Description

Avanafil Impurity 26 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Avanafil, a medication used to treat erectile dysfunction. It serves as a key marker for identification and quantification during the rigorous quality control processes in pharmaceutical development and manufacturing. Pharmaceutical companies, contract research organizations (CROs), and analytical laboratories require this high-purity impurity standard to meet stringent regulatory compliance for drug substance characterization.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during Avanafil API synthesis and purification.
• Analytical Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to ensure accurate detection limits and specificity.
• Quality Control and Batch Release Testing: Employed as a system suitability standard in QC laboratories to confirm the performance of chromatographic systems for Avanafil drug substance and product testing.
• Stability Studies and Forced Degradation: Acts as a benchmark to study the degradation pathways of Avanafil and to establish appropriate storage conditions and shelf-life.
• Regulatory Submissions and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity levels to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Research and Development: Utilized in pharmacokinetic and metabolic studies to understand the fate of this impurity in biological systems.

Basic Information

Product Name	Avanafil Impurity 26
CAS No.	2250242-42-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound 26; Avanafil Specified Impurity 26; Avanafil EP Impurity 26; Avanafil USP Impurity 26; 4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide Impurity; STENDRA Impurity 26; SPEDRA Impurity 26
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity 26 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the exacting requirements of pharmaceutical reference standard users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, identity confirmation (IR, MS), and residual solvent analysis. We support compliance with ICH, USP, and EP guidelines.

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 after opening to prevent degradation. Keep the container tightly sealed when not in use.

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%
Residual Solvents (GC)	Complies with ICH Q3C
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.