Description

Tadalafil-D3 CAS NO 960226-55-5 is a deuterium-labeled analog of the active pharmaceutical ingredient Tadalafil, specifically designed for use as an internal standard in analytical chemistry. This high-purity, isotopically labeled compound is critical for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments requiring precise measurement of Tadalafil in complex biological matrices.

Application

• Primary use as an Internal Standard (IS) in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) methods.
• Quantitative analysis of Tadalafil in pharmacokinetic studies to determine drug absorption, distribution, metabolism, and excretion (ADME).
• Essential for bioanalytical method development and validation in support of regulatory filings (e.g., FDA, EMA).
• Use in drug metabolism and stability studies to track and quantify the parent compound.
• Quality control and impurity profiling in the manufacturing of active pharmaceutical ingredients (APIs).
• Reference material for forensic and anti-doping laboratories analyzing for the presence of phosphodiesterase type 5 (PDE5) inhibitors.

Basic Information

Product Name	Tadalafil-D3
CAS No.	960226-55-5
Molecular Formula	C22H16D3N3O4
Molecular Weight	392.41 g/mol
Synonyms	(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione-d3; Cialis-d3; Deuterated Tadalafil; Tadalafil (methyl-d3); Tadalafil Internal Standard; ADCIRCA-d3; IC-351-d3
EINECS	Contact for details

Quality Control

Our Tadalafil-D3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for chemical purity and isotopic enrichment, NMR for structural confirmation, and mass spectrometry for identity verification. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, isotopic purity (typically >98 atom % D), and residual solvent analysis. Our quality commitment ensures the material meets the stringent requirements for use in GLP and GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95% (by NMR)
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 1.0%

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