China 99% Assay High Purity Oxaliplatin Pharmaceutical Chemical Powder with CAS 63121-00-6, Find details about China API Oxaliplatin, Pharmaceutical from 99% Assay High Purity Oxaliplatin Pharmaceutical Chemical Powder with CAS 63121-00-6
Batch No. | HF160401 | Quantity | 5.6kgs |
Mfg. Date | Apr. 01, 2016 | Package | As required |
Rep. Date | Apr. 02, 2016 | Exp. Date | Mar. 31, 2018 |
Items | Standards | Results | |
Description | White or almost white crystalline powder | Complies | |
Solubility | Slightly soluble in water, very slightly soluble in methanol, practically insoluble in ethanol | Complies | |
Identification | IR vs standard | Complies | |
Test for specific optical rotation | Complies | ||
Appearance of Solution | The solution is clear and colourless | Complies | |
Acidity | Not more than 0.6 mL of 0.01M NaOH is required to change the colour of the indicator to pink | 0.46 mL | |
Specific Optical Rotation | +74.5°~+78.0° | +76.5° | |
Related Substances | Impurity A: ≤ 0.15% | 0.01% | |
Impurity B: ≤ 0.15% | 0.01% | ||
Impurity C: ≤ 0.15% | 0.001% | ||
Any other impurity: ≤ 0.10% | 0.007% | ||
Total of other impurities: ≤ 0.15% | 0.012% | ||
Total of impurities: ≤ 0.30% | 0.032% | ||
Impurity D | ≤ 0.15% | 0.02% | |
Solvents Residue | Ethanol: < 5000ppm | 110ppm | |
Silver | ≤ 5ppm | < 1ppm | |
Loss on Drying | ≤ 0.50% | 0.04% | |
Assay(Dried Substances) | 98.0% ~ 102.0% | 99.60% | |
Bacterial Endotoxins | ≤ 1.0 EU/mg | Complies | |
Reference Standard | EP 8.0 Standard | ||
Conclusion | The product complied to EP 8.0 standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |