ITEMS

STANDARD

RESULTS

Appearance

White to off-white, crystalline powder. Sparingly soluble in water, very slightly soluble in alcohol and in chloroform, practically insoluble in ether.

Off-white powder

Solubility

Complies

Identification

The IR spectrum confirm to that of reference standard

Complies

Crystallinity

Meet the requirements

Complies

PH

3.5 to 6.0

4.8

Specific optical rotation

+80.0° to +90.0°

+86°

Water

Not more than 4.3%

0.043

Limit of Cephalexin

Not more than 5.0%

0.013

Related substance

 7-ADCA

NMT 1.0%

0.00002

 Any other impurity

NMT 2.0%

0.014

 Total

NMT 2.5%

0.015

N,N-Dimethylaniline

Not more than 20 ppm

Not found

Acetone

NMT 0.3%

0.000002

Dichloromethane

NMT 0.06%

Not found

Sulphated ash

NMT 0.2%

0.0008

Assay

99.0% to 105.0%