| Assay (m/m) |
92.6 - 95.2 % |
| Assay (V/V) |
95.1 - 96.9 % |
| Identity (IR) |
conforms |
| Appearance |
conforms |
| Acidity or alkalinity |
≤ 30 ppm |
| Density (d 20 °C/20 °C) |
0.805 - 0.812 |
| Absorbance (at 240 nm) |
≤ 0.40 |
| Absorbance (between 250nm and 260nm) |
≤ 0.30 |
| Absorbance (between 270nm and 340nm) |
≤ 0.10 |
| The spectrum shows a steadily descending curve with no observable peaks or shoulders |
conforms |
| Volatile impurities (GC) (Acetaldehyde and Acetal) |
≤ 10 ppm |
| Volatile impurities (GC) (Benzene) |
≤ 2 ppm |
| Volatile impurities (GC) (Methanol) |
≤ 200 ppm |
| Volatile impurities (GC) (Total of other impurities) |
≤ 300 ppm |
| Volatile impurities (GC) (disregard limit) |
≤ 9 ppm |
| Other residual solvents (ICH Q3C) |
excluded by production process |
| Evaporation residue |
≤ 25 mg/l |
| Bacterial endotoxins |
≤ 2.5 |
| Total aerobic microbial count (TAMC) |
≤ 100 |
| Total combined yeasts/moulds count (TYMC) |
≤ 10 |
| Bile-tolerant gram-negative bacteria (absent in 1 g) |
passes test |
| Candida albicans (absent in 1 g) |
passes test |
| Escherichia coli (absent in 1 g) |
passes test |
| Pseudomonas aeruginosa (absent in 1 g) |
passes test |
| Salmonella (absent in 10 g) |
passes test |
| Staphylococcus aureus (absent in 1 g) |
passes test |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). Conforms to Ph Eur, BP. |
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