Perindopril erbumine CAS NO.107133-36-8

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