Description

Cefazolin Impurity B 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 quality control and analytical method validation. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefazolin drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity B in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3B(R2)).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification in regulatory filings (e.g., ANDA, NDA, CMC documentation) to health authorities like the FDA and EMA.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Cefazolin to improve formulation stability and shelf-life.

Basic Information

Product Name	Cefazolin Impurity B
CAS No.	1798390-47-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(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 Related Compound B; Cefazolin EP Impurity B; Cefazolin USP Impurity B; Cefazolin Degradation Product; 1H-Tetrazole-1-acetic acid, 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid derivative
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.