Description

n-Desmethyl Rosiglitazone-D4 is a stable isotope-labeled analog of a key rosiglitazone metabolite, specifically deuterated at four positions. This high-purity reference standard is critical for ensuring accuracy and reliability in quantitative bioanalytical studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and pharmacokinetics (DMPK) research.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of n-Desmethyl Rosiglitazone in biological matrices.
• Method development and validation for bioanalytical assays supporting clinical and preclinical studies of rosiglitazone and related compounds.
• Metabolite profiling and pharmacokinetic studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of rosiglitazone.
• Quality control and assurance in the production of pharmaceutical reference materials and certified standards.
• Use in doping control and forensic analysis where detection of specific drug metabolites is required.
• Supporting regulatory submissions to agencies like the FDA and EMA by providing validated analytical data.

Basic Information

Product Name	n-Desmethyl Rosiglitazone-D4
CAS No.	1215407-67-2
Molecular Formula	C₁₇H₁₅D₄N₃O₃S
Molecular Weight	~ 357.42 g/mol
Synonyms	5-[[4-[2-(Methyl-D3)pyridinyl]methoxy]phenyl]methyl]-2,4-thiazolidinedione-2,5,5-D3; Rosiglitazone Metabolite N-Desmethyl-D4; N-Desmethyl Rosiglitazone-d4; 5-[[4-[2-[(Methyl-d3)amino]ethoxy]phenyl]methyl]-2,4-thiazolidinedione-2,5,5-d3; Deuterated n-Desmethyl Rosiglitazone; Rosiglitazone Metabolite M-10-D4; Avandia Metabolite Deuterated Standard
EINECS	Contact for details

Quality Control

Our n-Desmethyl Rosiglitazone-D4 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and LC-MS, to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided. We adhere to relevant industry guidelines for reference standard production to support GMP-compliant research and development.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Chemical Purity (HPLC)	≥ 95.0%
Isotopic Purity (Deuterium Incorporation)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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