Description

Avanafil Impurity 51 is a designated impurity of the active pharmaceutical ingredient Avanafil, a medication used to treat erectile dysfunction. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of the final drug product. This high-purity standard is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of Avanafil.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Avanafil API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect process-related impurities.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Avanafil.

Basic Information

Product Name	Avanafil Impurity 51
CAS No.	1624833-89-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound 51; Avanafil Impurity; Avanafil EP Impurity 51; Avanafil USP Impurity; 4-[(3-Chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide Impurity; STENDRA Impurity; (S)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-4-((3-chloro-4-methoxybenzyl)amino)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide Impurity
EINECS	Contact for details

Quality Control

Our Avanafil Impurity 51 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) that detail the results against stringent internal specifications. Our quality commitment ensures the material is suitable for its intended use as a high-grade reference standard in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term stability, storage under inert atmosphere is recommended.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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