China Manufacture Supply Lubiprostone Powder for Treating Chronic Idiopathic Constipation, Find details about China Lubiprostone, Pharmaceutical Chemical from Manufacture Supply Lubiprostone Powder for Treating Chronic Idiopathic Constipation
Product Name | Lubiprostone |
Identification | A.H-NMR: Comply with the structure B. LC-MS: Comply with the structure C.The IR spectrum of sample should be identical with that of reference standard D. HPLC-ESI-MS The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the Chromatogram of the Standard preparation, as obtained in the Assay. |
Crystallinity | Meets the requirements |
Loss on drying | ≤2.0% |
Heavy metals | ≤10ppm |
Water | ≤1.0% |
Sulphate ash | ≤0.5%, determined on 1.0g |
Related substances | Unspecified impurities for each impurity : ≤0.10% Total impurity : ≤0.5% |
Purity | ≥99% |
Assay | 99.0%-101.0%(anhydrous substance) |
Microbiological Analysis | |
Total plate count | ≤1000cfu/g |
Yeast and Molds | ≤100cfu/g |
E.Coli. | Absent |
Salmonella | Absent |
S.aureus | Absent |