Description

Cefmenoxime Impurity 3 is a specified impurity of the third-generation cephalosporin antibiotic, Cefmenoxime. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and ensuring the purity and safety of Cefmenoxime API and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefmenoxime Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation impurities in Cefmenoxime under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefmenoxime.

Basic Information

Product Name	Cefmenoxime Impurity 3
CAS No.	65052-69-9
Molecular Formula	C16H17N9O5S2
Molecular Weight	479.50 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefmenoxime Related Compound C; Cefmenoxime EP Impurity C; Cefmenoxime USP Impurity C; Cefmenoxime Acid Impurity; SCEM Impurity 3
EINECS	Contact for details

Quality Control

Every batch of Cefmenoxime Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, NMR, MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to ensure long-term stability.

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 ≤ 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.