Erlotinib Related Compounds & Impurities

Erlotinib is a reversible EGFR tyrosine kinase inhibitor used for EGFR mutation-positive non-small cell lung cancer and pancreatic cancer.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Erlotinib reference standards, pharmacopeial and non-pharmacopeial Erlotinib impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Erlotinib-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Erlotinib Hydrochloride
Erlotinib
Erlotinib Impurity-(3-Ethynylaniline)
Erlotinib Chloro Impurity
Erlotinib Hydrochloride Impurity 3
Erlotinib Impurity 8
Erlotinib Impurity M
1-(3-Aminophenyl)ethanone
Erlotinib Impurity 27
Erlotinib Lactam Impurity
Erlotinib Impurity D
Erlotinib impurity E
Erlotinib Impurity 11
Erlotinib Impurity 18
Erlotinib Impurity 2
Erlotinib Impurity 14
Erlotinib Impurity 23
Didesmethyl Erlotinib Hydrochloride Salt
N-Methoxyethyl Erlotinib Hydrochloride
N-Methoxyethyl Erlotinib
3-butyn-2-ol, 4-[3-[[6,7-bis(2-methoxyethoxy)-4-quinazolinyl]amine]phenyl]-2-methyl, hydrochloride
Erlotinib Isopropyl Ether
3-Bromo-Erlotinib Hydrochloride
Erlotinib Dimer 2
Erlotinib Chloroethene Impurity Hydrochloride
ethyl2-amino-4-(2-hydroxyethoxy)-5-(2-methoxyethoxy)benzoate-
ethyl2-amino-5-(2-hydroxyethoxy)-4-(2-methoxyethoxy)benzoate
2-Ethynylaniline
4-Ethynylaniline
2-((4-amino-7-(2-methoxyethoxy)quinazolin-6-yl)oxy)ethanol
Erlotinib Impurity 35
Erlotinib Chloroethene Impurity
Desmethyl Erlotinib
7-(2`-Desmethyl) Erlotinib
Erlotinib Impurity 4
Erlotinib 7-O-Chloroethyl Analog
Erlotinib Impurity 1
Erlotinib Impurity 2
Erlotinib-3-Vinyl Hydrochloride
Desmethyl Erlotinib Acetate
Erlotinib
Erlotinib Impurity 33
7-O-Desmethoxy-7-O-chloroethyl Erlotinib
3-Ethynylaniline hydrochloride
Erlotinib Amine Impurity
4-Methyl Erlotinib
Erlotinib Impurity 5
4-(3-Aminophenyl)-2-methylbutan-2-ol
N-(4-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine
N-(2-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine
Tetrahydro Erlotinib
4-(3-((6,7-bis(2-methoxyethoxy)quinazolin-4-yl)amino)phenyl)-2-methylbutan-2-ol
4-(3-Aminophenyl)-2-methylbutan-2-ol
Erlotinib Impurity 10
Erlotinib Impurity C
Erlotinib Impurity F
Erlotinib Impurity 6
Erlotinib Impurity 13
Erlotinib Hydrochloride Form-B
Erlotinib Nitroso Impurity
6,7-Bis(2-Methoxyethoxy)-N-(3-ethylphenyl)-N-(2-methoxyethyl)quinazolin-4-amine
3-Vinyl Erlotinib
Erlotinib Impurity 31
Erlotinib Acetate
Erlotinib Impurity 52
Erlotinib Impurity 1 Hydrochloride Salt
Erlotinib Impurity 7
Erlotinib Impurity 9 Hydrochloride
Erlotinib Impurity 12

Metabolites

Erlotinib O-Desmethyl Metabolite Isomer
Erlotinib Didesmethyl
Erlotinib Hydroxy Metabolite
Erlotinib Carboxylic Acid

Isotope Labelled Compounds

Erlotinib-D6 Hydrochloride
Erlotinib 13C6 Hydrochloride
3-Ethynylaniline-D4