Description

Cefazolin Impurity 4 (Dimeric 7-Aca) is a specified impurity and degradation product of the first-generation cephalosporin antibiotic, Cefazolin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for method development, stability studies, and ensuring the purity and safety of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 4 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Cefazolin sodium.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways and stability profile of Cefazolin.
• Quality Control & Batch Release: A critical component in the quality control testing of Cefazolin API to ensure it meets pharmacopeial specifications (e.g., USP, EP, JP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research on Degradation Mechanisms: Used in academic and industrial research to study the dimerization and other degradation mechanisms of β-lactam antibiotics.

Basic Information

Product Name	Cefazolin Impurity 4 (Dimeric 7-Aca)
CAS No.	2416213-67-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Dimer Impurity; Cefazolin Related Compound D; Dimeric 7-ACA Impurity of Cefazolin; 7-ACA Dimer (Cefazolin); Cefazolin Impurity D; Cefazolin EP Impurity D; Cefazolin USP Impurity; (6R,7R)-7-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Dimer
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.