
Hard bases: The donor atoms have higher electronegativity, lower polarisability, difficult to oxidise.
The valence electrons are held tightly.
Absolute Hardness: The average of the difference between the ionisation energy and electron affinity is
termed as Absolute Hardness ()
= (I-A) / 2
The reciprocal of is termed as Absolute Softness ()
Some examples:
Hard Bases: OH-, F- , NH3
Soft Bases: I-, R3P, CN-, CO
Borderline Acids: Zn2+, Cu2+, Fe2+
Borderline Bases: Br-, N3-, NO2-, ArNH2
Hard Acids: H+, Li+, Mg+, BF3, AlCl3
Soft Acids: Cu+, Ag+, Hg2+, I2
Tonicity :Tonicity is a measure of the osmotic pressure gradient (as defined by the water potential of the
two solutions) of two solutions separated by a semipermeable membrane. It is commonly used when
describing the response of cells immersed in an external solution. Like osmotic pressure, tonicity is
influenced only by solutes that cannot cross the membrane, as only these exert an osmotic pressure.
Solutes able to freely cross the membrane do not affect tonicity because they will always be in equal
concentrations on both sides of the membrane.
There are three classifications of tonicity that one solution can have relative to another. The three
are hypertonic, hypotonic, and isotonic.
Hypertonicity: Hypertonic refers to a greater concentration. In biology, a hypertonic solution is one
with a higher concentration of solutes on the outside of the cell. When a cell is immersed into a
hypertonic solution, the tendency is for water to flow out of the cell in order to balance the concentration
of the solutes.
When plant cells are in a hypertonic solution, the flexible cell membrane pulls away from the rigid cell
wall, but remains joined to the cell wall at points called plasmodesmata. The cell takes on the
appearance of a pincushion, and the plasmodesmata almost cease to function because they become
constricted: a condition known as plasmolysis. In plant cells the terms isotonic, hypotonic and
hypertonic cannot strictly be used accurately because the pressure exerted by the cell wall significantly
affects the osmotic equilibrium point. A hypertonic solution is used in osmotherapy to treat cerebral
hemorrhage.
Hypotonicity: Hypotonic refers to a lesser concentration. A hypotonic solution has a lower
concentration of solutes in its surroundings, so in an attempt to balance concentrations, water will rush
into the cell, causing swelling.

Some organisms have evolved intricate methods of circumventing hypotonicity. For

example, saltwater is hypertonic to the fish that live in it. They need a large surface area in their gills in
contact with seawater for gas exchange, thus they lose water osmotically to the sea from gill cells. They
respond to the loss by drinking large amounts of saltwater, and activelyexcreting the excess salt. This
process is called osmoregulation.
Isotonicity: An isotonic solution is one in which its effective osmole concentration is the same as the
solute concentration of another solution with which it is compared. This occurs, for example, when the
concentration of both water and total solute molecules are the same in an external solution as in the cell
content. Water molecules diffuse through the plasma membrane in both directions, and as the rate of
water diffusion is the same in each direction that cell will neither gain nor lose water.
For example, the osmolarity of Normal saline, 9 grams NaCl dissolved in water to a total volume of one
litre, is a close approximation to the osmolarity of NaCl in blood, i.e. Normal saline is almost isotonic to
blood plasma.
Capsules: Capsules are solid dosage forms with hard or soft shells. They are of various shapes and
sizes, and contain a single dose of one or more active ingredients. The different categories of capsules
that exist include hard, soft, and modified-release capsules. Capsule shells are made of gelatin or other
substances, the consistency of which may be modified by the addition of substances such as glycerol and
sorbitol.
When excipients are used, it is necessary to ensure that they do not adversely affect the stability,
dissolution rate, bioavailability, safety, or efficacy of the active ingredient(s); there must be no
incompatibility between any of the components of the dosage form.
Hard capsules: Hard capsules have shells consisting of two prefabricated cylindrical sections that fit
together. One end of each section is rounded and closed, and the other is open. The contents of hard
capsules are usually in solid form (powder or granules); in certain cases the contents may be in the form
of encapsulated powders or micropellets.
Soft capsules: Soft capsules have thicker shells than hard capsules, and preservatives are usually added.
The shells are of one piece and various shapes. Partial migration of the contents into the shell may occur
(and vice versa) depending on the nature of the materials used and the product in question.
Modified-release capsules: Modified-release capsules are hard or soft capsules in which the contents or
the shell or both contain additives or are prepared by special procedures such as micro-encapsulation
which, separately or together, are designed to modify the rate of release of the active ingredient(s) in the
gastrointestinal tract.
Extended-release capsules: Extended-release capsules are designed to slow the rate of release of the
active ingredient(s) in the gastrointestinal tract.All requirements for these specialized dosage forms are
given in the individual monographs.
Delayed-release capsules (enteric capsules): Delayed-release capsules are hard or soft capsules
prepared in such a manner that either the shell or the contents resist the action of gastric fluid but release
the active ingredient(s) in the presence of intestinal fluid.
Liquid preparations for oral use: Liquid preparations for oral use are usually solutions, emulsions or
suspensions containing one or more active ingredients in a suitable vehicle; they may in some cases
consist simply of a liquid active ingredient used as such. Liquid preparations for oral use are either
supplied in the finished form or, with the exception of Oral emulsions, may also be prepared just before
issue for use by dissolving or dispersing granules or powder in the vehicle stated on the label.
Oral solutions: Oral solutions are clear Liquid preparations for oral use containing one or more active
ingredients dissolved in a suitable vehicle.

Oral emulsions: Oral emulsions are Liquid preparations for oral use containing one or more active
ingredients. They are stabilized oil-in-water dispersions, either or both phases of which may contain
dissolved solids. Solids may also be suspended in Oral emulsions. Oral emulsions may show evidence of
phase separation but are readily redispersed on shaking.
Oral drops: Oral drops are Liquid preparations for oral use that are intended to be administered in small
volumes with the aid of a suitable measuring device. They may be solutions, suspensions or emulsions.
Powders for oral solutions, oral suspensions or oral drops: Powders for oral solutions, suspensions
or drops are multidose preparations consisting of solid, loose, dry particles of varying degrees of
fineness. They contain one or more active ingredients, with or without excipients and, if necessary,
authorized colouring matter and flavouring substances. They may contain antimicrobial preservatives
and other excipients in particular to facilitate dispersion or dissolution and to prevent caking. After
dissolution or suspension in the prescribed liquid, they comply with the requirements for Oral solutions,
Oral suspensions or Oral drops, as appropriate.
Presentations of powder (usually single-dose presentations, for example, a small sachet) that are
intended to be issued to the patient as a powder, to be taken in or with water or another suitable liquid,
are outside the scope of this general monograph. Such preparations are controlled by the monograph for
Oral powders.
Granules for oral solutions or suspensions: Granules for oral solutions or suspensions are multidose
preparations consisting of solid, dry aggregates of powder particles sufficiently resistant to withstand
handling. They contain one or more active ingredients with or without excipients and, if necessary,
authorized colouring matter and flavouring substances. They may contain antimicrobial preservatives
and other excipients in particular to facilitate dispersion or dissolution and to prevent caking. After
dissolution or suspension in the prescribed liquid, they comply with the requirements for Oral solutions
or Oral suspensions, as appropriate.
Presentations of granules that are intended to be issued to the patient as granules to be swallowed as
such, to be chewed, or to be taken in or with water or another suitable liquid, are outside the scope of
this general monograph.
Ophthalmic preparations: Ophthalmic preparations (eye preparations) are sterile, liquid, semi-solid, or
solid preparations that may contain one or more active pharmaceutical ingredient( s) intended for
application to the conjunctiva, the conjunctival sac or the eyelids.
Ophthalmic drops: Ophthalmic drops (eye drops) are sterile aqueous or oily solutions, suspensions, or
emulsions intended for instillation into the conjunctival sac. Ophthalmic drops should be clear and
practically free from particles when examined under suitable conditions of visibility.
Ophthalmic emulsions: Ophthalmic emulsions are generally dispersions of oily droplets in an aqueous
phase. There should be no evidence of breaking or coalescence.
Ophthalmic suspensions: Ophthalmic suspensions contain solid particles dispersed in a liquid vehicle;
they must be homogeneous when shaken gently and remain sufficiently dispersed to enable the correct
dose to be removed from the container. A sediment may occur, but this should disperse readily when the
container is shaken, and the size of the dispersed particles should be controlled. The active ingredient
and any other suspended material must be reduced to a particle size small enough to prevent irritation
and damage to the cornea.
Ophthalmic ointments: Ophthalmic ointments are sterile, homogeneous, semi-solid preparations
intended for application to the conjunctiva or the eyelids. They are usually prepared from non-aqueous
bases, e.g. soft paraffin (Vaseline), liquid paraffin, and wool fat. They may contain suitable additives,
such as antimicrobial agents, antioxidants, and stabilizing agents.

Oral powders: Oral powders are preparations consisting of solid, loose, dry particles of varying degrees
of fineness. They contain one or more active ingredients, with or without excipients and, if necessary,
authorized colouring matter and flavouring substances. They are generally administered in or with water
or another suitable liquid. They may also be swallowed directly. They are presented as single-dose or
multidose preparations.
Effervescent powders: Effervescent powders are presented as single-dose or multidose preparations
and generally contain acidic substances and carbonates or hydrogen carbonates which react rapidly in
the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water
before administration.
Parenteral preparations: Parenteral preparations are sterile, pyrogen-free liquids (solutions, emulsions,
or suspensions) or solid dosage forms containing one or more active ingredients, packaged in either
single-dose or multidose containers. They are intended for administration by injection, infusion, or
implantation into the body.
Preparations such as vaccines, human blood and products derived from human blood, peritoneal dialysis
solutions, and radioactive pharmaceuticals require special formulation, methods of manufacture, or
presentation appropriate to their particular use and may not comply with certain parts of this monograph.
Injections: Injections are sterile, pyrogen-free solutions or dispersions (emulsions or suspensions) of
one or more active ingredients in a suitable vehicle.
Whenever possible, an injection should be prepared using an aqueous vehicle. If necessary, suitable nonaqueous solvents are indicated in the individual monographs. Injections that are dispersions should
remain sufficiently stable so that, after shaking, a homogeneous dose can be withdrawn.
The use of single-dose injections is to be preferred and is essential when the preparation is intended for
administration by routes where, for medical reasons, an antimicrobial preservative is not acceptable, e.g.
intracisternal, intrathecal.
Intravenous infusions: Intravenous infusions are sterile, pyrogen-free aqueous solutions or emulsions
with water as continuous phase, usually prepared to be isotonic. They are intended for administration in
large volumes (usually 100 ml or more), and should not contain any antimicrobial preservatives.On
visual inspection, emulsions for intravenous injection should show no evidence of phase separation. The
particle size of the dispersed phase should be controlled by the manufacturer.
Powders for injections: Powders for injections are solid substances (including freeze-dried materials),
distributed in their final containers and which, when shaken with the prescribed volume of the
appropriate sterile liquid, rapidly form either clear and practically particle-free solutions or uniform
suspensions. Powders for injections, after dissolution or suspension, comply with the requirements for
injections or intravenous infusions, as appropriate.
Implants: Implants are solid preparations containing one or more active ingredients. They are of a size
and shape suitable for parenteral implantation, and provide release of the active ingredient(s) over an
extended period of time. They are presented in individual sterile containers.
Suppositories: Suppositories are solid preparations which may contain one or more active
pharmaceutical ingredient(s) intended for rectal application. They are normally used for local action or
systemic absorption of the active ingredient(s). They usually melt, soften, or dissolve at body
temperature.
Suppositories are usually prepared from excipients or bases such as cocoa butter, hard fat, glycerinated
gelatin, hydrogenated vegetable oils and macrogols. They may also contain additives, such as
adsorbents, surface-active agents, viscosity-influencing agents, antioxidants, antimicrobials, and
authorized colouring agents.

Tablets :Tablets are solid dosage forms containing one or more active ingredients. They are obtained by
single or multiple compression (in certain cases they are moulded) and may be uncoated or coated. They
are usually intended for oral administration, but preparations for alternative applications, such as
implants, solution-tablets for injections, irrigations, or for external use, vaginal tablets, etc., are also
available in this presentation. These preparations may require a special formulation, method of
manufacture, or form of presentation, appropriate to their particular use.
Uncoated tablets: The majority of uncoated tablets are made in such a way that the release of active
ingredients is unmodified. A broken section, when examined under a lens, shows either a relatively
uniform texture (single-layer tablets) or a stratified texture (multi-layer tablets), but no signs of coating.
Soluble tablets (tablets for solutions): Soluble tablets are uncoated tablets that dissolve in water to give
a clear solution.
Effervescent tablets: Effervescent tablets are uncoated tablets generally containing acid substances and
carbonates or hydrogen carbonates that react rapidly in the presence of water to release carbon dioxide.
They are intended to be dissolved or dispersed in water before administration.
Tablets for use in the mouth (sublingual, buccal) and chewable tablets: Tablets for use in the mouth
and chewable tablets are usually uncoated. They are formulated to effect a slow release and local action
of the active ingredient(s) (for example, compressed lozenges) or the release and absorption of the active
ingredient(s) under the tongue (sublingual tablets) or in other parts of the mouth (buccal) for systemic
action.
Coated tablets: Coated tablets are tablets covered with one or more layers of mixtures of substances
such as natural or synthetic resins, polymers, gums, fillers, sugars, plasticizers, polyols, waxes,
colouring matters, flavouring substances, and sometimes also active ingredients. A broken section, when
examined under a lens, shows a core which is surrounded by a continuous layer of a different texture.
The tablets may be coated for a variety of reasons such as protection of the active ingredients from air,
moisture, or light, masking of unpleasant tastes and odours, or improvement of appearance. The
substance used for coating is usually applied as a solution or suspension.
Film-coated tablets: A film-coated tablet is covered with a thin layer of resins, polymers, and/or
plasticizers capable of forming a film.
Modified-release tablets: Modified-release tablets are coated, uncoated, or matrix tablets containing
excipients or prepared by procedures which, separately or together, are designed to modify the rate of
release of the active ingredient(s) in the gastrointestinal tract.
Extended-release tablets: Extended-release tablets are designed to slow the rate of release of the active
ingredient(s) in the gastrointestinal tract.
Delayed-release tablets (enteric-coated tablets): Delayed-release tablets are intended to resist gastric
fluid but disintegrate in intestinal fluid. This is achieved by using coating substances such as cellacefate
(cellulose acetate phthalate) and anionic copolymers of methacrylic acid and its esters. It is sometimes
necessary to apply more than one layer.