Sr. No. | TEST | SPECIFICATION | REFERENCE |
1. | Description | White or almost white, hygroscopic, crystalline powder | USP |
2. | Solubility | Soluble in water; practically insoluble in anhydrous ethanol | USP |
3. | Identification | (A) zinc ion test (B) Gluconate ion test | USP |
4. | Impurities :- | (1) CHLORIDE – NMT 500ppm (2) SULFATE – NMT 500ppm (3) ARSENIC – NMT 3 ppm (4) LEAD – NMT 10 ppm (5) CADMIUM – NMT 5 ppm (6) REDUCING SUBSTANCES – NMT 1.0% | USP |
5. | Water determination | NMT 11.6% | USP |
6. | pH | 5.5 to 7.5 | USP |
7. | Assay(On Dry Basis) | NLT 97.0% & NMT 102.0% | USP |