Asenapine Related Compounds & Impurities

Asenapine is an atypical antipsychotic with broad multi-receptor antagonism administered sublingually for schizophrenia and bipolar mania.

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 Asenapine reference standards, pharmacopeial and non-pharmacopeial Asenapine 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 Asenapine-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

Asenapine Maleate
Asenapine N-Oxide
N-Desmethyl Asenapine Hydrochloride
2,3-Dihydro-1-oxo Asenapine
Asenapine-Nbeta-D-Glucuronide
Deschloro Asenapine
Cis-Asenapine
Asenapine Tetradehydro Impurity
Asenapine Amide Impurity
Asenapine Impurity ASE 02
Asenapine Impurity ASE 01
Asenapine Impurity ASE 04
Asenapine Impurity ASE 11
Asenapine Impurity 8
Asenapine Impurity 9
Asenapine Impurity 10
Trans-2-Nitroso-5-nitro-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7] oxepino [4,5-c]-pyrrole
Trans-2-Nitroso-5-amino-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole
Trans-2-Nitroso-5-chloro-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole
Asenapine 11-Sulfate Impurity
Asenapine Impurity 22
Asenapine Impurity 3
Asenapine Impurity 2
Asenapine Impurity 1
Asenapine N-Oxide Impurity 1
Asenapine Maleate (RS Isomer)
Asenapine N-Oxide Impurity 2
Asenapine Impurity 4
Asenapine Impurity 5
Asenapine Impurity 6
Asenapine Impurity 7
Asenapine Impurity 11
Asenapine Impurity 12
Asenapine Impurity 13

Isotope Labelled Compounds

Asenapine-13C-D3 Hydrochloride