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Audited Supplier | Test | Specification | Result |
| Characteristic | A white or off white crystalline powder | Complies |
| Melting Point | 104ºC~110ºC | 107ºC~109ºC |
| Specific Rotation | +21°~+27° | +25.1° |
| Identification | (1) Positive (2) Positve (3) Spectrum conforms to Reference Standard |
Complies Complies Complies |
| Check | ||
| pH | 1.5~2.5 | 1.8 |
| Clarification and color of solution | Clear and colorless | Complies |
| Related Substances | ||
| L-cysteine | ≤0.5% | ≤0.1% |
| L-cystine | ≤0.5% | not detected |
| Any other unspecified impurity | ≤0.5% | 0.1% |
| Total impurites | ≤1.0% | 0.2% |
| Loss on Drying | ≤1.0% | 0.05% |
| Residue on Ignition | ≤0.1% | 0.04% |
| Heavy Metals | ≤10ppm | <10ppm |
| Chloroform | ≤0.006% | not detected |
| Assay | 98.0% ~102.0% | 100.5% |
| Conclusion: this batch meets the specification of CP2015 | ||
| Item | Specification | Result |
| Appearance | White crystals or crystalline powder | Conforms |
| Solubility (H2O, g/100g): | 17(20°),80(40°),260(60°) | Conforms |
| Specific rotation[a]D20° | +21.3°~+27.0° | +24.0° |
| State of solution | ≥98.0% | 98.5% |
| Chloride(Cl) | ≤0.04% | 0.02% |
| Ammonium(NH4) | ≤0.02% | 0.01% |
| Sulfate(SO4) | ≤0.03% | 0.010% |
| Iron(Fe) | ≤20PPm | 4PPm |
| Arsenic(As2O3) | ≤1PPm | 0.5PPm |
| Heavy metals(Pb) | ≤15PPm | 6PPm |
| Loss on drying | ≤0.5% | 0.3% |
| Organic volatile impurities | Meets the requirements | Conforms |
| Residue on ignition (Sulfated) | ≤0.30% | Conforms |
| Assay | 98.5~101.0% | Conforms |
| PH | 2.0~2.8 | 2.45 |
| 60Mesh | NMT 50% | Conforms |
| 100Mesh | NMT 40% | Conforms |
| Packing: 25KG NET DRUM Storage condition: Store in a cool, dry and well-ventilated area. Keep away from heat, sparks and flames. Shelf life: This product is stable for at least two years in the unopened original package. It is recommended to use the entire contents after opening. |
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Suppliers with verified business licenses
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