Example data · not a real lot
Bacteriostatic Water 10 mL
- Lot
- EXAMPLE-BW10-2608
- Manufactured
- 2026-08
- Expiry
- 2028-08
- Container
- Clear glass vial · grey butyl rubber stopper · aluminium flip-off seal
| Check | This lot | Pass mark |
|---|---|---|
| Appearance | Conforms (example) | Clear, colorless solution |
| Water and benzyl-alcohol component identity | Conforms (example) | Water grade conforms to the released specification and the preservative is identified as benzyl alcohol; component identity does not by itself establish concentration, sterility or finished-product status |
| Benzyl alcohol content | 0.91% v/v (example) | 0.9% ± 0.1% (v/v) |
| pH | 5.8 (example) | 5.0–7.0 |
| Elemental impurities | All elements below limits (example) | Cd NMT 0.2; Pb 0.5; As 1.0; Hg 0.3; Co 0.5; V 1.0; Ni 2.0; Li 5.0; Sb 1.0; Cu 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm |
| Antimicrobial effectiveness | Meets Category 1 criteria (example) | Meets USP <51> Category 1 criteria for the tested released formulation; this result does not sterilize a contaminated vial or replace aseptic controls |
| Fill volume | 10.08 mL (example) | 10.00 mL/vial ±3.0% |
| Particulate matter | ≥10 µm: 120 / container; ≥25 µm: 8 / container (example) | NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates |
| Bacterial endotoxins | < 0.10 EU/mL (example) | NMT 0.25 EU/mL |
| Sterility | No growth (14 days) (example) | Sterile — no growth |
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