Busca Tratamiento De La Infección Intestinal, Tratamiento De úlceras Gastrointestinales, Tratamiento De Las úlceras Gastrointestinales Gmp en el directorio Industry, Reliable fabricante / proveedor / fábrica de China
| Tipo de Pago: | L/C, D/P |
|---|---|
| Cantidad de pedido mínima: | 1 Bag/Bags |
Modelo: USP
| Test Items | Specifications |
| Specific Rotation | -48° ~ -51.0°(on the anhydrous, solvent-free basis) |
| Identification | A.HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution. |
| B.IR: The IR spectrum of sample is consistent to the reference | |
| Related Substances | |
| Total impurity | Not more than 1.0% |
| Related Compound A | Not more than 0.2% |
| Related Compound B | Not more than 0.05% |
| Related Compound C | Not more than 0.05% |
| Related Compound D | Not more than 0.2% |
| Related Compound E | Not more than 0.2% |
| Formyl leucine | Not more than 0.2% |
| Orlistat open ring epimer | Not more than 0.2% |
| D-Leucine orlistat | Not more than 0.2% |
| Orlistat open ring amide | Not more than 0.1% |
| Individual unidentified impurity | Not more than 0.1% |
| Residual Solvents | |
| n-Hexane | Not more than 5000ppm |
| Isopropyl ether | Not more than 5000ppm |
| Residual on ignition | Not more than 0.1% |
| Heavy Metal | Not more than 20ppm |
| Water | Not more than 0.2% |
| Assay | 98.0%~101.5% (on the anhydrous, solvent-free basis) |
| Conclusion | Conform with USP35 |
Grupos de Producto : Ingrediente farmacéutico > Serie de Infección Gástrica e Intestinal
