| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Batch No. | HF170912 | Quantity | 9.8kgs |
| Mfg. Date | Sep. 12, 2017 | Package | As required |
| Rep. Date | Sep. 15, 2017 | Exp. Date | Sep. 11, 2019 |
| Items | Standards | Results | |
| Appearance | White to brownish yellow hygroscopic powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
Solubility |
Highly soluble in water, the highest solubility in organic solvents is in DMSO ,other organic solvents solubility is less than 1 mg/ml. Highly soluble in aqueous buffer media with a pH of less than 6 and solubility of afatinib dimaleate is pH-dependent | Complies | |
| Loss on Drying | ≤ 0.50% | 0.46% | |
| Residue on Ignition | ≤ 0.10% | 0.07% | |
| Heavy Metals | ≤ 20ppm | Complies | |
| Related Substances | Any single impurity: ≤0.50% | 0.42% | |
| Total impurities: ≤1.00 % | 0.86% | ||
| Assay | 99.0%~101.0% on anhydrous basis | 99.55% | |
| Reference Standard | In-house Standard | ||
| Conclusion | The product complied to In-house standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
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