Tests

Standards

Results

Appearance

White or almost white ,crystalline powder.

White,crystalline powder.

Identification

A:IR absorption

Complies

Complies

B:UV absorption

Complies

Complies

C:TLC

Complies

Complies

Melting point

168~172C

169.0~170.9C

Water

Not more than0.5%

0.08%

Related substance

Impurity(chloroacetanilide)not more than 10 ppm

2ppm

Impurity K(4-aminophenol)not more than 50 ppm

15 ppm

Impurity F(4-nitrophenol)not more than 0.05%

Not detected

any other impurity not more than 0.05%

0.01%

Total of other impurities not more than 0.1%

0.02%

Residue on ignition

Not more than 0.1%

0.05%

Chloride

Not more than 0.014%

Less than 0.014%

Sulfate

Not more than 0.02%

Less than 0.02%

Sulfide

Conforms

Conforms

Heavy metals

Not more than 0.001%

Less than 0.001%

Free p-aminophenol

Not more than 0.005%

Less than 0.005%

Limit of P-chloroacetanilide

Not more than 0.001%

Less than 0.001%

Readily carbonizable substances

Conforms

Conforms

Residual solvents

Residual content of acetic acid is limited by the test of loss on dryingnot more than0.5%

0.08%

Assay(anhydrous basis)

99.0~101.0%

99.60%

Conclusion: Complies with USP34/ BP2011