Description

Osimertinib-13Cd3 is a stable isotope-labeled analog of the third-generation EGFR tyrosine kinase inhibitor, Osimertinib, where three hydrogen atoms are replaced by deuterium (²H or D) at the 13C position. This compound is an essential internal standard for the precise and accurate quantification of Osimertinib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and bioanalytical facilities engaged in pharmacokinetic studies, drug metabolism research, and clinical trial support.

Application

• Bioanalytical Internal Standard: Serves as a critical reference compound for the quantitative LC-MS/MS analysis of Osimertinib in plasma, serum, and tissue samples.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables reliable measurement of drug concentration-time profiles to assess absorption, distribution, metabolism, and excretion (ADME).
• Clinical Trial Support: Used in regulated bioanalysis to generate robust data for regulatory submissions to agencies like the FDA and EMA.
• Drug Metabolism and Disposition Research: Facilitates the study of metabolite profiling and the metabolic stability of Osimertinib.
• Method Development and Validation: Essential for developing, optimizing, and validating sensitive and specific analytical methods in compliance with GLP guidelines.
• Quality Control in Manufacturing: Can be employed as a standard for assessing the purity and consistency of Osimertinib active pharmaceutical ingredient (API) batches.

Basic Information

Item	Details
Product Name	Osimertinib-13Cd3
CAS No.	2254100-49-5
Molecular Formula	C28H30N7O2-13Cd3
Molecular Weight	Contact for details
Synonyms	AZD-9291-13Cd3; Tagrisso-13Cd3; N-(2-{[2-(Dimethylamino)ethyl](methyl)amino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide-13Cd3; Osimertinib-d3; Deuterated Osimertinib; EGFR TKI Inhibitor-13Cd3; (E)-N-(2-((2-(Dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide-13Cd3
EINECS	Contact for details

Quality Control

Our Osimertinib-13Cd3 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive mass spectrometry applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, assay, isotopic enrichment, and impurity profiles. We adhere to relevant industry standards for reference materials, and our quality commitment supports compliance in GLP and GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, consider storing under an inert atmosphere. Allow the vial to warm to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (LC-MS)	≥99.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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