Description

Cefditoren Pivoxil-D3 is a deuterium-labeled analog of the third-generation cephalosporin antibiotic, Cefditoren Pivoxil. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development and quality control of cefditoren pivoxil formulations.

Application

• Internal Standard for LC-MS/MS: Primary application as a deuterated internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of cefditoren pivoxil and its metabolites in biological matrices.
• Pharmacokinetic Studies: Enables accurate measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of the parent drug.
• Bioequivalence Testing: Critical for ensuring analytical method validity in studies comparing generic and innovator drug formulations.
• Regulatory Submission Support: Provides the data integrity required for compliant submissions to agencies like the FDA and EMA.
• Quality Control & Method Development: Serves as a reference standard in the development and validation of robust analytical methods for API and finished product testing.

Basic Information

Product Name	Cefditoren Pivoxil-D3
CAS No.	2747915-67-7
Molecular Formula	C₂₅H₂₅D₃N₆O₇S₃
Molecular Weight	Approx. 621.71 g/mol
Synonyms	(6R,7R)-7-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetamido]-3-[(Z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Pivaloyloxymethyl Ester-d3; Cefditoren-d3 Pivoxil; Cefditoren Pivoxil (D3); Cefditoren Pivoxil Deuterated; Meiact-d3 (labeled analog); Spectracef-d3 (labeled analog); Stable Isotope-Labeled Cefditoren Pivoxil
EINECS	Contact for details

Quality Control

Our Cefditoren Pivoxil-D3 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay, isotopic enrichment, and impurity profile. We adhere to relevant GMP guidelines for the production of reference standards, ensuring traceability and consistency for our global pharmaceutical and research clients.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use within the primary container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D3)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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