CASR |
: | ------ |
Molecular Formula |
: | ------ |
Molecular Weight |
: | ------ |
| Specifications | |
|---|---|
| Description: | Colourless crystals or a white powder; slightly hygroscopic in moist air.(Note: The product may cause lumps or hardening over the storage). |
| Solubility: | Very soluble in water, freely soluble in ethanol (95%), sparingly soluble in ether. |
| Identification A (By IR): | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard |
| Identification B (By Chemical test): | A white precipitate soluble in 6M acetic acid should produce. |
| Identification C (By Chemical test): | A 10.0% w/v solution is strongly acidic. |
| Appearance of Solution: | The solution is clear and not more intensely coloured than reference solution YS7, BYS7 or GY7. |
| Arsenic (As): | NMT 1ppm |
| Barium(Ba): | Any opalescence produced is not more intense than that of mixture of 5ml of solution A and 5ml of distilled water. |
| Calcium (Ca): | NMT 200ppm |
| Heavy metals: | NMT 10ppm |
| Iron (Fe): | NMT 50ppm |
| Chlorides: | NMT 50ppm |
| Sulphate (SO4): | NMT 150ppm |
| Oxalic acid: | 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. |
| Readily carbonizable substances: | Any colour produced is not more intense than that of a mixture of 1.0 ml of CCS and 9.0 ml of FCS. |
| Sulphated ash: | NMT 0.1% |
| Water: | NMT 1.0% |
| Assay (Anhydrous basis): | Not less than 99.0% and Not more than 101.0% |
| Total aerobic microbial count: | NMT 100 CFU/gm |
| Total combined yeast and molds count: | NMT 10 CFU/gm |
| E.coli: | Should be absent/gm |
| Pseud. aeruginosa: | Should be absent/gm |
| Staphylococcus aureus: | Should be absent/gm |
| Bile-tolerant gram negative bacteria: | Should be absent/gm |
| Bacterial endotoxins: | NMT 0.5 EU/mg |
