Description

Erlotinib D6 Hcl is a deuterated internal standard of the active pharmaceutical ingredient Erlotinib Hydrochloride, essential for precise quantitative analysis in pharmaceutical research and development. This high-purity, isotopically labeled compound is critical for ensuring the accuracy and reliability of mass spectrometry-based bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is a vital tool for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on oncology drug development and quality control.

Application

• Internal Standard for LC-MS/MS: Primary use as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry for the analysis of Erlotinib in biological matrices (plasma, serum, tissue).
• Pharmacokinetic (PK) Studies: Enables accurate measurement of drug concentration over time to determine absorption, distribution, metabolism, and excretion (ADME) profiles.
• Bioequivalence & Bioanalytical Testing: Supports method development and validation for studies comparing generic and innovator drug formulations.
• Drug Metabolism Research: Used in metabolite identification and quantification studies to understand the metabolic pathways of Erlotinib.
• Quality Control in API Manufacturing: Serves as a reference standard for the quality assurance of non-deuterated Erlotinib Hydrochloride active pharmaceutical ingredient (API) batches.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring and dose optimization during clinical trials of Erlotinib-based therapies.

Basic Information

Product Name	Erlotinib D6 Hcl
CAS No.	1189953-78-3
Molecular Formula	C22H17D6ClN3O4 • HCl
Molecular Weight	~ 478.4 g/mol (as hydrochloride salt)
Synonyms	Erlotinib-d6 Hydrochloride; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine-d6 Hydrochloride; Tarceva-d6 HCl; CP-358774-d6 Hydrochloride; OSI-774-d6 HCl; NSC 718781-d6; (3-Ethynylphenyl)[6,7-bis(2-methoxyethoxy)quinazolin-4-yl]amine-d6 Hydrochloride
EINECS	Contact for details

Quality Control

Our Erlotinib D6 Hcl is manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing critical parameters such as isotopic enrichment, chemical purity, and chromatographic profile. We adhere to relevant industry standards for reference materials to guarantee reliable and reproducible performance in your sensitive analytical methods.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D6)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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