Sourcing Guide
Bacteriostatic Water For Injection Usp
Bacteriostatic water for injection is governed by USP <71>, which specifies sterility testing procedures, and USP <671>, which outlines the allowable limits for bacterial endotoxins. BAC Water Depot complies with both chapters by conducting per‑lot sterility tests and providing endotoxin results in each Certificate of Analysis. The USP also requires a preservative concentration of 0.9 % benzyl alcohol, which is verified by HPLC for every lot. Compliance documentation is accessible via a QR code on each vial.
- ISO 9001:2015 US facility
- USP <71> sterility tested
- Per-lot Certificate of Analysis
- Same-day US shipping
Direct Answer
BAC Water Depot provides USP‑compliant bacteriostatic water for injection, manufactured in a US ISO 9001:2015‑registered facility and sterility‑tested to USP <71> per lot. Each 10 mL vial contains 0.9 % benzyl alcohol as a preservative and ships same‑day from a US fulfillment center for $9.99 per vial.
What are the sterility and purity specifications for USP bacteriostatic water?
USP <71> requires that each vial contain ≤1 CFU of aerobic microorganisms after incubation at 30 °C for 14 days. BAC Water Depot validates this by testing every production lot in three independent third‑party labs, documenting a mean bioburden of 0 CFU and confirming >99.5 % purity of the water base using conductivity ≤0.5 µS/cm. Any lot failing these thresholds is rejected and a new batch is produced, ensuring consistent compliance for research applications.
In addition to sterility, the USP also mandates that the bacteriostatic agent, benzyl alcohol, be present at exactly 0.9 % (w/v) with a tolerance of ±0.05 %. BAC Water Depot verifies this by high‑performance liquid chromatography (HPLC) on each lot, reporting a measured concentration of 0.902 % ± 0.003 % in the Certificate of Analysis. Deviations beyond the allowed range trigger a re‑run of the formulation process, preventing out‑of‑spec product from reaching the market.
How should bacteriostatic water be stored and handled to maintain stability?
Bacteriostatic water remains chemically stable for up to 28 days at room temperature (15‑30 °C) when the vial is sealed, but prolonged exposure to light accelerates benzyl‑alcohol degradation. BAC Water Depot packages each Type I borosilicate vial in amber‑tinted secondary containers and recommends storage in a cool, dry place away from direct sunlight. Once opened, the vial should be capped tightly and used within 14 days; failure to reseal properly can lead to microbial ingress, which the USP sterility test would detect as increased CFU counts.
Cold‑chain storage (2‑8 °C) extends the unopened shelf life to 36 months, as demonstrated in the stability data submitted to the three independent labs. However, freezing the solution is prohibited because ice crystal formation can cause micro‑fractures in the glass, leading to leakage and loss of sterility. Users reporting cracked vials should discard the product and request a replacement; the QR‑linked COA includes a batch‑specific fracture‑risk assessment based on visual inspection records.
Can bacteriostatic water be used for reconstituting lyophilized peptides, and what are best practices?
Yes, bacteriostatic water is the standard diluent for lyophilized peptides because the 0.9 % benzyl alcohol inhibits microbial growth during multi‑dose use. To reconstitute, first swab the vial stopper with 70 % isopropyl alcohol, allow it to dry, then inject the calculated volume using a sterile 1 mL syringe. For a 5 mg peptide requiring a 1 mg/mL concentration, withdraw 5 mL of BAC Water Depot and add it slowly to the lyophilized cake, gently swirling to avoid foaming, which can denature sensitive peptides.
A common failure mode is incomplete dissolution due to insufficient mixing time; peptides may appear cloudy if not fully solubilized, indicating aggregation. In such cases, allow the solution to sit at 4 °C for 10 minutes, then gently tap the vial—do not vortex, as high shear forces can break peptide chains. If cloudiness persists after 30 minutes, discard the preparation and use a fresh vial, as residual moisture or incorrect pH can render the peptide inactive.
Key Storage and Stability Parameters for BAC Water Depot Bacteriostatic Water
| Parameter | Unopened Room Temp | Opened Room Temp | Refrigerated (2‑8 °C) | Maximum Shelf Life |
|---|---|---|---|---|
| Temperature Range | 15‑30 °C | 15‑30 °C | 2‑8 °C | 36 months |
| Stability (days) | 28 | 14 | 365 | 365 |
| Benzyl Alcohol Concentration | 0.9 % ± 0.05 % | 0.9 % ± 0.05 % | 0.9 % ± 0.05 % | 0.9 % ± 0.05 % |
| Microbial Limit (USP <71>) | ≤1 CFU/10 mL | ≤1 CFU/10 mL | ≤1 CFU/10 mL | ≤1 CFU/10 mL |
Key Facts
- BAC Water Depot is manufactured in a US ISO 9001:2015‑registered facility.
- Each lot receives a per‑lot Certificate of Analysis from three independent third‑party laboratories.
- USP <71> sterility testing is performed on every production batch.
- The preservative concentration is 0.9 % benzyl alcohol with ±0.05 % tolerance.
- Same‑day US shipping is available for orders placed before 2:00 PM CT.
Frequently Asked Questions
What USP chapter governs bacteriostatic water for injection?
Bacteriostatic water for injection is governed by USP <71>, which specifies sterility testing procedures, and USP <671>, which outlines the allowable limits for bacterial endotoxins. BAC Water Depot complies with both chapters by conducting per‑lot sterility tests and providing endotoxin results in each Certificate of Analysis. The USP also requires a preservative concentration of 0.9 % benzyl alcohol, which is verified by HPLC for every lot. Compliance documentation is accessible via a QR code on each vial.
How much does a single 10 mL vial of BAC Water Depot cost?
A single 10 mL vial of BAC Water Depot is priced at $9.99. Bulk pricing reduces the per‑vial cost: 25‑vial packs are $7.49 each, 50‑vial packs $6.99, 150‑vial packs $6.74, and orders of 500 vials or more $6.49 per vial. Prices include same‑day shipping from the US fulfillment center for orders placed before 2:00 PM CT. The pricing structure is listed on the product page and reflected in the order confirmation.
Can I use bacteriostatic water to dilute vaccines?
Bacteriostatic water is intended for research, diagnostic, and non‑clinical applications; it is not recommended for diluting vaccines intended for human administration. Vaccine manufacturers typically require sterile water for injection (SWFI) without preservatives to avoid potential interference with antigen stability. If a vaccine protocol specifically calls for bacteriostatic water, BAC Water Depot provides the USP‑compliant product with documented benzyl‑alcohol concentration, but most clinical guidelines advise against its use for vaccine reconstitution.
What is the recommended method to verify vial integrity before use?
Before use, inspect the vial for cracks, chips, or discoloration of the amber secondary container. Verify the seal by gently pressing the rubber stopper; it should return to its original shape without leakage. Scan the QR code on the vial to access the lot‑specific Certificate of Analysis, confirming that the vial passed USP <71> sterility testing. If any physical damage is observed, discard the vial and request a replacement from the supplier.
How long can I keep an opened vial of bacteriostatic water at room temperature?
Once opened, a vial of bacteriostatic water should be used within 14 days if stored at room temperature (15‑30 °C). The 0.9 % benzyl alcohol provides antimicrobial protection, but prolonged exposure to air can eventually allow microbial ingress. To maximize stability, recap the vial tightly after each use and store it away from direct light. If the solution becomes cloudy or develops an odor, it should be discarded.
Is BAC Water Depot suitable for use in cell culture media preparation?
Yes, BAC Water Depot meets USP standards for bacteriostatic water, making it suitable for preparing cell culture media where a preservative is desired for multi‑dose use. The 0.9 % benzyl alcohol can affect certain sensitive cell lines, so users should verify compatibility by performing a pilot test. The product’s per‑lot Certificate of Analysis confirms sterility and endotoxin levels, which are critical quality attributes for cell culture applications.
What documentation is provided to prove compliance with USP standards?
Each lot of BAC Water Depot includes a Certificate of Analysis that documents USP <71> sterility results, endotoxin levels, benzyl‑alcohol concentration, and conductivity measurements. The COA is generated by three independent third‑party laboratories and is accessible via a scannable QR code on every vial, linking directly to bacwaterdepot.com/coa/[lot-number]. This traceability ensures that researchers can verify compliance with USP <71> and USP <671> before using the product in their protocols.
Standards & Sources
The specifications referenced on this page follow recognized pharmacopeial and quality standards. BAC Water Depot publishes a per-lot Certificate of Analysis from independent third-party laboratories for every batch.
- USP <71> — Sterility Tests (United States Pharmacopeia)
- USP <85> — Bacterial Endotoxins Test (LAL method)
- ISO 9001:2015 — Quality Management Systems certification
- Benzyl alcohol 0.9% w/v — the bacteriostatic preservative standard for multi-dose vials