Bacteriostatic Water

Bacteriostatic Water for Injection, USP

Product Overview

Bacteriostatic Water for Injection, USP is a sterile, non-pyrogenic preparation of water containing 0.9% (9 mg/mL) benzyl alcohol as a bacteriostatic preservative. This formulation allows for multiple withdrawals from a single vial, making it suitable for repeated use in diluting or dissolving drugs for parenteral administration. It is supplied in multiple-dose containers, typically 30 mL plastic vials with a flip-top lid, and has a pH range of 4.5 to 7.0.

Key Ingredients

• Sterile water for injection (H₂O)

• Benzyl alcohol (0.9% or 9 mg/mL) – acts as a preservative to inhibit bacterial growth

Intended Use

This product is designed solely for parenteral use after the addition of drugs that require dilution or dissolution in an aqueous vehicle prior to injection (e.g., intravenous, intramuscular, or subcutaneous). It is commonly used in medical, laboratory, and pharmaceutical settings for reconstituting medications, peptides, or other injectables. The preservative enables safe multiple punctures of the vial for up to 28 days after opening, unlike sterile water which is single-use only.

Warnings and Precautions

• Not for direct injection: Administering Bacteriostatic Water without a solute may cause hemolysis (red blood cell rupture).

• Neonates and infants: Contraindicated for use in neonates due to the risk of benzyl alcohol toxicity; use preservative-free Sterile Water for Injection instead.

• Pregnancy and breastfeeding: Category C; benzyl alcohol may cross into breast milk and pose risks to infants. Consult a healthcare provider.

• Hypersensitivity: Avoid in patients with known allergy to benzyl alcohol.

• Storage: Store at controlled room temperature (20–25°C or 68–77°F). Inspect for particulate matter or discoloration before use. Discard after 28 days or if contaminated.

• Not for irrigation: Due to the preservative, it is unsuitable for wound irrigation or flushing.

This product is manufactured by reputable suppliers such as Hospira (Pfizer) and is widely available for medical and research purposes. Always follow healthcare professional guidance for safe use.