China 99% Assay High Purity Ketotifen Fumarate Pharmaceutical Chemical Powder with CAS 34580-14-8, Find details about China API Ketotifen Fumarate, Pharmaceutical from 99% Assay High Purity Ketotifen Fumarate Pharmaceutical Chemical Powder with CAS 34580-14-8
Batch No. | HF160415 | Quantity | 48.6kgs |
Mfg. Date | Apr. 15, 2016 | Package | As required |
Rep. Date | Apr. 18, 2016 | Exp. Date | Apr. 14, 2018 |
Items | Standards | Results | |
Appearance | White to brownish-yellow,fine,crystalline powder | Complies | |
Identification | By IR | Complies | |
By HPLC | |||
Solubility | Sparingly soluble in Water,slightly soluble in Methanol,very slightly soluble in Aceton | Complies | |
Clarity and Color of Solution | Clear and not more than Y4BY4B4 | < BY4 | |
Loss on Drying | ≤ 0.50% | 0.20% | |
Sulfated Ash | ≤ 0.10% | 0.05% | |
Related Substances | Impurity A: ≤0.20% | 0.06% | |
Impurity G: ≤0.20% | ND | ||
Single unknown impurity: ≤0.10% | Complies | ||
Total Impurities: ≤0.50% | 0.13% | ||
Assay (HPLC basis on drying) | 98.5%~101.0% | 99.83% | |
Reference Standard | EP7.0 Standard | ||
Conclusion | The product complied to EP7.0 standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |