Amlodipine Besilate
EP6.4
Description / Characters:white to off-white powder
Identification infrared spectrum corresponds
To that of EP RS
Optica lrotation:-
EP6.4
Description / Characters:white to off-white powder
Identification infrared spectrum corresponds
To that of EP RS
Optica lrotation:- 0.10° ~+ 0.10°
Water :0.50%
Residue on ignition:0.20%
Heavy metals:0.002%
Assay:97.0%~102.0 %
Residual Solvent:
Ethanol:2000ppm
Related substances:
Impurity D:NMT 0.3%
Impurity A:NMT 0.15%
Impurity E:NMT 0.15%
Impurity F:NMT 0.15%
Unspecified impirity:NMT:0.1%
Total: impurities:0.8%
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