| Customization: | Available |
|---|---|
| Function: | Dermatologic Agents |
| Certification: | GMP |
|
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| Batch No. | HF160618 | Quantity | 50kgs |
| Mfg. Date | Jun. 18, 2016 | Package | As required |
| Rep. Date | Jun. 21, 2016 | Exp. Date | Jun. 17, 2018 |
| Items | Standards | Results | |
| Characteristics | White or almost white powder | Almost white powder | |
| Identification | By IR | Complies | |
| Solubility | Practically insoluble in water and ethanol(96%),sparingly soluble in tetrahydrofuran. | Complies | |
| Appearance of Solution | The solution is clear and not more intensely coloured than reference solution BY6 | Complies | |
| Loss on Drying | ≤ 0.50% | 0.12% | |
| Heavy Metals | ≤ 20ppm | Complies | |
| Sulfated Ash | ≤ 0.10% | 0.07% | |
| Residual Solvents | Tetrahydrofuran: ≤720ppm | ND | |
| Triethylamine: ≤320ppm | ND | ||
| Microbiological Test | Aerobic Microorganism: ≤ 30 CFU/G | Complies | |
| Mould: ≤10 CFU/GR | Complies | ||
| Yeast: ≤10 CFU/GR | Complies | ||
| Pathogene | ND | ||
| Related Substances | Impurity A: ≤0.30% | 0.18% | |
| Impurity D: ≤0.20% | 0.14% | ||
| Impurity C: ≤0.15% | ND | ||
| Other unknown impurity: ≤0.10% | 0.07% | ||
| Total Impurities: ≤0.50% | 0.42% | ||
| Assay (HPLC basis on drying) |
98.0%~102.0% | 99.40% | |
| Reference Standard | EP8.0 Standard | ||
| Conclusion | The product complied to EP8.0 standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
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