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• WATER CONDUCTIVITY, Bulk Water 〈645〉: Meets the Bacteriostatic Water for Injection
requirements [NOTE—For microbiological guidance, see general informa-
• BACTERIAL ENDOTOXINS TEST 〈85〉: It contains less than 1 tion chapter Water for Pharmaceutical Purposes 〈1231〉.]
USP Endotoxin Unit/mL.
DEFINITION
ADDITIONAL REQUIREMENTS Bacteriostatic Water for Injection is prepared from Water for
• PACKAGING AND STORAGE: Preserve in unreactive storage Injection that is sterilized and suitably packaged, contain-
USP Monographs
containers that are designed to prevent bacterial entry. ing one or more suitable antimicrobial agents.
Store at room temperature. [NOTE—Use Bacteriostatic Water for Injection with due re-
• USP REFERENCE STANDARDS 〈11〉 gard for the compatibility of the antimicrobial agent or
USP 1,4-Benzoquinone RS agents it contains with the particular medicinal substance
USP Endotoxin RS that is to be dissolved or diluted.]
USP Sucrose RS
SPECIFIC TESTS
• CALCIUM
Sample: 100 mL
. Analysis: Add 2 mL of ammonium oxalate TS to the
Water for Injection Sample.
Acceptance criteria: No turbidity is produced.
[NOTE—For microbiological guidance, see general informa- • CARBON DIOXIDE
tion chapter Water for Pharmaceutical Purposes 〈1231〉.] Sample: 25 mL
Analysis: Add 25 mL of calcium hydroxide TS to the
H2O 18.02 Sample.
DEFINITION Acceptance criteria: The mixture remains clear.
Water for Injection is water purified by distillation or a purifi- • SULFATE
cation process that is equivalent or superior to distillation Sample: 100 mL
in the removal of chemicals and microorganisms. It is pre- Analysis: Add 1 mL of barium chloride TS to the
pared from water complying with the U.S. Environmental Sample.
Protection Agency National Primary Drinking Water Regu- Acceptance criteria: No turbidity is produced.
lations or with the drinking water regulations of the Euro- • PH 〈791〉
pean Union or of Japan or with the World Health Organi- Sample: To 100 mL of Bacteriostatic Water for Injection
zation’s Guidelines for Drinking Water Quality. It contains add 0.3 mL of saturated potassium chloride solution.
no added substance. Acceptance criteria: 4.5–7.0
[NOTE—Water for Injection, whether it is available in bulk or • ANTIMICROBIAL AGENT(S): Meets the requirements in Anti-
packaged forms, is intended for use in the preparation of microbial Effectiveness Testing 〈51〉, and meets the labeled
parenteral solutions. Where used for the preparation of claim for content of the antimicrobial agent(s), as deter-
parenteral solutions subject to final sterilization, use suita- mined by the method set forth in Antimicrobial Agents—
ble means to minimize microbial growth, or first render Content 〈341〉
the Water for Injection sterile and, thereafter, protect it • STERILITY TESTS 〈71〉: Meets the requirements
from microbial contamination. For parenteral solutions • PARTICULATE MATTER IN INJECTIONS 〈788〉: Meets the
that are prepared under aseptic conditions and are not requirements
sterilized by appropriate filtration or in the final container, • BACTERIAL ENDOTOXINS TEST 〈85〉: Less than 0.5 USP En-
first render the Water for Injection sterile and, thereafter, dotoxin Unit/mL