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Cefazolin 3-hydroxy methyl Impurity

  • CAT Number DCTI-C-1470
  • CAS Number NA
  • Molecular Formula C11H12N6O5S (Free Base) C27H47N7O5S (Tetra butyl ammonium Salt)
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Cefprozil Amide

  • CAT Number DCTI-C-1338
  • CAS Number NA
  • Molecular Formula C26H26N4O7S
  • Molecular Weight 538.57
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Cefprozil delta-3 Isomer

  • CAT Number DCTI-C-1340
  • CAS Number 1000980-59-5
  • Molecular Formula C18H19N3O5S
  • Molecular Weight 389.43
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Cefprozil Dimer

  • CAT Number DCTI-C-1339
  • CAS Number NA
  • Molecular Formula C36H36N6O9S2
  • Molecular Weight 760.83
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Cefprozil EP Impurity H

  • CAT Number DCTI-C-1342
  • CAS Number NA
  • Molecular Formula C26H26N4O7S
  • Molecular Weight 538.58

Cefprozil Related compound D

  • CAS NUMBER 106447-44-3 (Free base)
  • MOLECULAR FORMULA C10H12N2O3S (Free base); C10H13ClN2O3S (HCl Salt)
  • MOLECULAR WEIGHT 240.28 (Free Base); 276.74 (HCl Salt)

General Information

Cefprozil Impurities and Cefprozil 

Daicel Pharma synthesizes Cefprozil impurities of exceptional quality, such as Cefazolin 3-hydroxy methyl Impurity, Cefprozil Amide, Cefprozil delta-3 Isomer, Cefprozil Dimer and Cefprozil EP Impurity H. These impurities are crucial to assess the purity, reliability, and safety of Cefprozil, an active pharmaceutical ingredient. Besides, Daicel Pharma provides custom synthesis of Cefprozil impurities to meet clients’ demands for delivery worldwide.

Cefprozil [CAS: 92665-29-7] is a beta-lactam antibiotic of the semi-synthetic cephalosporin class that exhibits bactericidal activity. It treats bronchitis and bacterial infections affecting the skin, ear, and respiratory systems.

Cefprozil: Use and Commercial Availability 

Cefprozil is a second-generation cephalosporin antibiotic with a structure similar to cefadroxil, a first-generation cephalosporin. Cefprozil exhibits activity against various bacteria such as S. pyogenes, S. pneumoniae, Neisseria spp., H. influenzae, M. catarrhalis, E. coli, P. mirabilis, Klebsiella, and staphylococci to a lesser extent. Its approved uses include treating acute otitis media, mild lower respiratory tract infections, acute sinusitis, and skin and skin structure infections. Cefprozil treats suppurative skeletal infections in children. It is available under the tradename Cefzil.

Cefprozil Structure and Mechanism of Action Cefprozil Structure and Mechanism of Action

The chemical name of Cefprozil is (6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-(1-propen-1-yl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Its chemical formula is C18H19N3O5S, and its molecular weight is approximately 389.4 g/mol.

Cefprozil inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) present in the cytoplasmic membrane of bacteria.

Cefprozil Impurities and Synthesis

Impurities can form in the synthesis1 and storage of Cefprozil, including degradation products2 and residual solvents. They affect the quality, safety, and efficacy of the drug product. So, it is necessary to control and monitor the levels of impurities in Cefprozil through appropriate analytical methods during its manufacture and storage. The regulatory authorities have established limits for these impurities to ensure the quality of the drug product.

Daicel Pharma offers a Certificate of Analysis (CoA) for Cefprozil impurity standards, such as Cefazolin 3-hydroxy methyl Impurity, Cefprozil Amide, Cefprozil delta-3 Isomer, Cefprozil Dimer and Cefprozil EP Impurity H, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity. Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Cefprozil impurities or degradation products. A complete characterization report accompanies every delivery.



Frequently Asked Questions

Regulatory authorities require pharmaceutical companies to identify and control impurities in Cefprozil according to specific guidelines and demonstrate compliance with these requirements.

Yes, impurities in Cefprozil can affect its bioavailability and may result in decreased absorption or altered pharmacokinetics.

Cefprozil is stored under specific conditions, including temperature and humidity control, to prevent the formation of impurities.

Cefprozil impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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