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Bacteriostatic Water for Injection, USP is: chemically designated H2O and is a sterile, non-pyrogenic preparation of water containing 0.9% (9mg/mL) of benzyl alcohol added as a preservative and has a pH of 5.7 (4.5 - 7.0)

The committee will then produce a Draft Guideline which will be sent to all Stakeholders who will be invited to comment

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