CASR |
: | 6106-24-7 |
Molecular Formula |
: | C4H4O6Na2.2H2O |
Molecular Weight |
: | 230.08 |
| Specifications | |
|---|---|
| Description: | Transparent, colorless, odourless crystals. |
| Solubility: | Freely soluble in water; insoluble in alcohol. |
| Identification A (Sodium): | A dense precipitate should form. |
| Identification B (Tartrate): | Reddish pink color should produce within 15 min. |
| Assay (on dried basis): | 99.0%-100.5% |
| pH (10% aq soln): | 7 - 9 |
| Loss on drying, 150°C for 3 Hr.: | 14.0% - 17.0% w/w |
| Specific optical rotation: | + 29.5° to + 31.5° |
| Clarity and colour of solution: | Any colour produced is not more intense than that of reference solution Y2. |
| chloride: | NMT 0.002% |
| Sulfate: | NMT 0.005% |
| Iron: | NMT 0.001% |
| Heavy metals: | NMT 0.002% |
| Total aerobic microbial count: | NMT 100 CFU/gm |
| Total combined yeast and molds count: | NMT 10 CFU/gm |
| Staphylococcus aureus: | should be absent/gm |
| Pseudomonas aeruginosa: | should be absent/gm |
| Bacterial endotoxins: | NMT 2.5 EU/gm (For injectable grade only) |
