1 | Description | Transparent, colorless, odourless crystals. | Transparent, colorless, odourless crystals. |
2 | Solubility | Complies | Freely soluble in water; insoluble in alcohol. |
3 | Identification A (Sodium) | Complies | A dense precipitate should form. |
4 | Identification B (Tartrate) | Complies | Reddish pink color should produce within 15 min. |
5 | Assay (on dried basis) | 99.2% | 99.0%-100.5% |
6 | pH (10% aq soln) | 7.92 | 7 - 9 |
7 | Loss on drying, 150°C for 3 Hr. | 15.5% | 14.0% - 17.0% w/w |
8 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
9 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
10 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm |