1 | Description | White,fine, crystalline powder. Is odorless, has an acid taste, and stable in air. | Colorless or translucent crystals or white,fine granular,crystalline powder. Is odorless, has an acid taste, and stable in air. |
2 | Solubility | Complies | Very soluble in water; freely soluble in alcohol. |
3 | Identification A (By Chemical test) | Complies | Reddish pink color should produce within 15 min. |
4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
5 | Assay (Dried substance) | 99.8% | 99.7% - 100.5% |
6 | Residue on ignition | 0.009% | NMT 0.1% |
7 | Chloride & Sulfate: Sulfate | Complies | No turbidity is produced. |
8 | Specific optical rotation | +12.018° | +12.0° to +13.0° |
9 | Loss on drying | 0.2% | NMT 0.5% |
10 | Limit of Oxalate | Complies | No turbidity is produced. |
11 | Particle size | 90% passes through 60mesh | Min. 85% passthrough 60mesh |