Verification · Certificates issued
Certificate AN-2026-00018
Valid
Issued
This certificate was issued by ANALYTON and has not been withdrawn.
Verification confirms that a certificate with this number and key was issued by ANALYTON on the date shown, for the sample described, and states its current status.
| Report number | AN-2026-00018 |
| Issued | 2026-08-11 |
| Status | Valid |
| Sample | Bacteriostatic water, 0.9 % benzyl alcohol, vial labelled 10 ml |
| Batch number | ATBAC-10-2607-01 |
| Matrix | Bacteriostatic water for injection |
| Determinations performed | 20 |
| Issued by | ANALYTON |
| Certificate file | AN-2026-00018.pdf |
01Results 20
| Determination | Method | Result | Specification |
|---|---|---|---|
| Appearance | Visual, USP <790>, black and white background, 2000 lx, 5 s | Clear, colourless solution free of visible particles; faint aromatic odour of benzyl alcohol | Clear, colourless, free of visible particles Pass |
| Identity of benzyl alcohol | GC-MS (EI, 70 eV) and LC-HRMS (ESI+) | Retention time 12.90 min matches the standard within 0.05 min; EI spectrum m/z 108 (M+•), 107, 79, 77, NIST library match 96 %; LC-HRMS [M+H]+ 109.0648, deviation 0.0 ppm, [M+Na]+ 131.047 | Theoretical monoisotopic 108.0575 Da from C7H8O; [M+H]+ 109.0648 Pass |
| Benzyl alcohol content | GC-FID, DB-624, internal standard 2-phenylethanol; five-point calibration 0.5 to 1.5 % w/v, r² 0.9998 | 0.91 ± 0.02 % w/v (9.1 mg/ml), 101 % of the labelled 0.9 % (k = 2) | 90 to 110 % of label (0.81 to 0.99 % w/v) Pass |
| Related substances of benzyl alcohol | GC-FID; LOD 0.003 %, LOQ 0.01 %, reporting threshold 0.01 % relative to benzyl alcohol | Benzaldehyde 0.030 % (RRT 0.85, ± 0.004 %), i.e. 2.7 µg/ml; dibenzyl ether 0.020 % (RRT 1.62); cyclohexylmethanol < 0.01 % (RRT 0.93); total 0.05 % | Ph. Eur. 0256, parenteral grade: benzaldehyde <= 0.05 %, cyclohexylmethanol <= 0.10 %, any other <= 0.10 %, total <= 0.3 % Pass |
| Deliverable volume | Gravimetric, USP <697>, density 0.9975 g/ml at 20 °C | 10.4 ml (five vials 10.3 to 10.5 ml) | Not less than 10.0 ml from each vial Pass |
| Benzyl alcohol per vial | Calculated from content and deliverable volume | 94.6 mg per vial (9.1 mg/ml × 10.4 ml) against 90 mg for the labelled 0.9 % in 10 ml, i.e. 105 %; each withdrawn millilitre carries 9.1 mg regardless of overfill | 90 to 110 % Pass |
| pH | Potentiometric, USP <791>, 25 °C, KCl bridge for low ionic strength | 5.6 ± 0.1 | 4.5 to 7.0 (USP Bacteriostatic Water for Injection) Pass |
| Osmolality | Freezing point depression, USP <785> | 85 ± 3 mOsm/kg (calculated 83 for 9.0 g/l benzyl alcohol); the solution is hypotonic and is not an isotonic vehicle | Report only |
| Conductivity | USP <645>, 25 °C | 1.1 ± 0.1 µS/cm | <= 1.3 µS/cm (stage 1) Pass |
| Total organic carbon | USP <643> | Not applicable: benzyl alcohol itself contributes 7.4 mg of carbon per ml, so the test would measure the preservative and not contamination | Report only |
| Density and balance | Oscillating U-tube, USP <841>, 20 °C | 0.9975 ± 0.0005 g/ml; 9.1 mg/ml benzyl alcohol + 988.4 mg/ml water = 997.5 mg/ml, consistent with the density; no other solute (conductivity 1.1 µS/cm) | Report only |
| Inorganic impurities of the water | Ion chromatography; oxidisable substances by permanganate | Nitrate < 0.2 ppm, chloride < 0.5 ppm, sulfate < 0.5 ppm, ammonium < 0.1 ppm; oxidisable substances: the pink colour persists | Ph. Eur. Water for injections: nitrate <= 0.2 ppm, ammonium <= 0.2 ppm Pass |
| Bacterial endotoxins | Kinetic chromogenic LAL, USP <85>, undiluted sample | < 0.005 EU/ml (LOQ 0.005 EU/ml); 0.9 % benzyl alcohol does not interfere | <= 0.25 EU/ml (USP Bacteriostatic Water for Injection) Pass |
| Sterility | Membrane filtration with 3 × 100 ml rinse to neutralise benzyl alcohol, USP <71>; 20 vials; fluid thioglycollate 30 to 35 °C and soya bean casein digest 20 to 25 °C | No growth after 14 days | No growth Pass |
| Antimicrobial effectiveness | USP <51>, category 1 (parenteral), inoculum 10^5 to 10^6 CFU/ml | S. aureus 3.4 log reduction at 7 d and > 4.0 at 14 d; P. aeruginosa 3.6 and > 4.0; E. coli 3.8 and > 4.0; C. albicans 1.2 log at 14 d; A. brasiliensis 0.6 log at 14 d; no increase to 28 d. Benzyl alcohol is weak against moulds, which is why the number is reported | Bacteria >= 1.0 log at 7 d, >= 3.0 log at 14 d, no increase to 28 d; yeast and mould no increase from the initial count Pass |
| Residual solvents and volatile impurities | Headspace GC, USP <467> | Benzene < 0.5 ppm (LOQ 0.5 ppm; precursor of benzyl alcohol); toluene < 1 ppm; methanol, ethanol and acetone each < 10 ppm | ICH Q3C: benzene <= 2 ppm (Class 1), toluene <= 890 ppm, methanol <= 3000, ethanol and acetone <= 5000 ppm Pass |
| Elemental impurities | ICP-MS, direct introduction of the solution, USP <233> | Cd, Pb < 0.05 µg/l; As, Hg, Co, V < 0.10 µg/l; Ni 0.30 µg/l; for information Al 2.0 µg/l (type I glass) and Fe 1.5 µg/l | ICH Q3D(R2) Class 1 and 2A, parenteral PDE per 10 ml daily: Cd 200, Pb 500, As 1500, Hg 300, Co 500, V 1000, Ni 2000 µg/l Pass |
| Sub-visible particles | Light obscuration, USP <788>, mean of 5 vials | >= 10 µm 140 per vial; >= 25 µm 6 per vial | <= 6000 and <= 600 per container Pass |
| Container closure integrity | Vacuum decay, USP <1207> | 0 of 10 vials leaking; bromobutyl stopper, aluminium seal, flip-off cap | 0 leaking Pass |
| Compound screening | GC-MS full scan m/z 35 to 400 and LC-HRMS m/z 100 to 1000, both polarities, against reference standards | Other preservatives (methylparaben, propylparaben, phenol, m-cresol, chlorobutanol), ethanol, glycerol, propylene glycol and phthalates (DEHP from the closure): none above 1 µg/ml; no sodium chloride (conductivity), so this is not saline | Nothing above 1 µg/ml outside the declared composition Pass |
02The sample and the run
| Blank | Water for injection with internal standard injected before the sequence; within RRT 0.80 to 1.30 no peak above 0.02 % of the benzyl alcohol height (maximum 0.004 %) apart from the internal standard |
| Reference standard | USP Benzyl Alcohol RS (primary) injected at the start and end of the sequence; area ratio difference 0.3 %, retention time within 0.05 min; a commercial USP bacteriostatic water run as control sample within 2 % of its previous value |
03Check your copy of the file
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A copy that has been re-saved, printed to a new file or passed through a converter will not match, because each of those produces a different file. Compare the certificate exactly as it was sent to you, or the copy downloadable from this page.
ca260d83b76b8d11c4dd032feb58231c2e7e325b9cd62052812ad821e1d9fee4
shasum -a 256 AN-2026-00018.pdf
On Windows: certutil -hashfile AN-2026-00018.pdf SHA256
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