Certificate of Analysis – Renew Lab Group Bacteriostatic Water
Every batch of bacteriostatic water produced by Renew Lab Group ships with a complete, batch-specific Certificate of Analysis (COA). Our COAs document the results of six critical quality tests performed on the actual batch you receive — not a representative or historical sample. Below is the COA for our current batch.
Current Batch COA — Batch No. BAC-26041201
| Test Parameter | Specification | Result | Status |
|---|---|---|---|
| Product Name | Bacteriostatic Water for Injection | Bacteriostatic Water for Injection | PASS |
| Batch Number | — | BAC-26041201 | — |
| Manufacturing Date | — | April 12, 2026 | — |
| Expiration Date | — | April 12, 2028 | — |
| Benzyl Alcohol Concentration | 0.9% w/v (USP) | 0.91% w/v | PASS |
| pH | 4.5 – 7.0 | 5.8 | PASS |
| Endotoxin (LAL Method) | < 0.5 EU/mL | < 0.1 EU/mL | PASS |
| Sterility (USP <71>) | No growth | No growth detected | PASS |
| Appearance | Clear, colorless solution | Clear, colorless | PASS |
| Particulate Matter | USP <788> compliant | Compliant | PASS |
Testing Method: Benzyl alcohol by HPLC; Endotoxin by chromogenic LAL; Sterility per USP <71>; pH by calibrated electrode; Particulate matter per USP <788>.
Quality Control Signatory: Renew Lab Group QC Department, Houston, TX
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How to Read Our COA
Benzyl Alcohol Concentration
The 0.9% benzyl alcohol specification is the critical functional parameter for bacteriostatic water. This concentration is effective against a broad spectrum of Gram-positive and Gram-negative bacteria while remaining within the safe range for research applications. Our HPLC method measures this value to within ±0.05% accuracy. Batch BAC-26041201 measured 0.91% — within specification and consistent with our target of 0.90%.
Endotoxin Testing
Our endotoxin results of <0.1 EU/mL represent a greater-than-5× safety margin below the USP Bacteriostatic Water for Injection limit of 0.5 EU/mL. We use quantitative chromogenic LAL methodology rather than gel-clot pass/fail testing, giving you an actual measured value rather than a simple pass/fail determination. This is especially important for compounding pharmacy quality documentation.
Sterility Testing
Sterility is tested per USP <71> using both aerobic and anaerobic culture conditions with a minimum 14-day incubation period. No growth in either culture confirms the product is sterile at the time of testing. The benzyl alcohol preservative then maintains sterility through the product’s multi-dose use life.
pH
The pH of 5.8 is within the BWFI monograph specification range of 4.5–7.0 and is well within the optimal range for most peptide reconstitution applications. Most research peptides exhibit maximum stability at pH 5.5–6.5, making our product a compatible carrier.
COA for Compounding Pharmacies
Compounding pharmacies subject to USP <797> requirements need batch-specific COAs that document actual test values — not just pass/fail. Our standard COA format provides all values required for 503A and 503B quality documentation. Institutional customers can receive COAs in custom formats on request. For extended documentation packages including manufacturing environment data and method validation summaries, contact our institutional sales team.
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