CAS No:21829-25-4
Shelf life:3 years
The detailed specifications are as below:
| Items | Standard |
| DESCRIPTION | 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. | |
| 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. |
| ORGANIC IMPUIRTIES( By HPLC ) | Nifedipine nitrophenylpyridine analog a : |
| NMT 0.2 % ; | |
| Nifedipine nitrosophenylpyridine analog b : NMT0.2 % | |
| LIMIT OF CHLORIDE AND SULFATE | |
| Chloride | NMT 0.02 % |
| Sulfate | NMT 0.05 % |
| PERCHLORICE ACID TITRATION | |
| Perchloric acid | NMT 0.12 mL |
| SPECIFIC TESTS | |
| Loss on drying < 731> | ≤ 0.5 % |
| Residue on ignition < 281 > | ≤ 0.1 % |
| Heavy metals | Not more than 10 PPM |
| Microbial Limits | Total aerobic bacteria count : |
| ≤ 1000 cfu / g | |
| Total combined moulds / yeasts count : | |
| ≤ 100 cfu/g | |
| Escherichia coli : Absence | |
| ASSAY | Nifedipine contains NLT 98.0 % and NMT 102.0 % ofnifedipine ( C17H18N2O6 ), calculated on the dried basis |