Description

Cefotetan Impurity 3 is a specified impurity and degradation product of the second-generation cephalosporin antibiotic, Cefotetan. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Cefotetan API and its finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefotetan Impurity 3 in active pharmaceutical ingredients (API) and finished drug formulations.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this specific impurity during stability testing and forced degradation studies of Cefotetan, helping to establish shelf-life and storage conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity profiles and demonstrating comprehensive quality control measures for Cefotetan-based products.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways and mechanisms of Cefotetan under various environmental conditions.
• Quality Assurance & Batch Release Testing: Integral to in-process control and final batch release testing to ensure impurity levels are within specified pharmacopeial limits (e.g., USP, EP).

Basic Information

Product Name	Cefotetan Impurity 3
CAS No.	67366-04-5
Molecular Formula	C17H17N7O8S4
Molecular Weight	575.62 g/mol
Synonyms	(6R,7R)-7-[[(4-Ethyl-2,3-dioxo-1-piperazinyl)carbonyl]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; 7-Methoxy Cefotetan; Cefotetan 7α-Methoxy Impurity; Cefotetan Related Compound C; 1-[[(6R,7R)-7-Amino-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]thio]-1-methyl-1H-tetrazole-5-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Cefotetan Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.