Specification | Nifedipine IP | Nifedipine BP | Nifedipine USP |
---|---|---|---|
Identification | Conforms | Conforms | Conforms |
Appearance | White powder | White powder | White powder |
Melting Point | 171-175°C | 171-175°C | 171-175°C |
Loss on Drying | ≤0.5% | ≤0.5% | ≤0.5% |
Assay | 98.5-101.0% | 98.5-101.0% | 98.5-101.0% |
Heavy Metals | ≤10 ppm | ≤10 ppm | ≤10 ppm |
Residual Solvents | Complies | Complies | Complies |
Related Substances | ≤1.0% | ≤1.0% | ≤1.0% |
Microbial Limits | Complies | Complies | Complies |
Particle Size | 90% ≤10μm | 90% ≤10μm | 90% ≤10μm |
Packaging | As per BP | As per BP | As per BP |
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