| Function: | Pharmaceutical Medicine |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
| Type: | Chemicals |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
| Customization: |
|---|
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| Items | Standards | Results |
| Appearance | White to off-white powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Slightly soluble in Ethyl Acetate and Acetonitrile and very slightly soluble in Water. | Complies |
| Water Content | ≤ 1.00% | 0.37% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 1.00% | 0.48% |
| Residual Solvents | Ethanol: ≤5000ppm | ND |
| Dichloromethane ≤600ppm | ND | |
| Pyridine: ≤200ppm | ND | |
| Triethylamine: ≤320ppm | ND | |
| Isopropyl Acetate: ≤5000ppm | ND | |
| Methanol: ≤3000ppm | ND | |
| Isopropanol: ≤5000ppm | 500ppm | |
| Dimethyl sulfoxide: ≤5000ppm | ND | |
| Related Substances | Individual Impurity: ≤0.10% | 0.01% |
| Total Impurities: ≤1.00% | 0.02% | |
| Enantiomer Purity | ≤ 0.10% | 0.01% |
| L-Pyroglutamic Acid Assay | 22.1%~24.5% (As C5H7NO3, calculated on anhydrous basis) |
24.6% |
| Assay | 98.0%~102.0% (As C22H25ClO7, calculated on anhydrous basis) |
99.98% |
| 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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