Description

Pirfenidone Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Pirfenidone, an anti-fibrotic medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for meeting stringent regulatory compliance in drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pirfenidone Impurity 3 in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity profiles in Pirfenidone API.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Pirfenidone meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity profiling studies during the development of Pirfenidone and its generic versions.

Basic Information

Product Name	Pirfenidone Impurity 3
CAS No.	2251047-36-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Methyl-1-phenyl-2-(1H)-pyridone Impurity; Pirfenidone Related Compound 3; Pirfenidone EP Impurity C; Pirfenidone USP Impurity; Pirfenidone Degradation Product; Pirespa Impurity; Esbriet Impurity; 1-Phenyl-5-methyl-2(1H)-pyridinone Impurity
EINECS	Contact for details

Quality Control

Every batch of Pirfenidone Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Powder
Identification (IR)	Conforms to Reference Spectrum
Identification (HPLC)	Retention time matches CRS
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total Impurities ≤ 2.0% Any Individual Unknown Impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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