Description

Erlotinib 13C6 Hcl is a stable isotope-labeled analog of the tyrosine kinase inhibitor Erlotinib, where six carbon atoms are replaced with the 13C isotope. This compound is an essential internal standard for the precise quantification of Erlotinib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development. The use of this labeled standard ensures high accuracy and reliability in data critical for regulatory submissions and clinical research.

Application

• Bioanalytical Method Development and Validation: Serves as a critical internal standard for developing and validating sensitive and specific LC-MS/MS methods for Erlotinib quantification.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of Erlotinib concentration in plasma, serum, and tissue samples to study absorption, distribution, metabolism, and excretion (ADME).
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Erlotinib.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring (TDM) and dose optimization studies in oncology clinical trials.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized as a reference standard in impurity profiling and assay development for Erlotinib active pharmaceutical ingredient (API).
• Forensic and Anti-Doping Analysis: Acts as a definitive standard in confirmatory testing where precise identification and quantification of Erlotinib are required.

Basic Information

Product Name	Erlotinib 13C6 Hcl
CAS No.	1210610-07-3
Molecular Formula	C2213C6H24ClN3O4 • HCl
Molecular Weight	~ 435.9 g/mol (for 13C6 labeled form)
Synonyms	Erlotinib-13C6 Hydrochloride; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine-13C6 Hydrochloride; CP-358774-13C6 HCl; OSI-774-13C6 HCl; Tarceva-13C6 Internal Standard; [13C6]-Erlotinib HCl; Stable Isotope Labeled Erlotinib HCl
EINECS	Contact for details

Quality Control

Our Erlotinib 13C6 Hcl is manufactured under strict quality control protocols to ensure the highest isotopic and chemical purity for demanding analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing key parameters such as isotopic enrichment, chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant industry guidelines for reference standards. Certificates of Analysis (COA) are available upon request.

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). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Isotopic Enrichment	≥ 99 atom % 13C
Chemical Purity (HPLC)	≥ 98.0%
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.