Description

Avanafil Impurity 36 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 through rigorous quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The precise characterization of this impurity is essential for compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of Avanafil Impurity 36 in avanafil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) to agencies like the US FDA, EMA, and other global health authorities.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in the routine QC testing of commercial API batches to ensure specification compliance.
• Research & Development: Used in R&D to study the chemical and metabolic pathways of avanafil and to synthesize impurity for toxicological studies.

Basic Information

Product Name	Avanafil Impurity 36
CAS No.	2250243-09-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avanafil Related Compound 36; Avanafil Impurity C; Avanafil EP Impurity C; (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)-1-pyrrolidinyl)-N-(2-pyrimidinylmethyl)pyrimidine-5-carboxamide; UNII-5T0I4F4Z4I; 5T0I4F4Z4I; STAVZ-IMP-36
EINECS	Contact for details

Quality Control

Our Avanafil Impurity 36 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity, ensuring compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and related substance profile, is provided with every shipment.

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 under an inert atmosphere if specified for long-term storage.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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