Accessed from 10.6.1.
1 by brunswick20 on Tue Feb 21 04:30:07 EST 2017
USP 40
• 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.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in unreactive storage
containers that are designed to prevent bacterial entry.
Store at room temperature.
• USP REFERENCE STANDARDS 〈11〉
USP 1,4-Benzoquinone RS
USP Endotoxin RS
USP Sucrose RS
. Analysis: Add 2 mL of ammonium oxalate TS to the
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
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,
Official from null
Copyright (c) 2017 The United States Pharmacopeial Convention. All rights reserved.
Official Monographs / Water 6717
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.
• USP REFERENCE STANDARDS 〈11〉
USP 1,4-Benzoquinone RS
USP Endotoxin RS
USP Sucrose RS
.
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-
USP Monographs
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
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-
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