1 | Description | Clear, colorless, volatile liquid. | A crystalline mass or clear, colorless, volatile liquid. |
2 | Solubility | Complies | Miscible with water, with ethanol (96%) with methylene chloride with ether. |
3 | Identification A (By Chemical test) | Complies | A 10% w/v solution should be strongly acidic. |
4 | Identification B (By Chemical test) | Complies | Blue precipitate or dark blue color should produce. |
5 | Freezing point | 16.0°C | NLT 14.8° C |
6 | Residue on evaporation | 0.0015% | NMT 0.01% |
7 | Reducing substances 1 | Complies | NLT 1.0 ml of 0.1M sodium thiosulphate should require. |
8 | Reducing substances 2 | Complies | The color of solution should remain pink. |
9 | Heavy metals | Less than 5 ppm | NMT 5 ppm |
10 | Iron (Fe) | Less than 5 ppm | NMT 5 ppm |
11 | Chloride (Cl) | Less than 25 ppm | NMT 25 ppm |
12 | Sulphate (SO4) | Less than 50 ppm | NMT 50 ppm |
13 | Assay | 99.8% | 99.0% w/w to 100.5% w/w. |
14 | Total aerobic microbial count | Less than 100 CFU/mL | NMT 100 CFU/mL |
15 | Total Yeast and mold count | Less than 100 CFU/mL | NMT 100 CFU/mL |
16 | Escherichia coli | Absent/mL | Should be Absent /mL |
17 | Pseud. aeruginosa | Absent/mL | Should be Absent /mL |
18 | Staphylococcus aureus | Absent/mL | Should be Absent /mL |
19 | Bile-tolerant gram negative bacteria | Absent/mL | Should be Absent /mL |
20 | Bacterial endotoxin test | Less than 0.5 EU/mg | NMT 0.5 EU/mg |