ITEMS

SPECIFICATIONS

RESULTS

Appearance

White or almost white crystalline powder

Almost white crystalline powder

Identification

The IR spectrum conforms to that of reference standard.

Complies

The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay

Complies

Optical Rotation

+165.0° ~ +178.0°

+174.3°

Crystallinity

Should meet the requirements

Complies

pH

4.0 ~ 6.0

5.0

Water determination

4.2% ~6.0%

5.0%

Methanol

NMT 3000ppm

198ppm

Acetone

NMT 5000ppm

106ppm

Impurities

7-ADCA NMT 0.5%

0.06%

P-hydroxyphenylglycine NMT 0.5%

0.06%

Delta-3 cefadroxil NMT 0.15%

0.02%

Any individual unspecified impurity NMT 0.10%

0.07%

Total impurities NMT 2.0%

0.41%

Assay

Has a potency equivalent to NLT 950ug/mg and NMT 1050ug/mg of cefadroxil (C₁₆H₁₇N₃O₃S),calculated on the anhydrous basis.

1002ug/mg

Bulk Density

For information only

0.64g/ml

Tapped Density

For information only

0.75g/ml

Remarks

N,N-Dimethylaniline in this process is not utilized

Conclusion

The product complies with specification USP44