Tests | Specification | Results |
Characters | Appearance | A white or almost white, crystalline powder | Conforms |
Solubility | Sparingly soluble in water, freely soluble in alcohol | Conforms |
Identification | Mp | 168ºC~172ºC | 169.6ºC~169.9ºC |
IR | Consistent with the spectrum of paracetamol CRS | Conforms |
Loss on drying | ≤0.5% | 0.06% |
Sulphated ash | ≤0.1% | 0.04% |
Heavy Metals | ≤20ppm | < 20ppm |
Related substances | Impurity J | ≤10 ppm | Below LOD |
Impurity K | ≤50ppm | Below LOD |
Impurity F | ≤0.05% | Below LOD |
Any other impurity | ≤0.05% | < 0.05% |
Total of other impurities | ≤ |
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