| Powder: | Yes |
|---|---|
| Customized: | Non-Customized |
| Certification: | GMP, ISO 9001 |
| Suitable for: | Adult |
| State: | Solid |
| Purity: | >99% |
| Samples: |
|---|
| Customization: |
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Audited Supplier | Batch No. | HF180320 | Quantity | 30kgs |
| Mfg. Date | Mar. 20, 2018 | Package | As required |
| Rep. Date | Mar. 24, 2018 | Exp. Date | Apr. 19, 2019 |
| Items | Standards | Results | |
| Appearance | White or off-white powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Specific Optical Rotation | -105.0°~-110.0° | -107.6° | |
| Water Content | ≤ 2.00% | 0.60% | |
| Heavy Metals | ≤ 20ppm | Complies | |
| Residual on Ignition | ≤ 0.10% | 0.06% | |
| Residual Solvents | Acetonitrile ≤410ppm | ND | |
| Acetone ≤5000ppm | 615ppm | ||
| Methanol ≤3000ppm | ND | ||
| Dichloromethane ≤600ppm | ND | ||
| n-Heptane ≤5000ppm | 1271ppm | ||
| Related Substances | Impurity A: ≤0.50% | ND | |
| Impurity D: ≤0.50% | 0.24% | ||
| Impurity C: ≤0.15% | ND | ||
| Impurity D: ≤0.50% | 0.15% | ||
| Each of Unspecified impurity: ≤0.10% | 0.04% | ||
| Total Impurities: ≤1.00% | 0.44% | ||
| Assay (HPLC basis on drying) |
98.0%~102.0% | 99.20% | |
| Microbial Limit | Total Aerobic: ≤100cfu/g | <10cfu/g | |
| Total Yeasts and Molds: ≤100cfu/g | <10cfu/g | ||
| Staphylococcus Aureus: Absent | Absent | ||
| Pseudomonas Aeruginosa: Absent | Absent | ||
| PSD | D50: ≤ 40µm | 12.65µm | |
| D90: ≤ 100µm | 42.80µm | ||
| Reference Standard | In-house Standard | ||
| Conclusion | The product complied to In-house standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place,at temperature 2ºC~8ºC |
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