Description White or almost white crystalline powder, Slightly Hygroscopic.
Solubility Freely soluble in water and in alcohol; Sparingly soluble in methylene chloride.
Identification A. 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 HPLC Impurity B Impurity E Impurity F Impurity H Any other unknown impurity Total 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/w
Sulphated 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