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
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.
- Hoshi, Hideaki; Okumura, Jun; Abe, Yoshio; Aburaki, Shimpei; Naito, Takayuki, Substituted vinyl cephalosporins, Bristol-Myers Co., United States, US4520022A, May 28, 1985
- Daabees, H. G.; Mahrous, M. S.; Abdel-Khalek, M. M.; Beltagy, Y. A.; Michail, Karim, Spectrophotometric determination of cefprozil in pharmaceutical dosage forms, in urine and in the presence of its alkaline induced degradation products, Analytical Letters, Volume: 34, Issue: 10, Pages: 1639-1655, 2001
Frequently Asked Questions
The stability of Cefprozil impurities is assessed through stability studies under different conditions to determine their degradation kinetics and to establish degradation pathways.
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).
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