Acetaminophen (Paracetamol) granule DC96 for tablets
Acetaminophen (Paracetamol) granule DC96 for tablets.
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- Molecular Formula： C8H9NO2
- CAS： 103-90-2
- HS：
Acetaminophen (Paracetamol) granule DC96
granulated DC96 for tablets
CAS:103-90-2 EINECS No.: 203-157-5 shelf life: three years
Product Name | Acetaminophen (Paracetamol) DC96 | Packing | 25kg/ fibre drum | ||
Tests | Specification | Results | |||
Appearance | White free flowing granules | white free flowing granules | |||
Identification | The IR spectra of the sample compares to that of the standard | Positive | |||
Loss on drying | 0.5%-1.5% | 0.70% | |||
Bulk density | 0.40-0.70 g/ml | 0.59g/ml | |||
Related substances | ImpurityJ(chloroacetanilide)not more than 10 ppm | Below LOD | |||
Impurity K(4-aminophenol)not more than 50 ppm | Below LOD | ||||
Impurity F(4-nitrophenol)not more than 0.05% | Not detected | ||||
Any other impurity not more than 0.05% | Below LOD | ||||
Total of other impurities not more than 0.1% | Below LOD | ||||
Particle size(sieve) | Retained on US No. 100：NLT 20.0% | 91.38% | |||
Retained on US No. 200：NLT 70.0% | 96.50% | ||||
Residue on ignition | Not more than 0.20% | 0.07% | |||
Heavy metals | Not more than 0.002% | Below LOD | |||
Assay(anhydrous basis) | 94.5%~97.5% | 96.11% | |||
Microbial limits | Total aerobic microbial count not more than 1000 cfu/g | Below LOD | |||
Total combined molds and yeasts count not more than 100 cfu/g | Below LOD | ||||
Escherichia coli should be absent | Not detected | ||||
Residual solvents | Not applicable as no sovents are used in the manufacturing process of PARACETAMOL（ACETAMINOPHEN）DC 96% | ||||
Conclusion： The product conforms to the above specifications | |||||