Description

Cefotaxime Impurity 6 is a specified impurity and degradation product of the third-generation cephalosporin antibiotic, Cefotaxime Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefotaxime-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefotaxime Impurity 6 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities in Cefotaxime Sodium.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways and stability profile of Cefotaxime.
• Quality Control & Batch Release: A critical component in the quality control process to ensure batches of Cefotaxime API meet stringent pharmacopeial specifications (e.g., USP, EP, ICH).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., ANDA, NDA, CMC) by providing impurity profiles required by agencies like the FDA and EMA.
• Research on Degradation Chemistry: Used in research to study the formation mechanisms and chemical behavior of this specific impurity.

Basic Information

Product Name	Cefotaxime Impurity 6
CAS No.	123238-79-9
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.47 g/mol
Synonyms	(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 3-Hydroxymethyl Cefotaxime; Cefotaxime Impurity F (EP); Cefotaxime Related Compound F; Cefotaxime 3-Hydroxymethyl Derivative; Desacetylcefotaxime (common misnomer, check structure); Cefotaxime Metabolite (potential); Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Our Cefotaxime Impurity 6 is manufactured and controlled under a strict quality management system. Each batch is subjected to rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) that include batch-specific data, ensuring traceability and compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

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 inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.