Sertraline hydrochloride

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Description : Off-White to white crystalline powder. Solubility : Sparingly Soluble in Methanol. Slightly soluble in Dimethyl formamide Identi…

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Description : Off-White to white crystalline powder. Solubility : Sparingly Soluble in Methanol. Slightly soluble in Dimethyl formamide Identification : The IR spectrum of sample d should be concordant with the spectrum of reference standard Melting Range : Between 245 - 250°C Loss On Drying : NMT 0. 50 % w/w Sulphated Ash : NMT 0.10 % w/w Heavy Metals : NMT 20 ppm Optical Rotation : + 38 to + 42° Related substances by HPLC ? Single Impurity : NMT 0.20% ? Total Impurities : NMT 0.50% ? Individual impurity : NMT 0.10% Assay (on anhydrous basis) : NLT 98.0% and NMT 102.0% Residual solvents : Ethanol NMT 5000ppm Ethylacetate NMT 5000ppm IPA NMT 5000ppm

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