Description

Idelalisib D5 is a deuterated isotopologue of the phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor Idelalisib, specifically labeled with five deuterium atoms. This stable isotope-labeled compound is a critical tool for quantitative bioanalytical studies, enabling precise pharmacokinetic and metabolic profiling. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and regulatory submission support.

Application

• Internal Standard for LC-MS/MS: Serves as a high-purity, non-interfering internal standard for the accurate quantification of Idelalisib in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for conducting definitive absorption, distribution, metabolism, and excretion (ADME) studies to understand the drug's fate in the body.
• Bioanalytical Method Development and Validation: Used to develop, optimize, and validate robust, sensitive, and specific analytical methods compliant with FDA and ICH guidelines.
• Clinical and Preclinical Trial Support: Provides reliable data for pharmacokinetic parameters in both animal studies and human clinical trials, ensuring data integrity.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in mass spectrometry-based assays.
• Quality Control in Reference Standard Production: Can be employed as a system suitability or calibration standard in the quality control of unlabeled active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Idelalisib D5
CAS No.	1830330-31-8
Molecular Formula	C22H13D5FN5O
Molecular Weight	~ 419.46 g/mol
Synonyms	5-Fluoro-3-phenyl-2-[(1S)-1-(7H-purin-6-ylamino)propyl]-4(3H)-quinazolinone-d5; GS-1101 D5; CAL-101 D5; Zydelig D5; (S)-2-(1-(9H-Purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one-d5; PI3Kδ Inhibitor D5; Idelalisib (phenyl-d5); Deuterated Idelalisib
EINECS	Contact for details

Quality Control

Our Idelalisib D5 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques, including NMR, HPLC, and mass spectrometry. We ensure compliance with the rigorous standards required for bioanalytical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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