1 | Description | White powder; slightly hygroscopic in moist air. | Colourless crystals or a white powder; slightly hygroscopic in moist air. |
2 | Solubility | Complies | Very soluble in water, freely soluble in ethanol (95%), sparingly soluble in ether. |
3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard |
4 | Identification B (By Chemical test) | Complies | It gives reaction (A) of citrates. |
5 | Identification C (By Chemical test) | Complies | A 10.0% w/v solution is strongly acidic. |
6 | Appearance of Solution | Complies | The solution is clear and not more intensely coloured than reference solution YS7, BYS7 or GY7. |
7 | Arsenic (As) | Less than 1ppm | 1ppm max |
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. |
9 | Calcium (Ca) | Less than 200ppm | NMT 200ppm |
10 | Heavy metals | Less than 10ppm | NMT 10ppm |
11 | Iron (Fe) | Less than 50ppm | NMT 50ppm |
12 | Chlorides | Less than 50ppm | NMT 50ppm |
13 | Sulphate (SO4) | Less than 150ppm | NMT 150ppm |
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. |
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. |
16 | Sulphated ash | 0.04% | NMT 0.1% |
17 | Water | 0.2% | NMT 1.0% |
18 | Assay (Anhydrous basis) | 99.8% | Not less than 99.0% and Not more than 101.0% |
19 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
20 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
21 | E.coli | Absent/gm | Must be absent per gram |
22 | Pseud. aeruginosa | Absent/gm | Should be absent/gm |
23 | Staphylococcus aureus | Absent/gm | Should be absent/gm |
24 | Bile-tolerant gram negative bacteria | Absent/gm | Should be absent/gm |
25 | Bacterial endotoxins | Less than 0.5 EU/mg | NMT 0.5 EU/mg |