Description

Cefamandole Impurity A CAS NO 1947364-12-6 is a high-purity chemical reference standard specifically identified as a process-related impurity of the antibiotic Cefamandole. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in the development, manufacturing, and regulatory compliance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Cefamandole and related drug substances.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring final drug product meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as a marker to assess the degradation pathways and shelf-life stability of Cefamandole formulations under various storage conditions.
• Research on Degradation Pathways: Facilitates studies to understand the formation mechanism of this impurity during synthesis or storage.

Basic Information

Product Name	Cefamandole Impurity A
CAS No.	1947364-12-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefamandole Related Compound A; Cefamandole Impurity; Cefamandole EP Impurity A; Cefamandole USP Impurity A; (6R,7R)-7-[[(2R)-2-Mandelamido]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (putative); Mandelamido Cephalosporin Impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid derivative
EINECS	Contact for details

Quality Control

Our Cefamandole Impurity A is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques. We support compliance with major pharmacopeial guidelines, and specifications can be aligned with USP/EP reference standards upon request.

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 must be kept under inert atmosphere or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to air.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single 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.