Description

Cefotaxime Impurity CAS NO 23628-59-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Cefotaxime Sodium. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development, impurity profiling, and stability studies to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Cefotaxime Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for antibiotic analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Compliance and Submissions: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Research and Development: Utilized in synthetic chemistry and pharmacokinetic research to study the degradation pathways and metabolism of cephalosporin antibiotics.

Basic Information

Product Name	Cefotaxime Impurity
CAS No.	23628-59-3
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.47 g/mol
Synonyms	(6R,7R)-3-[(Acetyloxy)methyl]-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 3-Acetoxymethyl-7-[2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido]ceph-3-em-4-carboxylic acid; Cefotaxime Related Compound; Cefotaxime Impurity A; Deacetylcefotaxime; Desacetyl Cefotaxime; Cefotaxime Acid
EINECS	Contact for details

Quality Control

Our Cefotaxime Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets high-purity reference standard requirements. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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