Bacteriostatic water for injection is sterile water containing benzyl alcohol at 0.9% as a bacteriostatic preservative. The preservative is what permits multiple withdrawals from a reconstituted vial over an in-use period, in contrast to preservative-free sterile water, which is single-use. It is the standard diluent for lyophilised peptide presentations. The in-use stability period following reconstitution is compound-specific and is stated in the professional documentation supplied with each product. PHI operates a single reconstitution volume across the range to reduce the risk of error at the point of use; the standard and the resulting concentration tables are published behind the professional gate rather than in open marketing material.
Active Compound: Bacteriostatic Water for Injection (0.9% benzyl alcohol)
Permitted Claim GuidelinesSterile diluent containing 0.9% benzyl alcohol for reconstitution of lyophilised product under practitioner direction.
Mechanism of ActionNot applicable - diluent.
Evidence Grade: Not applicable
Clinical Evidence BaseNot applicable - pharmacopoeial diluent.
Literature & ReferencesRefer to the relevant pharmacopoeial monograph for Bacteriostatic Water for Injection.
Safety & PrecautionsBenzyl alcohol is contraindicated in neonates and infants, in whom it has been associated with serious toxicity. Use with caution in patients with known benzyl alcohol sensitivity. Not for use where a preservative-free diluent is specified. Observe the stated in-use period after first puncture and record the date of reconstitution on the vial. Discard if the solution is discoloured or contains particulate matter.
ContraindicationsNeonates and infants; known benzyl alcohol hypersensitivity; any product for which a preservative-free diluent is specified.
Storage & HandlingStore at room temperature, protected from light. Do not freeze. Observe in-use period after first puncture.
Regulatory StatusClassification varies by market: a medicinal product in some jurisdictions and a general sale item in others. Confirm classification and supply permissions per fulfilment hub before listing.