Description

5-Methyl-n-Phenyl-2-1H-Pyridone-D5 (Pirfenidone-D5) is a deuterated analog of the active pharmaceutical ingredient Pirfenidone, where five hydrogen atoms are replaced with deuterium. This stable isotope-labeled compound is essential for use as an internal standard in quantitative analytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical testing facilities focused on respiratory and fibrotic diseases.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of Pirfenidone in biological matrices (plasma, serum, urine) during bioanalytical method development and validation.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in mass spectrometry-based studies to track drug absorption, distribution, metabolism, and excretion (ADME) with minimal isotopic interference.
• Clinical Trial Support: Enables accurate measurement of drug concentration in patient samples during clinical trials for idiopathic pulmonary fibrosis (IPF) and other fibrotic conditions.
• Reference Material: Serves as a certified reference standard for calibrating analytical instruments and ensuring method compliance with FDA, EMA, and ICH guidelines.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of deuterated impurities or metabolites in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	5-Methyl-n-Phenyl-2-1H-Pyridone-D5 (Pirfenidone-D5)
CAS No.	1020719-62-3
Molecular Formula	C12H6D5NO
Molecular Weight	189.24 g/mol
Synonyms	Pirfenidone-d5; 5-Methyl-1-phenyl-2(1H)-pyridone-d5; 5-Methyl-1-phenylpyridin-2(1H)-one-d5; 5-Methyl-2(1H)-pyridone, 1-phenyl-, d5-; Deuteronated Pirfenidone; Isotopically Labeled Pirfenidone; [D5]-Pirfenidone; 1-Phenyl-5-methylpyridin-2(1H)-one-d5
EINECS	Contact for details

Quality Control

Every batch of Pirfenidone-D5 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and isotopic enrichment. Our products are supported by a detailed Certificate of Analysis (COA) that includes data from NMR, HPLC, and mass spectrometry. We adhere to relevant industry standards for stable isotope-labeled compounds to guarantee suitability for regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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)	≥98 atom % D
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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