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99% Pharmaceuticals Chemical Weight Loss Orlistat Powder CAS 96829-58-2 Orlistat1
Pharmaceutical IntermediateAPIPharmaceutical
Beijing Mesochem Technology Co., Ltd.
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Product Description CERTIFICATE OF ANALYSIS Product name: Orlistat USP38 CAS: 96829-58-2 Batch no. :20161226 Quantity :50kgs Manuf. date: 2016/12/26 Expiry date: 2018/12/26 ANALYSIS TEST SPECIFICATIONS RESULTSDescription White or almost white crystalline powder Conforms Specific rotation -48°~-51°(on the anhydrous, solvent -free basis ) -49.3°Identification The result of HPLC is consistent to the reference one. The result of IR consistent to the reference one. Conforms Water ≤0.2% 0.05% Related substances Total impurity ≤1.0% 0.4% Individual unidentified inpurity ≤0.1% 0.02%Related compound A(by HPLC) ≤0.2% Conforms Related compound B(by GC) ≤0.05% NDRelated compound C(by HPLC) ≤0.05% ConformsFormylleucine ≤0.2% Conformsopen ring epimer ≤0.2% ConformsD-leucine ≤0.2% ConformsRelated compound D(by HPLC) ≤0.2% ConformsOpen ring amide ≤0.1% ConformsRelated compound E(by HPLC) ≤0.2% 0.09% Heavy metal ≤20ppm Conforms Assay 98.0%~101.5%(on the anhydrous,solvent -free 99.8% basis) CONCLUSION: THE PRODUCT CONFORMS WITH USP38
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