Description

Cefotaxime Impurity 23 (Cefotaxime Bromoacetyl Analog) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of the antibiotic Cefotaxime sodium. It is essential for analytical laboratories and pharmaceutical manufacturers focused on method development, stability studies, and ensuring drug safety and efficacy according to stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Cefotaxime sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling and identification.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels to meet ICH, USP, and EP specifications.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability testing of Cefotaxime formulations.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefotaxime.

Basic Information

Product Name	Cefotaxime Impurity 23 (Cefotaxime Bromoacetyl Analog)
CAS No.	83305-12-8
Molecular Formula	C16H17N5O7S2
Molecular Weight	455.47 g/mol
Synonyms	(6R,7R)-7-[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetamido]-3-[(bromoacetyl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 3-[(Bromoacetyl)methyl]cefotaxime; Cefotaxime Bromoacetyl Derivative; Cefotaxime Related Compound 23; Cefotaxime EP Impurity G; Cefotaxime Bromoacetyl Analog; Bromoacetyl Cefotaxime
EINECS	Contact for details

Quality Control

Every batch of Cefotaxime Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing desiccated under inert atmosphere.

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)	Single unspecified 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.