Description

Cefmetazole Sodium Impurity 25 is a characterized impurity of the second-generation cephamycin antibiotic, Cefmetazole Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of Cefmetazole Sodium to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefmetazole Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Cefmetazole Sodium meets stringent pharmacopeial specifications (e.g., USP, EP, JP) for impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Cefmetazole Sodium.

Basic Information

Product Name	Cefmetazole Sodium Impurity 25
CAS No.	73707-53-6
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 Impurity 25; Cefmetazole Related Compound 25; Cefmetazole Sodium EP Impurity 25; Cefmetazole Sodium USP Impurity 25
EINECS	Contact for details

Quality Control

Every batch of Cefmetazole Sodium Impurity 25 is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, MS, and NMR to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.