Original file on request
Example data · not a real lot
Sterile Water 10 mL
- Lot
- EXAMPLE-SW10-2608
- 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) |
| Identification | FTIR | Infrared absorption spectrum concordant with that of the reference standard | Conforms (example) |
| Conductivity / Total organic carbon | USP <645> conductivity; USP <643> TOC | Conductivity NMT 1.3 µS/cm at 25 °C; TOC NMT 500 ppb | 0.8 µS/cm; TOC 120 ppb (example) |
| pH | Potentiometry (USP <791>) | 5.0 – 7.0 | 6.0 (example) |
| Elemental Impurities (ICH Q3D / USP <232>, <233>) | 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 ppm (ICH Q3D, parenteral); Cu NMT 5.0 ppm. Additional house requirement: Σ of Class 1 + Class 2A (Cd, Pb, As, Hg, Co, V, Ni) < 4.0 ppm | All elements below limits (example) |
| Particulate matter | Light obscuration (USP <788> Method 1); visible: USP <790> | NMT 6000 particles ≥10 µm and NMT 600 ≥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 (USP <85>) | < 0.10 EU/mL (example) |
| Sterility | USP <71>, membrane filtration; method suitability performed | Sterile — no growth (USP <71>) | No growth (14 days) (example) |
| Fill volume (gravimetric) | Gravimetric, density-corrected | 10.00 mL/vial ± 5.0% | 10.08 mL (example) |
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