{
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  "generatedAt": "2026-10-16",
  "reportNo": "AN-2026-00018",
  "key": "6S6QH3RABS",
  "issued": "2026-08-11",
  "status": "issued",
  "sample": "Bacteriostatic water, 0.9 % benzyl alcohol, vial labelled 3 ml",
  "batch": "ATBAC-03-2607-01",
  "batchSlug": "atbac-03-2607-01",
  "matrix": "Bacteriostatic water for injection",
  "slug": "bakteriostaticka-voda",
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  "results": [
    {
      "determination": "Appearance",
      "method": "Visual, USP <790>, black and white background, 2000 lx, 5 s",
      "result": "Clear, colourless solution free of visible particles; faint aromatic odour of benzyl alcohol",
      "spec": "Clear, colourless, free of visible particles"
    },
    {
      "determination": "Identity of benzyl alcohol",
      "method": "GC-MS (EI, 70 eV) and LC-HRMS (ESI+)",
      "result": "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",
      "spec": "Theoretical monoisotopic 108.0575 Da from C7H8O; [M+H]+ 109.0648"
    },
    {
      "determination": "Benzyl alcohol content",
      "method": "GC-FID, DB-624, internal standard 2-phenylethanol; five-point calibration 0.5 to 1.5 % w/v, r² 0.9998",
      "result": "0.91 ± 0.02 % w/v (9.1 mg/ml), 101 % of the labelled 0.9 % (k = 2)",
      "spec": "90 to 110 % of label (0.81 to 0.99 % w/v)"
    },
    {
      "determination": "Related substances of benzyl alcohol",
      "method": "GC-FID; LOD 0.003 %, LOQ 0.01 %, reporting threshold 0.01 % relative to benzyl alcohol",
      "result": "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 %",
      "spec": "Ph. Eur. 0256, parenteral grade: benzaldehyde <= 0.05 %, cyclohexylmethanol <= 0.10 %, any other <= 0.10 %, total <= 0.3 %"
    },
    {
      "determination": "Deliverable volume",
      "method": "Gravimetric, USP <697>, density 0.9975 g/ml at 20 °C",
      "result": "3.15 ml (five vials 3.10 to 3.20 ml)",
      "spec": "Not less than 3.0 ml from each vial"
    },
    {
      "determination": "Benzyl alcohol per vial",
      "method": "Calculated from content and deliverable volume",
      "result": "28.7 mg per vial (9.1 mg/ml × 3.15 ml) against 27 mg for the labelled 0.9 % in 3 ml, i.e. 106 %; each withdrawn millilitre carries 9.1 mg regardless of overfill",
      "spec": "90 to 110 %"
    },
    {
      "determination": "pH",
      "method": "Potentiometric, USP <791>, 25 °C, KCl bridge for low ionic strength",
      "result": "5.6 ± 0.1",
      "spec": "4.5 to 7.0 (USP Bacteriostatic Water for Injection)"
    },
    {
      "determination": "Osmolality",
      "method": "Freezing point depression, USP <785>",
      "result": "85 ± 3 mOsm/kg (calculated 83 for 9.0 g/l benzyl alcohol); the solution is hypotonic and is not an isotonic vehicle",
      "spec": "Report only"
    },
    {
      "determination": "Conductivity",
      "method": "USP <645>, 25 °C",
      "result": "1.1 ± 0.1 µS/cm",
      "spec": "<= 1.3 µS/cm (stage 1)"
    },
    {
      "determination": "Total organic carbon",
      "method": "USP <643>",
      "result": "Not applicable: benzyl alcohol itself contributes 7.4 mg of carbon per ml, so the test would measure the preservative and not contamination",
      "spec": "Report only"
    },
    {
      "determination": "Density and balance",
      "method": "Oscillating U-tube, USP <841>, 20 °C",
      "result": "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)",
      "spec": "Report only"
    },
    {
      "determination": "Inorganic impurities of the water",
      "method": "Ion chromatography; oxidisable substances by permanganate",
      "result": "Nitrate < 0.2 ppm, chloride < 0.5 ppm, sulfate < 0.5 ppm, ammonium < 0.1 ppm; oxidisable substances: the pink colour persists",
      "spec": "Ph. Eur. Water for injections: nitrate <= 0.2 ppm, ammonium <= 0.2 ppm"
    },
    {
      "determination": "Bacterial endotoxins",
      "method": "Kinetic chromogenic LAL, USP <85>, undiluted sample",
      "result": "< 0.005 EU/ml (LOQ 0.005 EU/ml); 0.9 % benzyl alcohol does not interfere",
      "spec": "<= 0.25 EU/ml (USP Bacteriostatic Water for Injection)",
      "kind": "endotoxin"
    },
    {
      "determination": "Sterility",
      "method": "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",
      "result": "No growth after 14 days",
      "spec": "No growth",
      "kind": "sterility"
    },
    {
      "determination": "Antimicrobial effectiveness",
      "method": "USP <51>, category 1 (parenteral), inoculum 10^5 to 10^6 CFU/ml",
      "result": "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",
      "spec": "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"
    },
    {
      "determination": "Residual solvents and volatile impurities",
      "method": "Headspace GC, USP <467>",
      "result": "Benzene < 0.5 ppm (LOQ 0.5 ppm; precursor of benzyl alcohol); toluene < 1 ppm; methanol, ethanol and acetone each < 10 ppm",
      "spec": "ICH Q3C: benzene <= 2 ppm (Class 1), toluene <= 890 ppm, methanol <= 3000, ethanol and acetone <= 5000 ppm",
      "kind": "solvents"
    },
    {
      "determination": "Elemental impurities",
      "method": "ICP-MS, direct introduction of the solution, USP <233>",
      "result": "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",
      "spec": "ICH Q3D(R2) Class 1 and 2A, parenteral PDE per 3 ml daily: Cd 667, Pb 1667, As 5000, Hg 1000, Co 1667, V 3333, Ni 6667 µg/l"
    },
    {
      "determination": "Sub-visible particles",
      "method": "Light obscuration, USP <788>, mean of 5 vials",
      "result": ">= 10 µm 140 per vial; >= 25 µm 6 per vial",
      "spec": "<= 6000 and <= 600 per container"
    },
    {
      "determination": "Container closure integrity",
      "method": "Vacuum decay, USP <1207>",
      "result": "0 of 10 vials leaking; bromobutyl stopper, aluminium seal, flip-off cap",
      "spec": "0 leaking"
    },
    {
      "determination": "Compound screening",
      "method": "GC-MS full scan m/z 35 to 400 and LC-HRMS m/z 100 to 1000, both polarities, against reference standards",
      "result": "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",
      "spec": "Nothing above 1 µg/ml outside the declared composition",
      "kind": "screen"
    }
  ],
  "delivery": null,
  "controls": {
    "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",
    "referenceStandard": "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"
  }
}