INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS) —PRODUCT

QUALITY TESTS

Universal Tests

1. IDENTIFICATION
2. ASSAY
3. IMPURITIES
4. FOREIGN AND PARTICULATE MATTER
 EACH final container of all parenteral preparations should be
inspected to the extent possible for the presence of observable foreign
and particulate matter (hereafter termed visible particulates) in its
contents
 may take place during examination for other defects such as cracked
or defective containers or seals, or when characterizing the
appearance of a lyophilized product
5. STERILITY
6. BACTERIAL ENDOTOXINS
7. CONTAINER CONTENT
8. PACKAGING SYSTEMS
 packaging system should not interact physically or chemically with
the preparation to alter its strength, quality, or purity beyond the
official or established requirements
9. CONTAINER-CLOSURE INTEGRITY
 packaging system should be closed or sealed in such a manner as to
prevent contamination or loss of contents
10. LABELING

Specific Tests

1. UNIFORMITY OF DOSAGE UNITS

 for parenteral drug products and dosage forms packaged in single-
unit containers
2. VEHICLES AND ADDED SUBSTANCES
 Aqueous vehicles
 Nonaqueous vehicles
 Added substances
o suitable substances may be added to preparations in order to
increase stability or usefulness unless they are prescribed in
the monograph
o no coloring agent may be added to a preparation solely for the
purpose of coloring the finished preparation
3. ANTIMICROBIAL PRESERVATIVES
 Antimicrobial agents must be added to preparations intended for
injection that are packaged in multiple-dose containers
 4. WATER CONTENT
 water content of freeze-dried (lyophilized) products should be
determined when appropriate
5. ALUMINUM CONTENT
6. COMPLETENESS AND CLARITY OF SOLUTIONS

Product Quality Tests for Specific Parenteral Dosage Forms

Solutions
1. Universal Tests
2. Specific Tests
a. Antimicrobial Preservatives

Sterile Powders for Solutions

1. Universal Tests
2. Uniformity of Dosage Units
3. Loss on Drying
4. Water Determination
5. Appearance

Suspensions
1. Universal Tests
2. Specific Tests
a. Uniformity of Dosage Units
b. Antimicrobial Preservatives

Liposomes
1. Universal Tests
2. Specific Tests
a. Globule Size Distribution in Lipid Injectable Emulsions

Sterile Powder for Suspensions

1. Universal Tests
2. Microparticles

Emulsions
1. Universal Tests
2. Specific Tests
a. Globule Size Distribution in Lipid Injectable Emulsions

Implants
1. Universal Tests
2. Specific Tests
a. Uniformity of Dosage Units

In situ gels
 1. Universal Tests
2. Specific Tests
a. Antimicrobial Preservatives

Microparticles
1. Universal Tests
2. Specific Tests
a. Uniformity of Dosage Units
b. Water Content

Drug-Eluting Stents
1. Universal Tests
2. Specific Tests
3. Uniformity of Dosage Units
4. Biological Reactivity tests, In Vivo