Tests

Standards

Appearance

White or almost white ,crystalline powder.

Identification

A:IR absorption

Complies

B:UV absorption

Complies

C:TLC

Complies

Melting point

168~172°C

Water

Not more than0.5%

Related substance

ImpurityJ(chloroacetanilide)not more than 10 ppm

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

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

any other impurity not more than 0.05%

Total of other impurities not more than 0.1%

Residue on ignition

Not more than 0.1%

Chloride

Not more than 0.014%

Sulfate

Not more than 0.02%

Sulfide

Conforms

Heavy metals

Not more than 0.001%

Free p-aminophenol

Not more than 0.005%

Limit of P-chloroacetanilide

Not more than 0.001%

Readily carbonizable substances

Conforms

Residual solvents

Residual content of acetic acid is limited by the test of loss on

dryingnot more than0.5%

Assay(anhydrous basis)

99.0~101.0%

Conclusion:   Complies with USP34/ BP2011