Specification | ||
Test Item | Specification | Test Method |
Appearance | White crystals or crystalline powder | Visual |
Identification infrared absorption | Meets the requirements | USP24 |
Assay | 98.5%~101.5% | USP24 |
Particle size | 90% pass through 80 mesh | In-house |
pH | 5.5~7.0 | USP24 |
Loss on drying | Maximum 0.3% | USP24 |
Residue on ignition | Maximum 0.1% | USP24 |
Specific rotation[a]D20 | +26.6°~+28.8° | USP24 |
Organic volatile impurities | Meets the requirements | USP24 |
Iron | Maximum 30ppm | USP24 |
Chloride | Maximum 0.05% | USP24 |
Heavy Metals | Maximum 15ppm | USP24 |
Sulfate | Maximum 0.03% | USP24 |
Arsenic | Maximum 1.5ppm | USP24 |
Total Plate count (cfu/g) | Maximum 1000 cfu/g | In-house |
Moulds and yeast | Maximum 100 cfu/g | In-house |
Escherichia coli | Negative | In-house |
Salmonella | Negative | In-house |