Description

Cefotaxime Impurity 15 is a designated chemical reference standard used in the analytical profiling of the antibiotic Cefotaxime Sodium. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring product purity, safety, and regulatory compliance. It is primarily required by quality control laboratories, analytical chemists, and regulatory affairs professionals within the global pharmaceutical and biotechnology industries for method development, validation, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cefotaxime Impurity 15 in Cefotaxime Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and drug product meet stringent pharmacopeial (e.g., USP, EP, JP) specifications for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research on Degradation Pathways: Aids in research to elucidate the chemical degradation mechanisms of Cefotaxime, supporting process improvement and stabilization strategies.

Basic Information

Product Name	Cefotaxime Impurity 15
CAS No.	95480-64-1
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-Hydroxymethyl Cefotaxime; Cefotaxime 3-Hydroxymethyl Derivative; Cefotaxime Impurity F (EP); Cefotaxime Related Compound F; 7β-[2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 3-Acetate Ester
EINECS	Contact for details

Quality Control

Our Cefotaxime Impurity 15 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural verification by spectroscopic methods (IR, NMR, MS). We provide full traceability and Certificates of Analysis (COA) detailing batch-specific results, ensuring compliance with the standards required for pharmaceutical reference materials.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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	≤ 1.0%
Heavy Metals	≤ 20 ppm

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