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Nifedipine

CAS No:21829-25-4
Shelf life:3 years
The detailed specifications are as below:

ItemsStandard
DESCRIPTIONYellow crystalline powder , odourless , and unstable when met light
IDENTIFICATION
A. IR SPECTRUMINFRARED ABSORPTION < 197K > :
The IR absorption spectrum should be concordent with the spectrum obtained with Nifedipine working reference standard.
B. TLCThe retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ORGANIC IMPUIRTIES( By HPLC )Nifedipine nitrophenylpyridine analog a :
NMT 0.2 % ;
Nifedipine nitrosophenylpyridine analog b : NMT0.2 %
LIMIT OF CHLORIDE AND SULFATE
ChlorideNMT 0.02 %
SulfateNMT 0.05 %
PERCHLORICE ACID TITRATION
Perchloric acidNMT 0.12 mL
SPECIFIC TESTS
Loss on drying < 731>≤ 0.5 %
Residue on ignition < 281 >≤ 0.1 %
Heavy metalsNot more than 10 PPM
Microbial LimitsTotal aerobic bacteria count :
 ≤ 1000 cfu / g
Total combined moulds / yeasts count :
 ≤ 100 cfu/g
Escherichia coli : Absence
ASSAYNifedipine contains NLT 98.0 % and NMT 102.0 % ofnifedipine ( C17H18N2O6 ), calculated on the dried basis