Cefixime
Test item |
Requirement of standard |
Appearance |
White to pale yellow crystalline powder |
Specific rotation |
Specific rotation should be -75°~-88° |
Identification |
The main peak of retention time of test sample solution should be consistent with the main peak retention time of the reference substance solution |
|
Infrared absorption spectrum should be consistent with the reference substance of the map |
Acidity |
pH value should be between 2.6-4.1 |
Relevant substance |
Individual impurity not more than 0.5% Total impurities not more than 3.0% |
Methyl alcohol |
Not over 0.3% |
Ethanol |
Not over 0.5% |
Propyl alcohol |
Not over 0.5% |
Ethyl acetate |
Not over 0.5% |
Tetrahydrofuran |
Not over 0.072% |
Moisture |
Should be between 9.0%-12% |
Ignition Residue |
Not over 0.2% |
Heavy metal |
Not over 0.02‰ |
Assay determination |
Calculate as anhydride, the cefixime content( C16H15N5O7S2)should not be less than 95% |
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