Description

Cefixime Impurity 3 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 purity, safety, and efficacy of the third-generation cephalosporin antibiotic, Cefixime, by serving as a benchmark in chromatographic analysis. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefixime Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Cefixime under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, Common Technical Documents) by providing definitive impurity characterization data.
• Research and Development: Facilitates impurity profiling and route scouting during the synthesis and process optimization of Cefixime.

Basic Information

Product Name	Cefixime Impurity 3
CAS No.	2311847-19-3
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 C; Cefixime EP Impurity C; Cefixime USP Related Compound C; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(carboxymethoxyimino)acetamido]-3-vinyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefixime Impurity C
EINECS	Contact for details

Quality Control

Our Cefixime Impurity 3 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality system is designed to support compliance with ICH, USP, and EP guidelines for impurities.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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