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Pharmaceutical Guideline
Manufacturing and Packaging

BACTERIOSTATIC WATER FOR INJECTION

BWI is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives.

Pharmaceutical Guideline1 min read
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Bacteriostatic Water for Injection 30 mL multiple-dose label with 0.9% benzyl alcohol and a not for use in neonates warning

Label for 30 mL multiple-dose Bacteriostatic Water for Injection, for drug diluent use only, with 0.9% benzyl alcohol added and a warning not for use in neonates

BACTERIOSTATIC WATER FOR INJECTION is Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives. It 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. It may be packaged in single-dose or multiple-dose containers not larger than 30 mL.

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