Description

Osi-420-D4, Free Base (Desmethyl Erlotinib-D4) is a deuterium-labeled analog of a key metabolite of the tyrosine kinase inhibitor Erlotinib. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and analytical research.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of Desmethyl Erlotinib in complex biological matrices like plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of Erlotinib.
• Bioanalytical Method Development and Validation: Serves as a reference compound to establish selective, sensitive, and robust analytical assays compliant with FDA and EMA guidelines.
• Clinical Research: Enables accurate therapeutic drug monitoring (TDM) and pharmacokinetic profiling in clinical trial samples.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-precision analytical techniques to minimize matrix effects and improve data quality.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of metabolite-related impurities in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	Osi-420-D4, Free Base (Desmethyl Erlotinib-D4)
CAS No.	1216420-11-9
Molecular Formula	C₂₁H₁₉D₄N₃O₄
Molecular Weight	377.45 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine-d4; Desmethyl Erlotinib-d4; CP-358774-d4; OSI-420-d4; Tarceva Metabolite-d4; NSC-718781-d4; EGFR Inhibitor Metabolite-d4
EINECS	Contact for details

Quality Control

Every batch of Osi-420-D4, Free Base is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of critical unlabeled impurities. Our quality commitment ensures the material meets the stringent requirements for regulated bioanalysis.

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 to ensure stability.

Specification

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

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