Orlistat Orlistat Orlistat USP
We have got GMP,DMF,FDA.
Characteristics |
White to off-white crystalline powder |
Melting Point |
42℃~46℃ |
Specific optical rotation |
-48.0~ -51.0° |
Identification HPLC IR |
HPLC retention time Conforms with the reference Conforms |
Related Substance Individual impurity Total impurities |
NMT 0.2% NMT 1.0% |
Water content%(K&F) |
≤ 0.5% |
Residual solvents |
Ethanol:≤0.5% EtOAc:≤0.5% N-heptane:≤0.5% |
Residue on ignition |
≤0.2% |
Heavy metals as Pb |
≤20ppm |
Assay by HPLC(Orlistat ) |
≥99.0%(on anhydrous basis) |
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