Description

Cefazedone Impurity 14 is a designated chemical reference standard used in the analytical profiling and quality control of the antibiotic Cefazedone. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance sectors for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Cefazedone drug substance and finished products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring drug product specifications are met.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Aids in understanding the degradation pathways and chemical stability of Cefazedone during formulation development.

Basic Information

Product Name	Cefazedone Impurity 14
CAS No.	57457-59-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-furanylmethoxy)imino]acetyl]amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-, (6R,7R)-; Cefazedone Related Compound; Cefazedone EP Impurity; Cefazedone USP Impurity; Cefazedone Degradation Product; Cefazedone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefazedone Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided and confirms compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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