We offer PERINDOPRIL Our Quality is according to latest pharmacopeia PERINDOPRILSpecification TEST &n
We offer PERINDOPRILOur Quality is according to latest pharmacopeia PERINDOPRIL Specification TEST STANDARDSDescription White or almost white crystalline powder, Slightly Hygroscopic.Solubility Freely soluble in water and in alcohol; Sparingly soluble in methylene chloride.IdentificationA. Specific Optical Rotation(On anhydrous basis)(C=1% in alcohol)B. Infrared Absorption C.Thin layer chromatography (tert-butylamine)Examine the chromatograms obtained in the test of Impurity A Between -66.0° to -69.0° The infrared absorption spectrum of substance is concordant with the IR spectrum obtained from Perindopril Tert-Butylamine working standard In the chromatogram obtains with the test solution, a spot is observed with the same Rf as the spot with higher Rf in the chromatogram with refrence solution (e) (tert-butylamine)Impurity A (By TLC) NMT 0.25%Stereochemical purity Any impurity NMT 0.1%Related Substances by HPLCImpurity BImpurity EImpurity FImpurity HAny other unknown impurityTotal Impurity Not more than 0.3%Not more than 0.4%Not more than 0.2%Not more than 0.2%Not more than 0.1%Not more than 1.0%Water content (by KF) Not more than 1.0 % w/wSulphated ash No more than 0.005%No more than 0.1%Assay by Titrimetry (%)(on anhydrous basis) NLT 99.0% and NMT 101.0% w/w
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