Clopidogrel

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Description : White to off-white powder Identification by IR : To concordant with working standard Solubility : Freely soluble in methanol …

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Description : White to off-white powder Identification by IR : To concordant with working standard Solubility : Freely soluble in methanol Specific optical rotation (At 25°C in methanol medium) : Should be between +50° and +58° Loss on drying : NMT 0.5 % w/w Heavy Metals : NMT 20 ppm Residue on ignition : NMT 0.1% w/w Related compounds ( by HPLC) ? Clopidogrel related compound A : NMT 0.2% ? Clopidogrel related compound B : NMT 0.3% ? Clopidogrel related compound C : NMT 1.0% ? Any other impurity : NMT 0.1% ? Total impurities : NMT 1.5% Assay (by HPLC) : NLT 97.0% and NMT 101.5%

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