Description

Hydroxy Pioglitazone-D4 (m-Iv) is a deuterated isotopologue of a key metabolite of the thiazolidinedione-class drug Pioglitazone. This stable-labeled compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in mass spectrometry-based assays. It is an essential tool for pharmaceutical R&D and clinical laboratories focused on drug metabolism and pharmacokinetic (DMPK) studies, therapeutic drug monitoring, and bioequivalence testing.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, non-interfering internal standard for the precise quantification of Pioglitazone and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Critical for investigating the metabolic pathways, clearance rates, and bioavailability of Pioglitazone in preclinical and clinical research.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis: Enables accurate measurement of drug concentration-time profiles to establish dosing regimens and efficacy.
• Therapeutic Drug Monitoring (TDM): Supports assays designed to optimize Pioglitazone therapy in patients by monitoring plasma drug levels.
• Bioequivalence and Biosimilar Studies: Used in comparative studies to assess the performance of generic formulations against reference listed drugs.
• Forensic and Clinical Toxicology: Aids in the specific and sensitive detection of Pioglitazone in forensic analysis or overdose cases.
• Method Development and Validation: Serves as a key reagent for developing, optimizing, and validating robust analytical methods in compliance with GLP/GCP guidelines.

Basic Information

Product Name	Hydroxy Pioglitazone-D4 (m-Iv)
CAS No.	1188263-49-1
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 (hydroxy metabolite); Pioglitazone Hydroxy Metabolite D4; Pioglitazone-d4 Metabolite M-IV; KRP-297 Hydroxy Metabolite-d4; AD-4833 Hydroxy Metabolite-d4; U-72107A Metabolite-d4; (±)-5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione-d4
EINECS	Contact for details

Quality Control

Every batch of Hydroxy Pioglitazone-D4 (m-Iv) is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and MS. Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles are provided with each shipment to ensure compliance with your method validation requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥98.0 atom % D
Chemical Purity	≥95.0%
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.