Osimertinib Mesylate Related Compounds & Impurities

Osimertinib Mesylate is a tyrosine kinase inhibitor used in targeted oncology therapy.

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 Osimertinib Mesylate reference standards, pharmacopeial and non-pharmacopeial Osimertinib Mesylate 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 Osimertinib Mesylate-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

Osimertinib Impurity A
Osimertinib Impurity I
Osimertinib Impurity J
Osimertinib Dimer 1
Osimertinib Dimer Impurity 3
Osimertinib Impurity Q
Osimertinib Methoxy Impurity
Osimertinib N- methylacrylamide Impurity
Osimertinib Impurity G
Osimertinib Amine Impurity
Osimertinib 2-Amide Impurity
Osimertinib Acetyl Impurity
Osimertinib Dimer Impurity 4chloride
Osimertinib Impurity M
Osimertinib Beta-lactam Impurity silicon dioxide
Osimertinib Impurity 11
3,3`-(Pyrimidine-2,4-diyl)bis(1-methyl-1H-indole)
3-(4-Chloropyrimidin-2-yl)-1-methyl-1H-indole
Osimertinib Impurity 14
4-FIuoro-2-methoxy-6-nitroaniIine
Osimertinib Impurity 9
Osimertinib Beta-lactam Impurity
Osimertinib Impurity 27
N-(4-Fluoro-2-methoxyphenyl)acetamide
N-(4-Fluoro-2-methoxy-5-nitrophenyl)acetamide
Osimertinib Impurity 8
Osimertinib Methoxy Impurity Mesylate
Osimertinib Impurity 28
Osimertinib N-Oxide
Osimertinib Impurity 29
Osimertinib Impurity 30
Osimertinib Impurity 31
Osimertinib Impurity 32
Osimertinib N Desmethyl Impurity
Osimertinib Impurity 22
N-Acryloyl Osimertinib
Osimertinib N Desmethyl Impurity
N-Desmethyl Osimertinib Impurity
O-Desmethyl Osimertinib Impurity
Osimertinib Dimer Impurity 4
Osimertinib Dimer Impurity 5
Osimertinib Impurity 33
Osimertinib Impurity 34
Osimertinib Impurity 35
Osimertinib Impurity 36
Osimertinib Impurity 37
Osimertinib N-Nitroso N Desmethyl Impurity
Osimertinib Nitroso Impurity 3
Osimertinib
Osimertinib Mesylate Form B
Osimertinib Impurity 1
Osimertinib Nitroso Impurity 1
Osimertinib Nitroso Impurity 2
Osimertinib Impurity 2
Osimertinib Impurity 4
Osimertinib Impurity 5
Osimertinib Impurity 6
Osimertinib Impurity 7
Osimertinib Impurity 10
Osimertinib Impurity 12
Osimertinib Nitroso Impurity 4
Osimertinib Nitroso Impurity 5
Osimertinib Nitroso Impurity 6
Osimertinib Nitroso Impurity 7
Osimertinib Nitroso Impurity 8
Osimertinib Nitroso Impurity 9
Osimertinib Nitroso Impurity 10
N-Nitroso Osimertinib Aminomethoxy Impurity
Osimertinib N-N DiNitroso Impurity 1
Osimertinib Nitroso Impurity 11
Osimertinib Nitroso Impurity 12
Osimertinib Nitroso Impurity 13
N-Nitroso Osimertinib Chloro Impurity
Osimertinib Impurity 13
Osimertinib Impurity 15
Osimertinib Impurity 16
Osimertinib Nitroso Impurity 14
Osimertinib Impurity 17
Osimertinib Dimer Impurity 1
N-Nitroso Osimertinib N-Oxide Impurity
N-Nitroso Osimertinib Chloro Impurity 1
Osimertinib Impurity 18
Osimertinib Dimer Impurity 4 Trifluoroacetate
Osimertinib Impurity 19
Osimertinib Impurity 20
Osimertinib Impurity 21

Isotope Labelled Compounds

Osimertinib-13CD3