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Category Pharmaceutic aid (sterile vehicle).

      Bacteriostatic Water for Injection is prepared from Water for Injection that is sterilized and suitably packaged, containing one or more suitable antimicrobial agents.

(Note Bacteriostatic Water for Injection is intended to be used as a diluent in the preparation of parenteral products, most typically for multi-dose products that require repeated content withdrawals. Use Bacteriostatic Water for Injection with due regard for the compatibility of the antimicrobial agent(s) it contains with the particular medicinal substance that is to be dissolved or diluted.)

Description Clear, colourless liquid; odourless or having the odour of the antimicrobial substance.

Packaging and storage Bacteriostatic Water for Injection shall be kept in single-dose or multiple-dose glass containers, preferably of Type I or Type II glass, or plastic containers, of not larger than 30-ml size.

Labelling The label on the container states the designation “NOT FOR USE IN NEWBORNS” in boldface capital letters on the label immediately under the official name, printed in a contrasting colour, preferably red. Alternatively, the statement may be placed prominently elsewhere on the label if the statement is enclosed within a box.

pH 4.5 to 7.0, determined potentiometrically in a solution prepared by the addition of 0.30 ml of a saturated solution of potassium chloride to 100 ml of the test substance (Appendix 4.11).

Calcium To 100 ml add 2 ml of ammonium oxalate TS: no turbidity is produced.

Carbon dioxide To 25 ml add 25 ml of calcium hydroxide TS: the mixture remains clear.

Sulfate To 100 ml add 1 ml of barium chloride TS: no turbidity is produced.

Particulate matter Complies with the requirements described under “Particulate Matter in Injections” (Small-volume Injection, Appendix 4.27).

Antimicrobial agent(s) Complies with the “Efficacy of Antimicrobial Preservation” (Appendix 10.6) and the “Content of Antimicrobial Agents” (Appendix 6.22).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains less than 0.5 Endotoxin Unit per ml.

Sterility Complies with the “Sterility Test” (Appendix 10.1).