Mirogabalin Related Compounds & Impurities

Mirogabalin is an alpha-2-delta ligand with preferential binding to the delta-1 subunit, developed for neuropathic pain in Asian markets.

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 Mirogabalin reference standards, pharmacopeial and non-pharmacopeial Mirogabalin 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 Mirogabalin-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

Mirogabalin Besylate
Rac-Mirogabalin Benzene Sulphonic Acid Salt
Mirogabalin
Mirogabalin Impurity 8
Mirogabalin Impurity 7
Mirogabalin Impurity 11
Mirogabalin Impurity 12
Mirogabalin Impurity 15
Mirogabalin Impurity 4
Mirogabalin Impurity 3
Mirogabalin Impurity 5
Mirogabalin Dimer Impurity
Mirogabalin Impurity 17
Mirogabalin Impurity 20
Mirogabalin Impurity 21
Mirogabalin Impurity 21 Hydrochloride
Mirogabalin Impurity 22
Mirogabalin Impurity 25
Mirogabalin Impurity 18
Mirogabalin Impurity 19
Mirogabalin Impurity 2
Mirogabalin Impurity 23
Mirogabalin Impurity 24
Mirogabalin Impurity 13
Mirogabalin Trifluoroacetate Impurity
Mirogabalin Impurity 1
Mirogabalin mpurity 6
Mirogabalin Impurity 10
Mirogabalin Impurity 14
Mirogabalin Impurity 16
Mirogabalin Impurity 26
Mirogabalin Nitroso Impurity 1
Mirogabalin Nitroso Impurity 2
Mirogabalin Impurity 9
Mirogabalin Impurity 6
Mirogabalin Impurity 27
Mirogabalin Impurity 28
Mirogabalin Impurity 29
Mirogabalin Impurity 32
Mirogabalin Impurity 30
Mirogabalin trifluoroacetate Impurity 1
Mirogabalin Impurity 31
Mirogabalin Impurity 8 Tosylate

Metabolites

Mirogabalin N-Glucuronide
Mirogabalin Acyle Glucuronide
Mirogabalin Lactam

Isotope Labelled Compounds

Mirogabalin Besylate D5
Mirogabalin-15N,D2
Mirogabalin-13C2 D1 (Mixture of Diastereomers)