China API Oxaliplatin CAS 63121-00-6 Oxaliplatin, Find details about China Oxaliplatin, Oxaliplatin Powder from API Oxaliplatin CAS 63121-00-6 Oxaliplatin
CAS No.:63121-00-6
Name:Oxaliplatin
Place of Origin: China (Mainland)
Type: API
Grade Standard: Medicine Grade
Brand Name: guanlang
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(DriedSubstances) | 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 |