Description

Cefixime Impurity 9 is a specified impurity and degradation product of the third-generation cephalosporin antibiotic, Cefixime. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Cefixime API and finished drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefixime Impurity 9 in active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing impurity profiles and specifications required by pharmacopoeias (USP, EP, BP).
• Research & Development: Employed in synthetic route optimization and impurity profiling studies during the development of Cefixime and related cephalosporins.
• Quality Assurance/Quality Control (QA/QC): Routine testing of Cefixime batches to ensure impurity levels are within specified safety limits.

Basic Information

Product Name	Cefixime Impurity 9
CAS No.	108615-31-2
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 δ-3 Isomer; Cefixime Related Compound; Cefixime Impurity D (δ-3 Isomer); (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-[(carboxymethoxy)imino]acetamido]-3-vinyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; δ-3-Cefixime
EINECS	Contact for details

Quality Control

Our Cefixime Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) detailing all test results, ensuring compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards. The material is suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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