Description
Hospira® Bacteriostatic Water for Injection, USP — 30 mL Multi-Dose Vial
Technical Data Sheet · Wholesale Procurement · Pfizer/Hospira Manufacturing
Composition, pH, and Preservation Standards
Bacteriostatic Water for Injection, USP is sterile water preserved with 0.9% (9 mg/mL) benzyl alcohol as a bacteriostatic agent. The inclusion of benzyl alcohol inhibits microbial growth between successive punctures, qualifying this product as a multi-dose diluent suitable for repeated access under aseptic conditions. Each vial is pyrogen-free and manufactured to United States Pharmacopeia monograph standards.
| Parameter | Specification | Standard / Method |
|---|---|---|
| Active ingredient | Water for Injection, USP | USP Monograph |
| Preservative | Benzyl alcohol 0.9% (9 mg/mL) | USP <51> Antimicrobial Effectiveness |
| pH range | 4.5 – 7.0 | USP <791> pH determination |
| Osmolarity | ~9 mOsmol/L (calculated) | USP <785> |
| Endotoxin limit | < 0.5 EU/mL | USP <85> Bacterial Endotoxins Test |
| Sterility | Sterile; pyrogen-free | USP <71> Sterility Tests |
| Container closure | Plastic flip-top vial, latex-free stopper | USP <381> / <661> |
| Fill volume | 30 mL nominal | USP <1> Injections and Implanted Drug Products |
Visual Markers of Genuine Hospira Supply
Authentic Hospira 30 mL vials can be verified through several manufacturing-specific markers. The flip-top cap is produced via a blow-fill-seal process with distinct beveled edges. The lot number and expiry date are heat-stamped directly into the plastic vial body—not applied as an inkjet label—making them resistant to abrasion. The printed label carries the Pfizer/Hospira trade dress with NDC 0409-3977-03 in machine-readable GS1-128 barcode format.
The 28-Day Rule for Punctured Multi-Dose Vials
Unopened vials should be labd at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from light. USP <797> and CDC multi-dose vial policy require that once a vial is first punctured, it must be date-labeled and discarded within 28 days, regardless of the remaining volume. The bacteriostatic agent does not provide indefinite protection against contamination.
| Condition | Requirement | Regulatory Basis |
|---|---|---|
| Unopened storage | 20°C – 25°C; avoid freezing | USP <659> Packaging and Storage |
| Post-puncture use | 28 days maximum from first use | USP <797>; CDC MDV Policy |
| Post-puncture labeling | Date of first puncture recorded on vial | USP <797> §5.3 |
| Discard conditions | Turbidity, discoloration, visible particles | USP <1>; Hospira PI |
Aseptic Technique (USP <797> Guidelines)
- Verify vial integrity and expiry. Confirm NDC 0409-3977-03 and lot number against CoA documentation.
- Perform hand hygiene and don appropriate PPE (gloves, gown, mask) in accordance with institutional SOP.
- Disinfect the rubber stopper of the Hospira vial and the lyophilized vial with a sterile 70% isopropyl alcohol swab; allow 30 seconds to dry.
- Using a sterile luer-lock syringe, withdraw the required quantity. Direct the diluent stream against the interior wall of the vial to reduce foaming.
- Gently swirl — do not vortex — until reconstitution is complete. Label the vial with preparation date and record the date of first puncture on the Hospira vial.
| Contraindication | Detail |
|---|---|
| Neonates | Absolutely contraindicated due to fatal toxicity. |
| Hypersensitivity | Contraindicated for known benzyl alcohol hypersensitivity. |
| Direct IV Infusion | Not formulated for direct IV infusion; diluent use only. |
Bulk Ordering and Case Configurations
Institutional procurement is available in case quantitiesfor licensed healthcare facilities, pharmacy departments, and research institutions. Purchase orders should reference NDC 0409-3977-03.
| Pack Config | Units |
|---|---|
| Single Vial (30 mL) | 1 Unit |
| 3-Pack Value Bundle | 3 Units |
| 5-Pack Research Case | 5 Units |





Ryan –
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What stood out most was the batch number printed on the bottle, which I was able to verify independently. That gave me real confidence that this was a legitimate, unaltered product and not a repackaged or counterfeit item, which is unfortunately common with this type of product online.
The bottle was well-sealed, shipping was handled carefully, and the product itself has been exactly as described. For anyone hesitant about ordering bacteriostatic water online, this seller delivers the real thing. Will be ordering from bacteriostaticwaterlab again.