Description

E-Cefotaxime, also known as Cefotaxime Impurity D (Ep), is a critical pharmaceutical reference standard and impurity used in the quality control of the third-generation cephalosporin antibiotic, Cefotaxime. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a key marker in analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, development, and quality assurance of antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Cefotaxime Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling of Cefotaxime sodium.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopoeial standards (e.g., USP, EP, JP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Serves as a critical tool in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes for Cefotaxime.

Basic Information

Product Name	E-Cefotaxime, Cefotaxime Impurity D (Ep)
CAS No.	65715-12-0
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.47 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; (6R,7R)-7-[2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefotaxime E-Isomer; Cefotaxime Impurity E; Cefotaxime Related Compound D; Epimer of Cefotaxime
EINECS	Contact for details

Quality Control

Our E-Cefotaxime (Cefotaxime Impurity D) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with the requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, related substances, and identification tests performed via HPLC, IR, and other pharmacopoeial methods. Our quality commitment supports compliance with cGMP and relevant ICH 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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities: ≤ 5.0% Any individual impurity: ≤ 2.0%
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.