1 | Appearance/Description | White crystalline powder. | White crystalline powder or colorless crystals or scales, or needles |
2 | Solubility | Complies | Slightly soluble in water, soluble in boiling water, freely soluble in ethanol (96%) chloroform, ether and in fatty oils. |
3 | Identification(By Melting point) | 122°C | 121°C to 124°C |
4 | Identification (Benzoates) | Complies | A dull-yellow precipitate, soluble in ether should form. |
5 | Identification (By chemical test 1) | Complies | A salmon-colored precipitate should form |
6 | Identification (By chemical test 2) | Complies | A white precipitate should form in 10 min, soluble in ether. |
7 | Appearance of Solution | Complies | Clear and colorless solution. |
8 | Carbonisable substances/Readily carbonizable substances | Complies | The solution is not more intensely colored than reference solution Y5 or matching fluid Q. |
9 | Oxidisable substances | Complies | The solution is still colored pink. |
10 | Readily oxidizable substances | Complies | NMT 0.50ml of 0.10N Potassium permanganate should consume |
11 | Halogenated compounds and halides | Less than 300ppm | NMT 300ppm |
12 | Sulphated ash / Residue on ignition | 0.03% | NMT 0.05% |
13 | Assay | 99.8% | 99.0% - 100.5% |
14 | Assay (anhydrous basis) | 99.8% | 99.5% - 100.5% |
15 | Congealing temperature | 122°C | 121° - 123° |
16 | Water | 0.12% | NMT 0.7% |
17 | Total aerobic bacterial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
18 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
19 | Pseud. aeruginosa | Absent/gm | Should be Absent/gm |
20 | Staphylococcus aureus | Absent/gm | Should be Absent/gm |
21 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |