Description

Avanafil Impurity CAS NO 2221018-00-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of impurities in Avanafil active pharmaceutical ingredient (API) and finished drug products. It is an essential tool for research scientists, analytical chemists, and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify specific impurities during the development and manufacturing of Avanafil.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to ensure Avanafil API and drug products meet stringent purity specifications per ICH Q3A/B guidelines.
• Stability Studies: Used to monitor the formation of degradation products in Avanafil formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Contract Research and Testing Laboratories: A vital reagent for CROs and analytical service providers offering impurity testing and identification services.

Basic Information

Product Name	Avanafil Impurity
CAS No.	2221018-00-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound; Avanafil Impurity Standard; Avanafil Specified Impurity; Avanafil Process Impurity; Avanafil Degradant; STENDRA Impurity; 2221018-00-2; (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity CAS NO 2221018-00-2 is manufactured and handled under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity content. We support compliance with ICH guidelines and cGMP standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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