Description

Avanafil-13C5,15N is a stable isotope-labeled analog of the active pharmaceutical ingredient Avanafil, specifically enriched with carbon-13 and nitrogen-15 isotopes. This compound serves as a critical internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolism studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies involved in the development and quality control of erectile dysfunction therapeutics.

Application

• Quantitative Bioanalysis: Used as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Avanafil in biological matrices (plasma, serum).
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for studying the absorption, distribution, metabolism, and excretion (ADME) profile of Avanafil in preclinical and clinical research.
• Pharmaceutical Quality Control: Employed in the development and validation of analytical methods for assay and impurity profiling of Avanafil drug substances and products.
• Clinical Research: Supports therapeutic drug monitoring (TDM) and bioequivalence studies to ensure drug safety and efficacy.
• Reference Material: Serves as a certified reference material (CRM) for calibrating analytical instruments and validating testing procedures in GLP/GMP environments.

Basic Information

Product Name	Avanafil-13C5,15N
CAS No.	1276495-36-3
Molecular Formula	C23H21N5O3S (with five 13C and one 15N atoms)
Molecular Weight	Contact for details
Synonyms	Avanafil (13C5,15N); (4-[(3-Chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)pyrrolidin-1-yl]-N-(pyrimidin-2-yl)pyrimidine-5-carboxamide-13C5,15N); STENDRA-13C5,15N; SPEDRA-13C5,15N; 13C5,15N-Labeled Avanafil; Avanafil Isotopic Standard; Avanafil Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Avanafil-13C5,15N is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR (1H, 13C), mass spectrometry, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity (HPLC), isotopic enrichment, and residual solvent content to meet the stringent requirements of pharmaceutical R&D and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥99 atom % 13C; ≥99 atom % 15N
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines

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