| Product Name | Paracetamol | |
| Shel Life | 3 years | |
| Tests | Specification | Results |
| Appearance | White or almost free flowing granules | White free flowing granules |
| Identification |
A:The IR spectra of the sample compares to that of the standard |
Positive |
| B:The retention times of the major peaks from the sample solution correspond to those from the standard solution, as obtained in the Assay | Positive | |
| Water | 0.6%-1.5% | 0.72% |
| Bulk density | 0.40-0.60 g/ml | 0.48g/ml |
| Tapped density | 0.50-0.69g/ml | 0.59g/ml |
| Organic impurities | Related compound B N- (4-HydroxyphenyI) propanamide not more than 0.05% | 0.02% |
| Related compound C N- (2-HydroxyphenyI) acetamide not more than 0.05% | 0.004% | |
| Related compound D (N-Phenylacetamide) not more than 0.05% | 0.0003% | |
| Related compound J N-(4-ChlorophenyI) acetamide (p-chloroacetanilide) not more than 0.001% | Not detected | |
| Individual unspecified impurity not more than 0.05% | 0.007% | |
| Total impurities not more than 0.1% | 0.04% | |
| Free p-aminophenol | Not more than 0.005% | 0.0003% |
| Particle size(sieve) | Retained on US No.60: NMT 25.0% | 22.8% |
| Retained on US No.100: NMT 70.0% | 57.5% | |
| Retained on US No.200: NMT 95.0% | 84.3% | |
| Retained on US No.325: NLT 80.0% | 95.6% | |
| Residue on ignition | Not more than 0.14% | 0.07% |
| Heavy metals | Not more than 0.001% | Less than 0.001% |
| Assay(anhydrous basis) | 87.5%～92.5% | 90.0% |
| Microbial limits | Total aerobic microbial count not more than 1000cfu/g | Less than 10cfu/g |
| Total combined molds and yeasts count not more than 100cfu/g | Less than 10cfu/g | |
| Escherichia coli should be absent | Not detected | |
|
Salmonella should be abent |
Not detected | |
| Residual solvents | Not applicable as no solvents are used in the manufacturing process of PARACETAMOL ( ACETAMINOPHEN) DC 90% | |
| CONCLUSION: The product conforms to the above specifications | ||