Description

Avanafil Impurity 34 is a designated pharmaceutical reference standard used in the research, development, and quality control of avanafil, a medication for erectile dysfunction. This high-purity impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, analytical chemists, and quality assurance departments involved in the manufacturing and regulatory compliance of avanafil formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific impurity in avanafil active pharmaceutical ingredient (API) and finished dosage forms.
• Quality Control & Assurance: Routine testing in QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions.
• Regulatory Submissions: Critical for preparing impurity data packages for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Aids in understanding and optimizing the avanafil synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Avanafil Impurity 34
CAS No.	1202002-16-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound 34; Avanafil Impurity D (Potential); Avanafil EP Impurity D; Avanafil USP Impurity; (2S)-2-[(3-Chloro-4-methoxyphenyl)methylamino]-5-(2-pyrimidinyl)-3,4-dihydro-2H-pyrrol-3-one (Potential IUPAC); STENDRA Impurity; 1202002-16-1
EINECS	Contact for details

Quality Control

Every batch of Avanafil Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 compound is hygroscopic (moisture-sensitive) and should be handled 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.