Dabigatran Impurity 96 CAS 16156-50-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.16156-50-6
Molecular FormulaC7H16O3S
Molecular Weight180.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity 96 CAS 16156-50-6 chemical structure

Description

The molecular framework of Dabigatran Impurity 96 (C7H16O3S) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development.

As a process- or degradation-related impurity, Dabigatran Impurity 96 (CAS 16156-50-6, C7H16O3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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), Dabigatran Impurity 96 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 FormulaC7H16O3S
Molecular Weight180.27 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1961
Sulfur Atoms1

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