Description

Cefazolin Impurity 20 is a specified impurity of the first-generation cephalosporin antibiotic, Cefazolin Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical laboratories, quality assurance departments, and manufacturers within the global pharmaceutical industry to ensure the purity, safety, and efficacy of Cefazolin Sodium API and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 20 in Cefazolin Sodium Active Pharmaceutical Ingredient (API) and finished formulations.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Critical for routine batch analysis to monitor impurity profiles and ensure product specifications meet pharmacopeial standards (USP, EP, JP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Cefazolin, supporting the development of more stable formulations.

Basic Information

Product Name	Cefazolin Impurity 20
CAS No.	1675244-99-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Related Compound 20; Cefazolin EP Impurity J; Cefazolin USP Impurity; (6R,7R)-3-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefazolin Degradant; Cefazolin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 20 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP/GLP environments and regulatory filings.

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 material should be kept in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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