Description

Avanafil Impurity 46 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Avanafil. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and regulatory compliance of Avanafil-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Avanafil Impurity 46 in Avanafil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC section of NDA) by providing impurity characterization data.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Avanafil Impurity 46
CAS No.	372117-53-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[(3-Chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide; Avanafil Related Compound 46; Avanafil Impurity F; Avanafil EP Impurity F; Avanafil USP Impurity F; STENDRA Impurity 46; (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-((pyrimidin-2-yl)methyl)pyrimidine-5-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity 46 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing all test results and specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

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

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