Description

Avanafil Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of avanafil, a medication for erectile dysfunction. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in avanafil active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of avanafil to understand degradation pathways and establish shelf-life.
• Process Chemistry & Optimization: Used by API manufacturers to monitor and control impurity formation during the synthesis and purification stages of avanafil production.
• Academic & Clinical Research: Serves as a research tool in pharmacokinetic, metabolic, and toxicological studies related to avanafil.

Basic Information

Product Name	Avanafil Impurity 4
CAS No.	874482-97-0
Molecular Formula	C23H26ClN7O3
Molecular Weight	483.95 g/mol
Synonyms	4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide; Avanafil Related Compound 4; Avanafil Impurity D; Avanafil EP Impurity D; Avanafil USP Impurity D; STENDRA Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with pharmacopeial monographs (USP, EP). Comprehensive characterization is performed using advanced analytical techniques (HPLC, GC, MS, NMR). Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. 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: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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