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