| Grade Standard: | Medicine Grade |
|---|---|
| Type: | Chemical Reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| Standard: | Cp,USP,Bp,Ep |
| Transport Package: | Drum |
| Samples: |
|---|
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Audited Supplier | TEST | SPECIFICATIONS | RESULT |
| DESCRIPTION | Yellow crystalline powder , odourless , and unstable when met light | Yellow crystalline powder , odourless , and unstable when met light |
| IDENTIFICATION | ||
| A. IR SPECTRUM | INFRARED ABSORPTION < 197K > : The IR absorption spectrum should be concordent with the spectrum obtained with Nifedipine working reference standard. |
Concordent with the reference spectrogram |
| B. TLC | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. | Complies |
| ORGANIC IMPUIRTIES( By HPLC ) | Nifedipine nitrophenylpyridine analog a : NMT 0.2 % ; Nifedipine nitrosophenylpyridine analog b : NMT0.2 % |
Impurity a : 0.01 % Impurity b : ND |
| LIMIT OF CHLORIDE AND SULFATE | ||
| Chloride | NMT 0.02 % | Less than 0.02 % |
| Sulfate | NMT 0.05 % | Less than 0.05 % |
| PERCHLORICE ACID TITRATION | ||
| Perchloric acid | NMT 0.12 mL | Less than 0.12 mL |
| SPECIFIC TESTS | ||
| Loss on d ing < 731> | ≤ 0.5 % | 0.1 % |
| Residue on ignition < 281 > | ≤ 0.1 % | 0.05 % |
| Heavy metals | Not more than 10 PPM | Less than 10 PPM |
| Microbial Limits | Total aerobic bacteria count : ≤ 1000 cfu / g Total combined moulds / yeasts count : ≤ 100 cfu/g Escherichia coli : Absence |
Total aerobic bacteria count :15 cfu/g Total combined moulds / yeasts count : < 10cfu/g Escherichia coli : ND |
| ASSAY | Nifedipine contains NLT 98.0 % and NMT 102.0 % of nifedipine ( C17H18N2O6 ), calculated on the dried basis |
99.6 % |
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