Description

Avanafil Impurity 37 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) avanafil through rigorous analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable supply of this well-characterized impurity standard is essential for maintaining compliance with stringent global pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of avanafil drug substance and finished products.
• Impurity Profiling and Identification: Essential for identifying, characterizing, and quantifying this specific impurity during stability studies and batch release testing of avanafil.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to monitor impurity levels against established specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to define impurity limits and justify the control strategy.
• Stability Indicating Method: Used to demonstrate the specificity of stability-indicating methods for avanafil formulations.

Basic Information

Product Name	Avanafil Impurity 37
CAS No.	2250242-49-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound 37; Avanafil Impurity B; Avanafil EP Impurity B; Avanafil USP Impurity; STENDRA Impurity 37; (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)-1-pyrrolidinyl)-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide Impurity; Avanafil Process Impurity; PDE5 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity 37 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a cool, dry, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
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.