Description

Pirfenidone-D3 is a deuterated isotopologue of the anti-fibrotic agent pirfenidone, specifically labeled with three deuterium atoms. 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 tool for pharmaceutical researchers and contract research organizations (CROs) developing and validating LC-MS/MS assays for the parent drug.

Application

• Internal Standard for Bioanalysis: Primary use as a certified internal standard in the quantitative determination of pirfenidone in biological matrices (plasma, serum, urine) via LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical studies.
• Clinical Trial Support: Critical for ensuring data integrity in bioequivalence and therapeutic drug monitoring studies related to pirfenidone.
• Method Development and Validation: Used by analytical laboratories to develop, optimize, and validate robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Reference Material: Serves as a high-purity certified reference material (CRM) for quality control in analytical testing.

Basic Information

Product Name	Pirfenidone-D3
CAS No.	1093951-85-9
Molecular Formula	C₁₂H₈D₃NO
Molecular Weight	189.23 g/mol
Synonyms	5-Methyl-1-phenyl-2-(1H)-pyridone-d3; 5-Methyl-1-phenylpyridin-2(1H)-one-d3; Pirfenidone (methyl-d3); [2H3]-Pirfenidone; Deutrated Pirfenidone; Esbriet-d3 (labeled analog); Pirespa-d3 (labeled analog); 1-Phenyl-5-methyl-2(1H)-pyridone-d3
EINECS	Contact for details

Quality Control

Every batch of Pirfenidone-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data including HPLC purity, isotopic enrichment (D-content), and spectroscopic confirmation (NMR, MS) to ensure it meets the exacting standards required for quantitative bioanalysis. A detailed Certificate of Analysis (COA) with batch-specific results is supplied with each shipment, supporting compliance with ICH Q2(R1) guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the original container is sealed after use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 99.0 atom % D
Chemical Purity (by NMR)	≥ 98.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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