| Test Items | Limit | Result |
|---|---|---|
| Appearance | white or almost white crystalline powder or colorless crystals | conform |
| Identification | as per USP33 | conform |
| Specific rotation | +26.3º to +27.7º | +27.4º |
| Loss on drying | not more than 0.5% | 0.2% |
| Residue on ignition | not more than 0.3% | 0.05% |
| Chloride | not more than 0.05% | <0.05% |
| Sulfate | not more than 0.03% | <0.03% |
| Iron | not more than 0.003% | <0.003% |
| Heavy metals | not more than 0.0015% | <0.0015% |
| Lead | not more than 3ppm | <3ppm |
| Cadmium | not more than 1ppm | <1ppm |
| Arsenic | not more than 1ppm | <1ppm |
| Mercury | not more than 0.1ppm | <0.1ppm |
| Chromatographic purity | as per USP33 | conform |
| Assay | 98.5% to 101.5% | 99.7% |
| Total Plate Count | not more than 1000cfu/g | <1000cfu/g |
| Yeast & Mold | not more than 100cfu/g | <100cfu/g |
| E.coli | Negative/1g | conform |
| Salmonella | Negative/10g | conform |
| Staphylococcus aureus | Negative/1g | conform |
| Test Items | Limit | Result |
|---|---|---|
| Appearance | white or almost white crystalline powder or colorless crystals | conform |
| Identification | as per USP33 | conform |
| Specific rotation | +26.3º to +27.7º | +27.4º |
| Loss on drying | not more than 0.5% | 0.2% |
| Residue on ignition | not more than 0.3% | 0.05% |
| Chloride | not more than 0.05% | <0.05% |
| Sulfate | not more than 0.03% | <0.03% |
| Iron | not more than 0.003% | <0.003% |
| Heavy metals | not more than 0.0015% | <0.0015% |
| Lead | not more than 3ppm | <3ppm |
| Cadmium | not more than 1ppm | <1ppm |
| Arsenic | not more than 1ppm | <1ppm |
| Mercury | not more than 0.1ppm | <0.1ppm |
| Chromatographic purity | as per USP33 | conform |
| Assay | 98.5% to 101.5% | 99.7% |
| Total Plate Count | not more than 1000cfu/g | <1000cfu/g |
| Yeast & Mold | not more than 100cfu/g | <100cfu/g |
| E.coli | Negative/1g | conform |
| Salmonella | Negative/10g | conform |
| Staphylococcus aureus | Negative/1g | conform |
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