Acetaminophen (Paracetamol) granule DC96 for tablets

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