Mirogabalin Impurity 16 CAS 1138245-48-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1138245-48-3
Molecular FormulaC11H20O3
Molecular Weight200.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 16 CAS 1138245-48-3 chemical structure

Description

Mirogabalin Impurity 16 (CAS 1138245-48-3) is a certified pharmaceutical impurity reference standard with the molecular formula C11H20O3 and a molecular weight of 200.27 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Mirogabalin Impurity 16 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 200.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Mirogabalin Impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC11H20O3
Molecular Weight200.27 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1989

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