Cefixime Trihydrate

Appearnce: white to almost white or light yellow crystalline powder

Identification:

  cefixime IR: corresponding

Specific rotation (USP): -75 to -88^o ( anhydrous substance)

Sulphated ash: no more than 0.2%

Water (karl Fisher):   9.0-12.0%

Residual solvents (GC)

  Ethanol: not more than 1.0%

Related substance (HPLC): 

  Largest single impurity: no more than 0.5%

  Total impurity: no more than 3.0%

pH:  2.6-4.1

Assay:

  Cefixime, ethanol free and anhydrous: 95.0%-101.0% EP

  Cefixime anhydrous: 950 μg/mg  to 1030 μg/mg USP

Solubility:

  Methanol: freely soluble

  Ethanol: sparingly soluble

  Acetone: Sparingly soluble

  Water: slightly soluble

  ethyl acetate: practically insoluble