Description

Cefixime impurity 13/Cefixime TBE impurity A/Cefixime tert-Butyl Ester/(6R,7R)-7-((Z)-2-(2-aminothiazol-4-yl)-2-((2-(tert-butoxy)-2-oxoethoxy)imino)acetamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity and a key synthetic intermediate in the production and analysis of the third-generation cephalosporin antibiotic, Cefixime. It is essential for analytical chemists, quality assurance laboratories, and R&D departments within the global pharmaceutical industry to ensure drug purity, safety, and regulatory compliance. The accurate identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefixime TBE impurity A in drug substance and finished product analysis.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Impurity Profiling & Characterization: Used in stability studies and forced degradation studies to monitor impurity levels and understand degradation pathways of Cefixime API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Synthetic Intermediate: Serves as a protected ester intermediate in the chemical synthesis and process development of Cefixime.
• Quality Assurance/Quality Control (QA/QC): Enables in-house testing and batch release by providing a benchmark for impurity limits as per USP, EP, or other pharmacopeias.

Basic Information

Item	Details
Product Name	Cefixime impurity 13 / Cefixime TBE impurity A / Cefixime tert-Butyl Ester
CAS No.	79368-92-6
Molecular Formula	C22H25N5O7S2
Molecular Weight	535.60 g/mol
Synonyms	Cefixime tert-Butyl Ester; Cefixime Impurity 13; Cefixime TBE Impurity A; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-[(2-tert-butoxy-2-oxoethoxy)imino]acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefixime Related Compound A (TBE); tert-Butyl (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-[(carboxymethoxy)imino]acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate (protected form); Cefixime Ester Impurity.
EINECS	Contact for details

Quality Control

Every batch of Cefixime impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters. We support regulatory requirements for pharmaceutical impurities and can supply materials suitable for use as in-house or official reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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