| Customization: | Available |
|---|---|
| Certification: | GMP, FDA, ISO |
| Grade Standard: | Medicine Grade |
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| Items | Standards | Results |
| Characteristics | Off-white to pale yellow powder or crystalline powder, odorless,hygroscopicity. | Off-white crystalline powder, odorless, hygroscopicity |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| By Sulfate and Acetate | Complies | |
| Solubility | Soluble in the formamide and mixed solution of formamide - methanol(1: 1), slightly soluble in dimethyl sulfoxide, slightly soluble in water. In methanol, N, N dimethyl formamide, theproduct is very slightly dissolved. Almost insoluble in acetonitrile, acetone. | Complies |
| The Clarity and Color of the Solution | Solution should be clear and colorless. If color appears, it cannot be darker when comparing with yellow or yellow-green 4# standard colorimetric solution | Complies |
| Specific Rotation | -114°~-126° | -118.2° |
| Acidity | 2.0~3.0 | 2.51 |
| Water Content | 1.5%~3.0% | 2.72% |
| Heavy Metals | ≤ 20ppm | Complies |
| Sulfate | ≤ 1.00% | 0.02% |
| Acetate | 7.1%~8.7% | 8.18% |
| Residual Solvents | Methanol: ≤3000ppm | 270ppm |
| Ethanol: ≤5000ppm | ND | |
| Acetone: ≤5000ppm | ND | |
| Acetonitrile: ≤410ppm | 20ppm | |
| Dichloromethane: ≤600ppm | 10ppm | |
| Ethyl Acetate: ≤5000ppm | ND | |
| Tetrahydrofuran: ≤880ppm | ND | |
| Hexamethyldisiloxane: ≤1000ppm | ND | |
| Pyridine: ≤200ppm | ND | |
| N,N-Dimethylacetamide: ≤1090ppm | ND | |
| Related Substances | Impurity A: ≤0.40% | 0.04% |
| Impurity B: ≤0.30% | 0.02% | |
| Impurity C: ≤4.00% | 0.46% | |
| Impurity D: ≤0.15% | ND | |
| Impurity E: ≤0.15% | ND | |
| Impurity F: ≤0.30% | ND | |
| Impurity G: ≤0.15% | ND | |
| Impurity H: ≤0.15% | ND | |
| Impurity I: ≤0.60% | 0.09% | |
| Largest Single impurity: ≤0.10% | 0.08% | |
| Total Impurities: ≤5.00% | 0.72% | |
| Acetamide | ≤0.10% | ND |
| Imidazole | ≤0.10% | ND |
| Polymer | ≤0.50% | 0.32% |
| Bacterial Endotoxin | The amount of endotoxin per 1mg should be less than 0.05EU |
Complies |
| Microbial Limits | Total Aerobic Count: ≤ 100CFU/gram | Complies |
| Salmonella Species: Negative | Complies | |
| Escherichia Coli: Negative | Complies | |
| Assay | 95.0%~102.0% (Calculated as anhydrous without acetic acid) |
99.21% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers, stored at low temperature (2ºC to 6ºC) and protect from light |
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