Description

Cefotaxime Impurity F is a specified impurity and degradation product of the third-generation cephalosporin antibiotic, Cefotaxime Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Cefotaxime API and its finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefotaxime Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3B(R2)).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to determine drug shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Cefotaxime.

Basic Information

Product Name	Cefotaxime Impurity F
CAS No.	175032-97-0
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.47 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 7β-[2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-(hydroxymethyl)-3-cephem-4-carboxylic Acid; Cefotaxime Impurity F (EP); Cefotaxime Related Compound F; Desacetylcefotaxime Lactone; Cefotaxime δ-3 Isomer
EINECS	Contact for details

Quality Control

Every batch of Cefotaxime Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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