Sucralose Impurity 2 CAS 475491-24-8

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.475491-24-8
Molecular FormulaC12H19F3O8
Molecular Weight348.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sucralose Impurity 2 CAS 475491-24-8 chemical structure

Description

Sucralose Impurity 2 (CAS 475491-24-8) is a certified pharmaceutical impurity reference standard with the molecular formula C12H19F3O8 and a molecular weight of 348.27 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, Sucralose Impurity 2 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 348.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Sucralose Impurity 2 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 FormulaC12H19F3O8
Molecular Weight348.27 g/mol
Purity>90%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)2025
Halogen ContentF-containing

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