Description

Keto Pioglitazone-D4 (m-Iii) CAS NO 1215370-26-5 is a deuterated analog of a key pioglitazone metabolite, specifically designed for use as a high-purity internal standard in analytical chemistry. This compound is critical for ensuring the accuracy and reliability of quantitative mass spectrometry and HPLC analyses in pharmaceutical research and development. It is an essential tool for scientists and quality control laboratories in the pharmaceutical, contract research organization (CRO), and clinical diagnostics sectors who require precise and traceable reference materials for method development and validation.

Application

• Pharmaceutical R&D Internal Standard: Primary use as a stable isotope-labeled internal standard for the accurate quantification of pioglitazone and its metabolites in biological matrices via LC-MS/MS.
• Bioanalytical Method Development: Crucial for developing and validating robust, sensitive, and specific analytical methods for pharmacokinetic and pharmacodynamic studies.
• Clinical Research & Diagnostics: Enables precise measurement of drug concentrations in patient samples for therapeutic drug monitoring and clinical trial analysis.
• Metabolite Profiling & Identification: Aids in the structural elucidation and tracking of drug metabolism pathways in vitro and in vivo.
• Quality Control & Assurance: Serves as a certified reference material to ensure batch-to-batch consistency and compliance in pharmaceutical manufacturing QC labs.
• Regulatory Submissions: Provides the traceable data required for supporting regulatory filings with agencies like the FDA and EMA.

Basic Information

Item	Detail
Product Name	Keto Pioglitazone-D4 (m-Iii)
CAS No.	1215370-26-5
Molecular Formula	C19H16D4N2O3S
Molecular Weight	Approx. 358.46 g/mol
Synonyms	5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione-d4; Pioglitazone Keto Metabolite M-III-d4; Pioglitazone Keto-D4; Keto-Pioglitazone-d4; M-III Metabolite-d4; 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione (deuterated); (RS)-5-(4-[2-(5-Ethylpyridin-2-yl)ethoxy]benzyl)thiazolidine-2,4-dione-d4
EINECS	Contact for details

Quality Control

Every batch of Keto Pioglitazone-D4 (m-Iii) is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a certified reference standard, including confirmation of isotopic purity and chemical identity. A detailed Certificate of Analysis (COA) is supplied with each product, documenting purity (typically ≥95% by HPLC), isotopic enrichment, and results from NMR and mass spectrometry characterization. Our quality protocols are designed to meet the rigorous demands of GMP/GLP-compliant laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95%
Isotopic Purity (D-enrichment)	≥ 98 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.