Bacteriostatic Water for Injection, USP

1. Composition:

   • Primary Component: Sterile, purified water that has been filtered and treated to remove impurities, microorganisms, and pyrogens (fever-causing substances).

   • Preservative: Contains 0.9% benzyl alcohol, which prevents bacterial and microbial contamination, allowing the solution to be used multiple times within a specified period (typically up to 28 days after opening).

   • pH: Neutral or slightly adjusted (around 5.7–7.0) to ensure compatibility with injectable compounds.

2. Purpose and Uses:

   • Peptide and Hormone Reconstitution: Bacteriostatic water is commonly used to dissolve lyophilized (freeze-dried) peptides, such as DSIP, GHK-Cu, BPC-157, or others, for research purposes. It creates a stable solution for accurate dosing in experiments.

   • Dilution of Medications: Used to dilute concentrated drugs for intramuscular, subcutaneous, or intravenous administration in clinical or research settings.

   • Multi-Use Capability: The benzyl alcohol preservative allows multiple withdrawals from the same vial, making it practical for repeated dosing in research protocols.

   • Laboratory Applications: Employed in cell culture, microbiology, or other experiments requiring sterile, non-pyrogenic water.

3. Key Properties:

   • Sterility: Manufactured under strict aseptic conditions to ensure no microbial contamination.

   • Bacteriostatic Effect: Benzyl alcohol inhibits bacterial growth, extending the shelf life of an opened vial (typically 28 days when stored properly).

   • Non-Pyrogenic: Free of pyrogens, ensuring safety for injection in research models or clinical settings.

   • Clear and Colorless: Visually indistinguishable from pure water, ensuring no impurities affect reconstituted compounds.

4. Storage and Handling:

   • Storage: Store at room temperature (15–25°C) or refrigerated (2–8°C) to maintain sterility. Avoid freezing, as it may compromise the vial’s integrity.

   • Shelf Life: Unopened vials typically have a shelf life of 1–2 years. Once opened, use within 28 days to prevent contamination.

   • Handling: Use sterile syringes and needles for withdrawal to maintain sterility. Discard if the solution appears cloudy or contains particles.

5. Packaging:

   • Typically supplied in multi-dose vials (e.g., 10 mL or 30 mL) with a rubber stopper for repeated access.

   • Available from pharmaceutical suppliers, labeled for research or medical use.

Considerations and Limitations

• Not for Direct Injection: Bacteriostatic water is a vehicle for reconstitution or dilution, not a standalone injectable. It should only be used with compatible compounds.

• Benzyl Alcohol Sensitivity: Some research models or subjects may be sensitive to benzyl alcohol, potentially causing irritation or allergic reactions at the injection site.

• Not for Neonatal Use: Due to benzyl alcohol, bacteriostatic water is contraindicated in neonates, as it may cause toxicity (e.g., gasping syndrome).

• Contamination Risk: Despite the preservative, improper handling (e.g., using non-sterile needles) can introduce contaminants. Always follow aseptic techniques.

• Regulatory Status: Available for purchase as a research or medical supply, but its use must comply with local regulations. It’s not a drug but a pharmaceutical aid.

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