Description

Cefazolin Impurity 6 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 in the analytical profiling and quality control of Cefazolin drug substances and finished products. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure product purity, safety, and regulatory compliance. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards set by bodies such as the USP and EP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefazolin Impurity 6 in Cefazolin Sodium API and finished drug products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Cefazolin.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Cefazolin, complying with ICH guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research and Development: Supports impurity profiling and route scouting during the synthesis and process optimization of Cefazolin.

Basic Information

Product Name	Cefazolin Impurity 6
CAS No.	66636-33-7
Molecular Formula	C14H14N8O4S3
Molecular Weight	454.51 g/mol
Synonyms	(6R,7R)-3-[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-yl)acetyl]amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 7-Tetrazolylacetamido-3-[(5-methyl-1,3,4-thiadiazol-2-yl)thiomethyl]-3-cephem-4-carboxylic Acid; Cefazolin Related Compound F (EP); Cefazolin Impurity F; Cefazolin EP Impurity F; Cefazolin USP Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere or in a desiccator to maintain stability.

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% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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