Description

Cefixime Impurity 4 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the third-generation cephalosporin antibiotic, Cefixime. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Cefixime API and formulations.
• Essential for method development and validation in analytical techniques such as HPLC, UPLC, and LC-MS.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits as per ICH guidelines.
• Supports quality control testing during the manufacturing process to ensure batch-to-batch consistency.
• Valuable for research and development of new synthetic routes and purification processes for Cefixime.

Basic Information

Product Name	Cefixime Impurity 4
CAS No.	297144-55-9
Molecular Formula	C16H15N5O7S2
Molecular Weight	453.45 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(carboxymethoxy)iminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefixime Related Compound; Cefixime EP Impurity D; Cefixime USP Related Compound; Cefixime δ-3 Isomer; (Z)-Isomer of Cefixime; Antibiotic Impurity
EINECS	Contact for details

Quality Control

Our Cefixime Impurity 4 is manufactured under controlled conditions to meet the stringent requirements of pharmaceutical impurity standards. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods. We provide comprehensive Certificates of Analysis (COA) that detail all test results and confirm compliance with relevant pharmacopeial standards (e.g., USP, EP). Our quality system is designed to support regulatory filings and ensure traceability.

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 in a desiccated environment to maintain stability and purity. Avoid exposure to excessive heat and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.