Category
Cefepime
CAS Number
Cefepime STD - 123171-59-5: IMP - A - 97164-57-3 : IMP - B - 2923899-40-3 : IMP - F - NA ;
Alternate CAS Number
123171-59-5(DiHCl monohydrate);107648-80-6(HCl Salt)
Molecular Formula
Cefepime STD - C19H28Cl2N6O6S2 : IMP - A - C19H24N6O5S2 : IMP - B - C25H29N9O7S3 : IMP - F - C32H42N9O7S3
Molecular Weight
Cefepime STD - 571.50 g/mol : IMP - A - 480.6 g/mol : IMP - B - 663.76 g/mol : IMP - F - 760.93 g/mol ;
Synonym

Cefepime - 1-[[(6R,7R)-7-[[(2Z)-(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium Inner Salt Dihydrochloride Monohydrate;

Cefepime EP Impurity A -(6R,7R)-7-[[(2E)-(2-Aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate ;

Cefepime EP Impurity B -(6R,7R)-7-[[(2Z)-[2-[[(2Z)-(2-Aminothiazol-4-yl)-(methoxyimino)acetyl] amino] thiazol-4-yl](methoxyimino)-acetyl]amino]-3-[(1-methylpyrrolidinio) methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate ;

Cefepime EP Impurity F -(6R,7R)-7-((6R,7R)-7-((Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((1-methylpyrrolidin-1-ium-1-yl)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxamido)-3-((1-methylpyrrolidin-1-ium-1-yl)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate ;

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Cefepime Dihydrochloride Monohydrate can be used in system suitability testing (SST) for HPLC as a certified reference standard (CRS) to ensure the chromatographic system is working properly. It helps verify parameters like retention time, peak shape, resolution, and repeatability, ensuring accurate and reproducible analysis of Cefepime in pharmaceutical formulations.