Example data · not a real lot
0.6% Acetic Acid Water 10 mL
- Lot
- EXAMPLE-AA10-2608
- Manufactured
- 2026-08
- Expiry
- 2028-08
- Container
- Clear glass vial · grey butyl rubber stopper · aluminium flip-off seal
| Test | Method | Specification | Result |
|---|---|---|---|
| Appearance | Visual examination against the stated description | Clear, colorless solution | Conforms (example) |
| Acetic acid identity | FTIR compared with a qualified acetic-acid reference standard | Infrared absorption spectrum concordant with that of the reference standard | Conforms (example) |
| Acetic acid content | Titration with 0.1 N NaOH, potentiometric endpoint (USP <541>) | 0.57%–0.63% (v/v) | 0.60% v/v (example) |
| pH | Potentiometry (USP <791>) | 2.7–3.1 | 2.9 (example) |
| Elemental impurities | ICP-MS (USP <233>), closed-vessel microwave digestion | Cd NMT 0.2; Pb NMT 0.5; As NMT 1.0; Hg NMT 0.3; Co NMT 0.5; V NMT 1.0; Ni NMT 2.0; Li NMT 5.0; Sb NMT 1.0; Cu NMT 5.0 ppm; sum of Cd, Pb, As, Hg, Co, V and Ni <4.0 ppm | All elements below limits (example) |
| Fill volume | Gravimetric, density-corrected | 10.00 mL/vial ±5.0% | 10.08 mL (example) |
| Particulate matter | Light obscuration (USP <788> Method 1); visible particles: USP <790> | NMT 6000 particles ≥10 µm and NMT 600 particles ≥25 µm per container; essentially free from visible particulates | ≥10 µm: 120 / container; ≥25 µm: 8 / container (example) |
| Bacterial endotoxins | Kinetic chromogenic LAL (USP <85>) | NMT 0.25 EU/mL | < 0.10 EU/mL (example) |
| Sterility | USP <71>, membrane filtration; method suitability performed | Sterile — no growth | No growth (14 days) (example) |
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