Description

Cefotaxime Impurity C 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 regulatory compliance. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the purity, safety, and efficacy of Cefotaxime-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefotaxime Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to monitor impurity levels against ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing.
• Regulatory Submissions: Required for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the US FDA, EMA, and others.
• Research on Degradation Pathways: Used in research settings to study the chemical behavior and degradation mechanisms of Cefotaxime.

Basic Information

Product Name	Cefotaxime Impurity C
CAS No.	68744-45-6
Molecular Formula	C16H16N5O7S2
Molecular Weight	454.46 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-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)ceph-3-em-4-carboxylic Acid; Cefotaxime Acid; Deacetylcefotaxime; Cefotaxime Related Compound C
EINECS	Contact for details

Quality Control

Our Cefotaxime Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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