Indacaterol Maleate Related Compounds & Impurities

Indacaterol Maleate is an ultra-long-acting beta-2 agonist (LABA) bronchodilator used as a once-daily inhaler for COPD maintenance.

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 Indacaterol Maleate reference standards, pharmacopeial and non-pharmacopeial Indacaterol Maleate 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 Indacaterol Maleate-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

Indacaterol Maleate
Indacaterol
Indacaterol Impurity 16
Keto Chloro Impurity
8-Hydroxy-2(1H)-quinolinone
O-benzyl Acetyl
Indacaterol Impurity 13 Hydrochloride
Indacaterol S- Isomer Impurity Hydrochloride
Benzyl Indacaterol
Indacaterol Impurity A
Indacaterol Impurity B
Indacaterol Impurity 2
Indacaterol Mono Ethyl Impurity
5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-ethoxyethyl]-8-hydroxy-2(1H)-quinolinone
Indacaterol Impurity 4
Indacaterol Impurity 8
Indacaterol Impurity 2
Indacaterol Impurity 1
5,6-Diethyl-2,3-Dihydro-1H-Inden-1-one
Indacaterol Oxo Impurity
((R)-5-(2-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-ethoxyethyl)-8- hydroxyquinolin-2(1H)-one)
Indacaterol Acetate R-Isomer
5-(2-((5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino)-1-ethoxyethyl)-8-hydroxyquinolin-2(1H)-one
Indacaterol Impurity 12
Indacaterol Impurity 14
[(R)-8-(benzyloxy)-5-(2-bromo-1-((tert-butyl dimethylsilyl) oxy) ethyl) quinolin-2(1H)-one]
O-Benzyl Indacaterol 2,3-dihydroxy Succinate
Indacaterol Maleate Impurity 37
Indacaterol Nitroso Impurity
N-Nitroso O-Benzyl Indacaterol
Indacaterol Nitroso Impurity 2
N-Nitroso Indacaterol Mono Ethyl Impurity
Indacaterol Impurity 17
Indacaterol S- Isomer Impurity
Indacaterol Maleate Racemate Impurity
Indacaterol Impurity 11 Hydrochloride
Benzyl Indacaterol Succinate S-Isomer
Indacaterol Formate
Oxo-indacaterol
Indacaterol Impurity 31
Indacaterol Impurity 30
Indacaterol Impurity 11
Indacaterol Mono Ethyl Impurity Maleate Salt
Indacaterol Impurity 9
Indacaterol Impurity 10
Indacaterol Impurity 15
Indacaterol Impurity 13
Indacaterol Impurity 38
Indacaterol Debenzyl Hydroxy Impurity
Indacaterol Impurity 24
Indacaterol Impurity 25
Indacaterol Impurity 26
Indacaterol Impurity 5
Indacaterol Impurity 6
Indacaterol Impurity 7
Indacaterol Impurity 18
Indacaterol Impurity 19
Indacaterol Impurity 1
Indacaterol Impurity 3
Indacaterol Impurity 20
Indacaterol Impurity 21
Indacaterol Impurity 22
Indacaterol Impurity 23
Indacaterol Impurity 27
Indacaterol Impurity 28
Indacaterol Impurity 29
Indacaterol Impurity 32
Indacaterol Regio Isomer
N-Methyl Indacaterol Impurity
(2-(Methylamino)pyridin-3-yl)methyl 2-((tert-Butoxycarbonyl)(methyl)amino)acetate

Metabolites

Indacaterol 8-O-Glucuronide Sodium Salt
Indacaterol metabolite P37

Isotope Labelled Compounds

Indacaterol-D3
[13C4]-Indacaterol Acetate Salt