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white pr off-white crystalline powder
unknown single impurity: no more than 0.1%
total impurity:0.23%
heavy metal : NMT20ppm
Orlistat (xenical)
Appearance: crystalline powder
Identification: Conforms
Melting point:40-48¡É
Rotation:-30¨¬¢¦-40¨¬
Loss on drying:2% Max
Residue on ignition: 2% Max
Solubility: Freely soluble in chloroform insoluble in water
Heavy Metals: 40PPM Max
Assay: 95% Min
Arsenic: 5PPMMax
It conforms to EP5