| 1 | Description | Colourless crystals; slightly hygroscopic in moist air. | Colourless crystals or a white powder; slightly hygroscopic in moist air.(Note: The product may cause lumps or hardening over the storage). | IP |
| 2 | Solubility | Complies | Very soluble in water, freely soluble in ethanol (95%), sparingly soluble in ether. | IP |
| 3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard | IP |
| 4 | Identification B (By Chemical test) | Complies | A white precipitate soluble in 6M acetic acid should produce. | IP |
| 5 | Identification C (By Chemical test) | Complies | A 10.0% w/v solution is strongly acidic. | IP |
| 6 | Appearance of Solution | Complies | The solution is clear and not more intensely coloured than reference solution YS7, BYS7 or GY7. | IP |
| 7 | Arsenic (As) | Less than 1 ppm | NMT 1ppm | IP |
| 8 | Barium(Ba) | Complies | Any opalescence produced is not more intense than that of mixture of 5ml of solution A and 5ml of distilled water. | IP |
| 9 | Calcium (Ca) | Less than 200 ppm | NMT 200ppm | IP |
| 10 | Heavy metals | Less than 10 ppm | NMT 10ppm | IP |
| 11 | Iron (Fe) | Less than 50 ppm | NMT 50ppm | IP |
| 12 | Chlorides | Less than 50 ppm | NMT 50ppm | IP |
| 13 | Sulphate (SO4) | Less than 150 ppm | NMT 150ppm | IP |
| 14 | Oxalic acid | Complies | Any pink colour produced is not more intense than that produced by carrying out the test using 0.2mg of oxalic acid dissolved in 4ml of water. | IP |
| 15 | Readily carbonizable substances | Complies | Any colour produced is not more intense than that of a mixture of 1.0 ml of CCS and 9.0 ml of FCS. | IP |
| 16 | Sulphated ash | 0.04% | NMT 0.1% | IP |
| 17 | Water | 0.1% | NMT 1.0% | IP |
| 18 | Assay (Anhydrous basis) | 99.8% | Not less than 99.0% and Not more than 101.0% | IP |
| 19 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 20 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 21 | E.coli | Absent/gm | Should be absent/gm | In-house |
| 22 | Pseud. aeruginosa | Absent/gm | Should be absent/gm | In-house |
| 23 | Staphylococcus aureus | Absent/gm | Should be absent/gm | In-house |
| 24 | Bile-tolerant gram negative bacteria | Absent/gm | Should be absent/gm | In-house |
| 25 | Bacterial endotoxins | Less than 0.5 EU/mg | NMT 0.5 EU/mg | In-house |