Description

Avanafil Impurity CAS NO 1638497-25-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Avanafil, a PDE5 inhibitor medication. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of specific impurities in Avanafil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Avanafil drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory guidelines for impurity limits.
• Stability Studies: Employed to track the formation and growth of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to characterize and justify the control strategy for impurities in the drug product.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for purer Avanafil API.

Basic Information

Product Name	Avanafil Impurity
CAS No.	1638497-25-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound; Avanafil Impurity Standard; Avanafil Specified Impurity; PDE5 Inhibitor Impurity; 4-[(3-Chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide Impurity; (S)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-4-((3-chloro-4-methoxybenzyl)amino)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide Impurity; STENDRA™ Impurity
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity (CAS 1638497-25-2) is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability conform to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B guidelines for pharmaceutical impurities.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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