| Function: | Specialist Drugs |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Pharmaceutical |
| State: | Solid |
| Volatile: | Volatile |
| Samples: |
|---|
| Customization: |
|---|
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Certificate of Analysis
| Batch No. | HF171021 | Quantity | 2.08kgs |
| Mfg. Date | Oct. 21, 2017 | Package | As required |
| Rep. Date | Oct. 24, 2017 | Exp. Date | Oct. 20, 2019 |
| Items | Standards | Results | |
| Appearance | White or light yellow crystalline powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Solubility | Freely soluble in methylene chloride,sparingly soluble in methanol, soluble in ethyl acetate,Almost insoluble in water. | Complies | |
| Specific Rotation | +188°~+200° | +198° | |
| Loss on Drying | ≤ 0.50% | 0.23% | |
| Heavy Metals | ≤ 10ppm | Complies | |
| Residue on Ignition | ≤ 0.10% | 0.08% | |
| Residual Solvent | Methanol: ≤3000ppm | ND | |
| Isopropyl ether: ≤5000ppm | ND | ||
| THF: ≤720ppm | ND | ||
| Ethyl acetate: ≤5000ppm | 1500ppm | ||
| Isopropanol: ≤5000ppm | ND | ||
| Dichloromethane: ≤600ppm | 300ppm | ||
| Related Substances | Impurity A: ≤0.10% | 0.03% | |
| Maximum unknown single impurity: ≤0.10% | Complies | ||
| Total impurities: ≤1.00% | 0.20% | ||
| Assay | 98.0%~102.0% | 99.62% | |
| 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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