Specification | ||
Test Item | Specification | Test Method |
Appearance | White crystals or crystalline powder | Visual |
Identification IR | Concordant with the reference spectrum | USP43 |
Assay | 98.5%~101.5% | USP43 |
Specific rotation[a]D20 | -9.8°~-11.2° | USP43 |
Loss on drying | Maximum 0.3% | USP43 |
Residue on ignition | Maximum 0.4% | USP43 |
Chloride | Maximum 0.04% | USP43 |
Sulfate | Maximum 0.04% | USP43 |
Chromatographic purity | USP43 | |
Individual impurity | Maximum 0.5% | |
Total impurities | Maximum 2.0% | |
Heavy Metals | Maximum 15ppm | In-house |
Iron | Maximum 30ppm | USP43 |
Total Plate count (cfu/g) | Maximum 1000 cfu/g | USP43 |
Moulds and yeast | Maximum 100 cfu/g | USP43 |
Escherichia coli | Negative | In-house |
Salmonella | Negative | In-house |