Product Release Record
Bacteriostatic Water for Injection, USP
BAC WATER DEPOT
ISO 9001:2015 registered facility · United States
bacwaterdepot.com
§ 1 — Lot Information
Manufactured
2026-04-08
QA Released
2026-04-22
Retest By
2027-04-08
Expiration
2028-05-31
Storage
Store at controlled room temperature 15–30 °C (59–86 °F). Once punctured, refrigerate 2–8 °C and discard after 28 days.
§ 2 — Appearance
Clear, colorless solution, free of visible particulate matter under USP <790> conditions
§ 3 — Release Testing Specifications & Results
Tested in accordance with United States Pharmacopeia (USP) methods cited below.
| Test | Specification | Result | P/F |
|---|---|---|---|
Sterility USP <71> | No microbial growth in 14-day membrane filtration test | PASS — no growth detected in test or media controls | ✓ P |
Bacterial Endotoxin USP <85> · LAL kinetic chromogenic | ≤ 0.25 EU/mL | < 0.10 EU/mL | ✓ P |
Bacteriostatic Effectiveness USP <51> · Antimicrobial Effectiveness | Category 1B inhibition criteria met | PASS — log reduction meets USP <51> Category 1B at 14 + 28 days | ✓ P |
Benzyl Alcohol Concentration USP <621> · HPLC-UV | 0.90 % w/v ± 5 % | 0.92 % w/v | ✓ P |
Identification (Benzyl Alcohol) FTIR vs. reference standard | Conforms to reference spectrum | PASS — spectrum match index 99.4 % | ✓ P |
pH USP <791> · potentiometric | 4.5 – 7.0 | 5.6 | ✓ P |
Water Content / Purity Karl Fischer titration | ≥ 98 % water (excluding benzyl alcohol) | 99.05 % water | ✓ P |
Particulate Matter — Subvisible (≥ 10 µm) USP <788> · light obscuration | ≤ 6,000 particles per container | 1,420 particles per container | ✓ P |
Particulate Matter — Subvisible (≥ 25 µm) USP <788> · light obscuration | ≤ 600 particles per container | 84 particles per container | ✓ P |
Container Integrity USP <1207> · dye-ingress | No dye penetration detected | PASS — no dye penetration in 20-sample audit | ✓ P |
Tamper-Evident Closure Visual inspection · 100 % AQL 0.65 | Aluminum crimp seal intact, rubber septum self-sealing | PASS — 100 % conform | ✓ P |
§ 4 — Conclusion & Release Authorization
Lot 25-1042-A of Bacteriostatic Water for Injection, USP has been release-tested per the specifications above and is hereby RELEASED for distribution. All test results conform to United States Pharmacopeia (USP) and label specifications. This record is maintained as a controlled quality document under the BAC Water Depot release-record system.
Released By
Quality Assurance · Release Authority
BAC Water Depot
Release Date
2026-04-22
YYYY-MM-DD · ISO 8601
