Lapatinib Related Compounds & Impurities

Lapatinib is a dual EGFR/HER2 tyrosine kinase inhibitor used in combination therapy for HER2-positive metastatic breast 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 Lapatinib reference standards, pharmacopeial and non-pharmacopeial Lapatinib 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 Lapatinib-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

Lapatinib Ditosylate
Lapatinib
Lapatinib Impurity 5
Lapatinib Ditosylate
Lapatinib Impurity C
4-Chloro-6-iodoquinazoline
Lapatinib Ditosylate Hydrate IP Impurity B
Deschloro Lapatinib
Lapatinib Impurity 3
Lapatinib Impurity 2
Lapatinib Impurity 15
Lapatinib Impurity 19
N-(4-(benzyloxy)phenyl)-6-(5-(((2-(methylsulfonyl) ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine hydrochloride
Lapatinib 2-Fluoro Analog
Lapatinib 4-Fluoro Analog
N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-iodoquinazolin-4-amine hydrochloride
Lapatinib Impurity 7
Lapatinib Impurity 6
Lapatinib Impurity 16
Lapatinib Impurity 1
Selatinib
Lapatinib Ditosylate Monohydrate
Lapatinib Nitroso Impurity 1
Lapatinib Nitroso Impurity 2
Lapatinib Impurity 24
Lapatinib 4-Fluoro Analog bis(4-methylbenzenesulfonate)
Lapatinib 2-Fluoro Analog bis(4-methylbenzenesulfonate)
Lapatinib Nitroso Impurity 3

Isotope Labelled Compounds

Lapatinib D4 Ditosylate