| Customization: | Available |
|---|---|
| Function: | Pharmaceutical Medicine |
| Certification: | GMP, FDA, ISO |
|
Still deciding? Get samples of $ !
Request Sample
|
Suppliers with verified business licenses
Audited Supplier Audited by an independent third-party inspection agency
| Items | Standards | Results |
| Characteristics | A white to off-white crystalline powder | White crystalline powder |
| Identification | By IR | Complies |
| By UV | Complies | |
| By HPLC | Complies | |
| Identification of phosphate: Must be have positive reaction | Complies | |
| Solubility | It is freely soluble in ethanol, sparingly soluble in water at room temperature | Complies |
| Melting Point | 96ºC~100ºC | Complies |
| Color and Clarity | Must be colorless and clear | Complies |
| Water Content | ≤ 1.00% | 0.23% |
| Heavy Metals | ≤ 10ppm | Complies |
| Residual Solvents | Methanol: ≤3000ppm | ND |
| Dichloromethane: ≤600ppm | 200ppm | |
| Toluene: ≤890ppm | ND | |
| n-Hexane: ≤290ppm | ND | |
| Trichloromethane: ≤60ppm | ND | |
| Acetonitrile: ≤410ppm | ND | |
| N,N-Dimethylformamide ≤880ppm | ND | |
| Related Substances | Impurity Adefovir Mon-pivoxil: ≤1.00% | 0.80% |
| Impurity PMEA: ≤0.50% | ND | |
| Any other impurity: ≤0.50% | 0.11% | |
| Total impurities: ≤2.00% | 1.01% | |
| Assay (HPLC basis on drying) |
97.5%~102.0% | 98.80% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
){kind=link}