1 | Description | White, odorless, tasteless, crystalline powder. | White, odorless ,tasteless crystalline powder. |
2 | Solubility | Complies | Freely soluble in dilute hydrochloric acid or dilute nitric acid; slightly soluble in boiling water; very slightly soluble in cold water; insoluble in ethanol, ether, or chloroform. |
3 | Identification A (Calcium) | Complies | A white precipitate, which is insoluble in 6N acetic acid but soluble in hydrochloric acid should form. |
4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
5 | Assay | 99.8% | 99.0% w/w - 101.0% w/w |
6 | Chloride (Cl) | Less than 0.07% | NMT 0.07% |
7 | Sulfate | Less than 0.12% | NMT 0.12% |
8 | Sucrose and reducing sugars | Complies | No red precipitate should form immediately |
9 | Optical Rotation | +19.90° | +17.5° to + 21.5° |
10 | Heavy metals | Less than 10ppm | NMT 10ppm |
11 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm |
12 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
13 | E.coli | Absent/gm | should be absent/gm |
14 | Bacterial endotoxins | Less than 5 EU/gm | NMT 5 EU/gm (For in-house control only, not for release & shelf life) |