Accessed from 69.43.75.
69 by mcphs1 on Mon Sep 17 13:15:52 EDT 2018
USP 41
System suitability
Samples: Standard solution and System suitability
solution
[NOTE—The relative retention times for warfarin and
warfarin related compound A are about 1.0 and 1.4,
respectively.]
Suitability requirements
Resolution: NLT 2 between warfarin and warfarin re-
lated compound A peaks, System suitability solution
Relative standard deviation: NMT 5.0%, Standard
solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of Alice’s ketone in the por-
tion of Tablets taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × (1/F) × 100
rU = peak response of warfarin related compound A
from the Sample solution
rS = peak response of warfarin from the Standard
solution
CS = concentration of USP Warfarin RS in the
Standard solution (mg/mL)
CU = concentration of warfarin sodium in the
Sample solution (mg/mL)
Mr1 = molecular weight of warfarin sodium, 330.31
Mr2 = molecular weight of warfarin, 308.33
F = relative response factor for Alice’s ketone, 0.9
[NOTE—Alice’s ketone is a sodium salt of warfarin re-
lated compound A, 3-(o-hydroxyphenyl)-5-phenyl-
2-cyclohexen-1-one sodium salt.]
Acceptance criteria: NMT 0.5%
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight, light-resistant
containers. Store at controlled room temperature.
• USP REFERENCE STANDARDS 〈11〉
USP Warfarin RS
USP Warfarin Related Compound A RS
3-(o-Hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one.
C18H16O2 264.33
.
Water for Hemodialysis
[NOTE—See Water for Hemodialysis Applications 〈1230〉 for
guidelines on microbial and chemical testing.]
H2O 18.02
DEFINITION
Water for Hemodialysis is water that complies with the U.S.
Environmental Protection Agency National Primary Drink-
ing Water Regulations and that has been subjected to fur-
ther treatment, using a suitable process, to reduce chemi-
cal and microbiological components. It is produced and
used onsite under the direction of qualified personnel. It
contains no added antimicrobials and is not intended for
injection.
SPECIFIC TESTS
• TOTAL ORGANIC CARBON 〈643〉: Meets the requirements
• MICROBIAL ENUMERATION TESTS 〈61〉 and TESTS FOR SPECI-
FIED MICROORGANISMS 〈62〉: The total aerobic microbial
count does not exceed 100 cfu/mL. It meets the require-
ments of the test for absence of Pseudomonas aeruginosa.
• WATER CONDUCTIVITY, Bulk Water 〈645〉: Meets the
requirements
• BACTERIAL ENDOTOXINS TEST 〈85〉: It contains less than 1
USP Endotoxin Unit/mL.
Official from August 1, 2018
Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.
Official Monographs / Water 4345
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in unreactive storage
containers that are designed to prevent bacterial entry.
Store at room temperature.
Change to read:
• USP REFERENCE STANDARDS 〈11〉
USP 1,4-Benzoquinone RS
•• (CN 1-May-2018)
.
.
Water for Injection
[NOTE—For microbiological guidance, see general informa-
tion chapter Water for Pharmaceutical Purposes 〈1231〉.]
H2O 18.02
DEFINITION
Water for Injection is water purified by distillation or a purifi-
cation process that is equivalent or superior to distillation
in the removal of chemicals and microorganisms. It is pre-
pared from water complying with the U.S. Environmental
Protection Agency National Primary Drinking Water Regu-
lations or with the drinking water regulations of the Euro-
pean Union or of Japan or with the World Health Organi-
zation’s Guidelines for Drinking Water Quality. It contains
no added substance.
[NOTE—Water for Injection, whether it is available in bulk or
packaged forms, is intended for use in the preparation of
parenteral solutions. Where used for the preparation of
parenteral solutions subject to final sterilization, use suita-
ble means to minimize microbial growth, or first render
the Water for Injection sterile and, thereafter, protect it
from microbial contamination. For parenteral solutions
USP Monographs
that are prepared under aseptic conditions and are not
sterilized by appropriate filtration or in the final container,
first render the Water for Injection sterile and, thereafter,
protect it from microbial contamination. In addition to
the Specific Tests, Water for Injection that is packaged for
commercial use elsewhere meets the additional require-
ments for Packaging and Storage and Labeling as indicated
under Additional Requirements.]
SPECIFIC TESTS
[NOTE—Required for bulk and packaged forms of Water for
Injection.]
• BACTERIAL ENDOTOXINS TEST 〈85〉: Less than 0.25 USP En-
dotoxin Unit/mL
• WATER CONDUCTIVITY, Bulk Water 〈645〉: Meets the
requirements
• TOTAL ORGANIC CARBON 〈643〉: Meets the requirements
ADDITIONAL REQUIREMENTS
[NOTE—Required for packaged forms of Water for Injection.]
• PACKAGING AND STORAGE: Where packaged, preserve in
unreactive storage containers that are designed to pre-
vent microbial entry.
• LABELING: Where packaged, label the article to state that
it contains no antimicrobial or other substance, and that
it is not intended for direct parenteral administration.
Change to read:
• USP REFERENCE STANDARDS 〈11〉
USP 1,4-Benzoquinone RS
•• (CN 1-May-2018)
.
 Accessed from 69.43.75.69 by mcphs1 on Mon Sep 17 13:15:52 EDT 2018
4346 Water / Official Monographs
. DEFINITION
Bacteriostatic Water for Injection
[NOTE—For microbiological guidance, see general informa-
tion chapter Water for Pharmaceutical Purposes 〈1231〉.]
DEFINITION
Bacteriostatic Water for Injection is prepared from Water for
Injection that is sterilized and suitably packaged, contain-
ing one or more suitable antimicrobial agents.
[NOTE—Use Bacteriostatic Water for Injection with due re-
gard for the compatibility of the antimicrobial agent or
agents it contains with the particular medicinal substance
that is to be dissolved or diluted.]
SPECIFIC TESTS
• CALCIUM
Sample: 100 mL
Analysis: Add 2 mL of ammonium oxalate TS to the
Sample.
Acceptance criteria: No turbidity is produced.
• CARBON DIOXIDE
Sample: 25 mL
Analysis: Add 25 mL of calcium hydroxide TS to the
Sample.
Acceptance criteria: The mixture remains clear.
• SULFATE
Sample: 100 mL
Analysis: Add 1 mL of barium chloride TS to the
Sample.
Acceptance criteria: No turbidity is produced.
• PH 〈791〉
Sample: To 100 mL of Bacteriostatic Water for Injection
add 0.3 mL of saturated potassium chloride solution.
Acceptance criteria: 4.5–7.0
• ANTIMICROBIAL AGENT(S): Meets the requirements in Anti-
microbial Effectiveness Testing 〈51〉, and meets the labeled
claim for content of the antimicrobial agent(s), as deter-
USP Monographs
mined by the method set forth in Antimicrobial Agents—
Content 〈341〉
• STERILITY TESTS 〈71〉: Meets the requirements
• PARTICULATE MATTER IN INJECTIONS 〈788〉: Meets the
requirements
• BACTERIAL ENDOTOXINS TEST 〈85〉: Less than 0.5 USP En-
dotoxin Unit/mL
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in single-dose or mul-
tiple-dose glass or plastic containers. Glass containers are
preferably of Type I or Type II glass, of not larger than
30-mL size.
• LABELING: Label it to indicate the name(s) and propor-
tion(s) of the added antimicrobial agent(s). Label it also
to include the statement “Not For Use In Newborns”, in
boldface capital letters on the label immediately under
the official name, printed in a contrasting color, prefera-
bly red. Alternatively, the statement may be placed
prominently elsewhere on the label if the statement is
enclosed within a box.
Delete the following:
•• USP REFERENCE STANDARDS 〈11〉
.
USP Endotoxin RS
• (CN 1-May-2018)
.
Sterile Water for Inhalation
[NOTE—For microbiological guidance, see Water for Pharma-
ceutical Purposes 〈1231〉.]
H2O 18.02
Official from August 1, 2018
Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.
USP 41
Sterile Water for Inhalation is prepared from Water for Injec-
tion that is sterilized and suitably packaged. It contains no
added antimicrobial agents. [NOTE—Do not use Sterile
Water for Inhalation for parenteral administration or for
other sterile compendial dosage forms.]
SPECIFIC TESTS
• OXIDIZABLE SUBSTANCES
Sample: 100 mL
Analysis: Add 10 mL of 2 N sulfuric acid, and heat to
boiling. For Sterile Water for Inhalation in containers
having a fill volume of less than 50 mL, add 0.4 mL of
0.02 M potassium permanganate, and boil for 5 min;
where the fill volume is 50 mL or more, add 0.2 mL of
0.02 M potassium permanganate, and boil for 5 min. If
a precipitate forms, cool in an ice bath to room tem-
perature, and pass through a sintered-glass filter.
Acceptance criteria: The pink color does not com-
pletely disappear. Alternatively, perform the test for To-
tal Organic Carbon 〈643〉, Sterile Water.
• TOTAL ORGANIC CARBON, Sterile Water 〈643〉: Meets the
requirements. Alternatively, perform the test for Oxidiza-
ble Substances.
• WATER CONDUCTIVITY, Sterile Water 〈645〉: Meets the
requirements
• STERILITY TESTS 〈71〉: Meets the requirements
• BACTERIAL ENDOTOXINS TEST 〈85〉: Less than 0.5 USP En-
dotoxin Unit/mL
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in glass or plastic con-
tainers. Glass containers are preferably of Type I or Type
II glass.
• LABELING: Label it to indicate that it is for inhalation ther-
apy only and that it is not for parenteral administration.
Change to read:
• USP REFERENCE STANDARDS 〈11〉
USP 1,4-Benzoquinone RS
•• (CN 1-May-2018)
.
.
Sterile Water for Injection
[NOTE—For microbiological guidance, see Water for Pharma-
ceutical Purposes 〈1231〉.]
H2O 18.02
DEFINITION
Sterile Water for Injection is prepared from Water for Injec-
tion that is sterilized and suitably packaged. It contains no
antimicrobial agent or other added substance.
SPECIFIC TESTS
• OXIDIZABLE SUBSTANCES
Sample: 100 mL
Analysis: Add 10 mL of 2 N sulfuric acid, and heat to a
boil. For Sterile Water for Injection in containers having
a fill volume less than 50 mL, add 0.4 mL of 0.02 M
potassium permanganate, and boil for 5 min; where the
fill volume is 50 mL or more, add 0.2 mL of 0.02 M
potassium permanganate, and boil for 5 min. If a pre-
cipitate forms, cool in an ice bath to room temperature,
and pass through a sintered-glass filter.
Acceptance criteria: The pink color does not com-
pletely disappear. Alternatively, perform the test for To-
tal Organic Carbon 〈643〉, Sterile Water.
• TOTAL ORGANIC CARBON, Sterile Water 〈643〉: Meets the
requirements. Alternatively, perform the test for Oxidiza-
ble Substances.