Description

Cefazolin Impurity C CAS NO 56842-77-4 is a specified impurity and reference standard used in the analytical profiling and quality control of the antibiotic Cefazolin Sodium. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Cefazolin Sodium bulk drug and finished formulations.
• Method Development and Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurity levels in compliance with ICH guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and quantify degradation products of Cefazolin.
• Quality Control and Batch Release: A critical component in the QC testing of active pharmaceutical ingredients (APIs) to ensure batches meet stringent pharmacopeial specifications (USP, EP, JP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data for drug master files (DMFs) and marketing applications.
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and impurity formation mechanisms of cephalosporin antibiotics.

Basic Information

Item	Details
Product Name	Cefazolin Impurity C
CAS No.	56842-77-4
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-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 3-[(5-Methyl-1,3,4-thiadiazol-2-ylthio)methyl]-7-(1H-tetrazol-1-ylacetamido)-3-cephem-4-carboxylic Acid; Cefazolin EP Impurity C; Cefazolin USP Impurity C; Cefazolin Related Compound C; 1H-Tetrazole-1-acetic acid, 2-[[(6R,7R)-2-carboxy-8-oxo-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-en-7-yl]amino]-2-oxoethyl ester
EINECS	Contact for details

Quality Control

Every batch of Cefazolin Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques like HPLC and NMR 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, and residual solvents.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or 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 single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.