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DETAILS
FUNCTION
Application
COA| ITEMS | SPECIFICATION | RESULT | METHOD |
|---|---|---|---|
| Assay | 98.0%-102.0% (Calculated on the Dried Basis) | 99.1% | USP- ASSAY |
| Identification | Infrared Absorption | Conform | IR |
| Appearance | White crystals or crystalline powder | Conforms | Visual |
|---|---|---|---|
| Specific rotation [α]D25 | +21.0°to +27.0° | +23.0° | USP-781S |
| Loss on Drying | NMT 1.0% | 0.06% | USP-731 |
| Density | Bulk Density | 0.66mg/L | Weighing |
| Tap Density | 0.86mg/L | ||
| Residue on ignition | NMT 0.5% | 0.05% | USP-281 |
| pH | 2.0-2.8 | 2.2 | USP- 791 |
|---|---|---|---|
| Residual Solvents | Meets the requirements | Meets the requirements | USP |
| Heavy metals (Pb) | NMT 0.001% | USP-231 | |
| Arsenic(As2O3) | NMT 1ppm | AFS | |
| Lead | NMT 3ppm | AFS | |
| Cadmium (Cd) | NMT 1ppm | AFS | |
| Mercury | NMT 0.1ppm | AFS |
| Total Plate Count | NMT 1000cfu/g | Conforms | CP |
|---|---|---|---|
| Total Yeast & Mold | NMT 100cfu/g | Conforms | CP |
| Colifbrms | NMT 10cfu/g | Conforms | CP |
| E. Coli | Negative | Negative | CP |
| Salmonella | Negative | Negative | CP |
| S .Aureus | Negative | Negative | CP |
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