Description

Cefmetazole Impurity 9/(6R-Cis)-7-[[[(Cyanomethyl)Thio]Acetyl]Amino]-3-(Hydroxymethyl)-7-Methoxy-8-Oxo-5-Thia-1-Azabicyclo[4.2.0]Oct-2-Ene-2-Carboxylic Acid is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control of Cefmetazole, a second-generation cephamycin antibiotic. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method development, validation, and regulatory compliance. Supplied with comprehensive analytical data, this impurity standard ensures accurate identification and quantification to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefmetazole Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical component for developing and validating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure Cefmetazole meets pharmacopeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity profiling, route scouting, and process chemistry optimization during the synthesis of Cefmetazole.

Basic Information

Item	Details
Product Name	Cefmetazole Impurity 9
CAS No.	70953-19-4
Molecular Formula	C15H17N3O7S2
Molecular Weight	415.44 g/mol
Synonyms	(6R-Cis)-7-[[[(Cyanomethyl)Thio]Acetyl]Amino]-3-(Hydroxymethyl)-7-Methoxy-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 Impurity C (Potential); 7β-[[(Cyanomethylthio)acetyl]amino]-7α-methoxy-3-[(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Cefmetazole Impurity 9 is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Our quality system is designed to support pharmaceutical development and complies with current industry best practices. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from multiple orthogonal analytical techniques including HPLC, NMR, and MS. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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