Description

Cefazedone Related Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Cefazedone by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and manufacturers of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of specific impurities in Cefazedone API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Cefazedone batches meet pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Employed to monitor the formation of degradation products in Cefazedone under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research on Synthesis Pathways: Used in chemical research to study and optimize the synthesis and purification processes of Cefazedone.

Basic Information

Product Name	Cefazedone Related Impurity 6
CAS No.	56187-36-1
Molecular Formula	C19H17N5O5S2
Molecular Weight	475.50 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefazedone Impurity 6; Cefazedone EP Impurity C; Cefazedone Related Compound C; Cefazedone Process Impurity; 7-ACA Thiadiazole Impurity; 5-Methyl-1,3,4-thiadiazole-2-thiol derivative of 7-ACA
EINECS	Contact for details

Quality Control

Our Cefazedone Related Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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.