Description

Avanafil Impurity CAS NO 1638497-22-9 is a high-purity chemical reference standard used in the research, development, and quality control of pharmaceutical products. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Avanafil by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable, well-characterized impurities for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Avanafil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods in R&D and QC laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., for FDA, EMA) by providing data on impurity profiles as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation of degradation products in Avanafil under various stress conditions (thermal, photolytic, hydrolytic).
• Process Chemistry & Optimization: Used to track and control the formation of this specific impurity during the synthesis and purification stages of Avanafil manufacturing.
• Quality Control Testing: A critical component in the routine batch release testing of Avanafil to ensure it meets stringent purity specifications.

Basic Information

Product Name	Avanafil Impurity
CAS No.	1638497-22-9
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; (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-((2-(hydroxymethyl)morpholino)methyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-6-carbonitrile Impurity; STENDRA Impurity
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity CAS 1638497-22-9 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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