Bacteriostatic Water
Certificate of Analysis · Lot PL-26082 · 3 ml
Sterile
Membrane filtration · LAL
Test results
6/6 conform| Test | Method | Specification | Result | |
|---|---|---|---|---|
| Appearance | Visual | Clear | Conforms | |
| Benzyl alcohol | GC-FID | 0.9 % (0.85 to 0.95 %) | 0.91 % | |
| pH value | Potentiometry | 4.5 to 7.0 | 5.6 | |
| Sterility | Membrane filtration | Sterile | Sterile | |
| Bacterial endotoxins | LAL | < 0.25 EU/ml | < 0.25 EU/ml | |
| Visible particles | Visual | None | None |
Methodology
GC-FID: gas chromatography with flame ionisation detector for determining the benzyl alcohol content against an external standard.
Sterility and endotoxins: membrane filtration and the limulus amebocyte lysate test, respectively.
Remarks
All parameters within specification. Batch released.
Sample report illustrating the report structure. Before market launch all reports will be replaced by test protocols from the accredited laboratory.