Erlotinib EP Impurity H

Erlotinib in combination with capecitabine and docetaxel in patients with metastatic breast cancer: A dose-escalation study
Chris Twelvesa, Jose´ M. Trigob , Rob Jonesc , Flavio De Rosad , Ashok Rakhite , Scott Fettnere , Tonya Wrightc , Jose´ Baselga
European journal of cancer 44 (2008) 419 – 426
 
Development and validation of a stability indicating HPLC method for the quantification of impurities in Erlotinib hydrochloride dosage forms
BabuC1, Narasimha  RaoK.L1,  DevannaN1, Suresh Reddy  K.V.N
 
Solubility Measurement and Correlation of Two Erlotinib Hydrochloride Polymorphs in Alcohols and Ketones from 273.15 to 323.15 K
Jinghuan Zhai, Junrui Zhao, Zhenzhen Chen, Changwei Xiao, Xijian Liu, Lijuan Zhang, and Jie Lu
J. Chem. Eng. Data 2017, 62, 1, 516–524
 
Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector
Chandrashekara KARUNAKARA, Udupi APARNA, Venkateshappa CHANDREGOWDA, and Chandrasekara G. REDDY
Analytical Sciences 28(3):305-8
 

Erlotinib EP Impurity H is chemically 7-(2-Chloroethoxy)-N-(3-ethynylphenyl)-6-(2-methoxyethoxy)quinazolin-4-amine hydrochloride (as per EP). It is also known as Erlotinib 7-O-Chloroethyl Analog. Erlotinib EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Erlotinib EP Impurity H can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Erlotinib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.