Description

Avanafil Impurity 17 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Avanafil, a medication used to treat erectile dysfunction. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in drug development and regulatory compliance. The use of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Avanafil Impurity 17 in Avanafil API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor and control impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure API and drug products comply with specified impurity limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to determine product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a critical tool in synthetic chemistry research for process optimization and impurity profiling during Avanafil synthesis.

Basic Information

Product Name	Avanafil Impurity 17
CAS No.	2250242-12-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound 17; Avanafil Impurity; Avanafil Process Impurity; STENDRA Impurity; 4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide Impurity; Avanafil Specified Impurity; PDE5 Inhibitor Impurity; Research Compound 2250242-12-5
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity 17 is manufactured and handled under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing purity, assay, and impurity profile. We support compliance with ICH guidelines (Q3A, Q6A) and can provide materials suitable for use in GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay	≥ 97.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 3.0%

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