Topiramate Impurity 8 CAS 912456-61-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.912456-61-2
Molecular FormulaC9H16O6
Molecular Weight220.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Topiramate Impurity 8 CAS 912456-61-2 chemical structure

Description

The occurrence of Topiramate Impurity 8 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Topiramate Impurity 8 (CAS 912456-61-2) is a certified pharmaceutical impurity reference standard with the molecular formula C9H16O6 and a molecular weight of 220.22 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Topiramate Impurity 8 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 220.22 g/mol — guide the selection of appropriate sample preparation and analytical techniques.

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), Topiramate Impurity 8 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 FormulaC9H16O6
Molecular Weight220.22 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.)1987

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