Description

Cefmetazole Sodium Impurity 20 is a designated impurity of the second-generation cephamycin antibiotic, Cefmetazole Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient. It is primarily required by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefmetazole Sodium Impurity 20 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating precise analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications to ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research on Degradation Pathways: Aids in research to elucidate the degradation mechanisms of Cefmetazole Sodium.

Basic Information

Item	Detail
Product Name	Cefmetazole Sodium Impurity 20
CAS No.	70953-18-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7S)-7-[[(Cyanomethyl)thio]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefmetazole Impurity 20; Cefmetazole Related Compound 20; Cefmetazole Sodium EP Impurity 20; Cefmetazole Sodium USP Impurity 20
EINECS	Contact for details

Quality Control

Our Cefmetazole Sodium Impurity 20 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) containing batch-specific data from validated methods are provided to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). This material is light-sensitive (store away from light).

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)	Complies with individual and total limits
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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