Cefradine

Items 

Specifications

Results

Appearance

White to off-white, crystalline powder.

Off-white powder

Solubility

Sparingly soluble in water, very slightly soluble in alcohol and in chloroform, practically insoluble in ether.

Complies

Identification 

The IR spectrum confirm to that of reference standard.

Complies

Crystallinity

Meet the requirements

Complies

pH

3.5 to 6.0

5.0

Water

Not more than 6.0%

3.6%

Limit of Cephalexin

Not more than 5.0%

1.3%

Related substance

7-ADCA

NMT 1.0% 

Not found

Any other impurity

NMT 2.0%

1.3%

Total

NMT 2.5%

1.4%

N,N-Dimethylformamide

NMT 0.088%

Not found

Acetone

NMT 0.3%

0.004%

Dichloromethane

NMT 0.06%

0.003%

Assay

90.0% to 105.0%

99.2%