Description

Cefmetazole Impurity CAS NO 56796-19-1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the antibiotic Cefmetazole. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs who require precise identification and quantification of impurities. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements for drug substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Cefmetazole-related impurities in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity profiles and ensure Cefmetazole API complies with pharmacopeial standards (e.g., USP, EP, JP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Cefmetazole.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of process-related impurities during Cefmetazole synthesis.

Basic Information

Product Name	Cefmetazole Impurity
CAS No.	56796-19-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(7R)-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 Related Compound; Cefmetazole EP Impurity; Cefmetazole USP Impurity; Cefmetazole Degradant; Cefmetazole Process Impurity
EINECS	Contact for details

Quality Control

Our Cefmetazole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters. We support compliance with cGMP and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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