Description

Ibrutinib D5 CAS NO 1553977-17-5 is a deuterated isotopologue of the potent and selective Bruton's tyrosine kinase (BTK) inhibitor, Ibrutinib. This stable-labeled compound is a critical tool for quantitative bioanalytical studies, enabling precise pharmacokinetic and metabolic profiling without interference from endogenous compounds. 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 Analysis: Serves as a reliable internal standard for the accurate quantification of Ibrutinib and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Essential for conducting definitive absorption, distribution, metabolism, and excretion (ADME) studies in preclinical and clinical research.
• Drug Metabolism Research: Used to investigate metabolic pathways and identify metabolites, aiding in the understanding of drug efficacy and safety profiles.
• Bioequivalence and Biosimilar Studies: Provides the high-precision measurement required for comparative studies between drug formulations.
• Regulatory Compliance and Submission: Supports data packages submitted to regulatory bodies (e.g., FDA, EMA) by ensuring analytical method validity and result accuracy.

Basic Information

Product Name	Ibrutinib D5
CAS No.	1553977-17-5
Molecular Formula	C25H19D5N6O2
Molecular Weight	443.53 g/mol
Synonyms	PCI-32765 D5; 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one-d5; (R)-1-(3-(4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one-d5; Deuterated Ibrutinib; Ibrutinib-d5; BTK Inhibitor D5
EINECS	Contact for details

Quality Control

Every batch of Ibrutinib D5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment meet the stringent requirements for mass spectrometry applications. We provide comprehensive Certificates of Analysis (COA) detailing specifications for chemical purity, isotopic purity (D-enrichment), and residual solvents. Our quality system is designed to support GLP/GMP-compliant research, ensuring data integrity and reliability for critical studies.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (H-NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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