Isosorbide Impurity 21 CAS 28218-55-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.28218-55-5
Molecular FormulaC6H12O5
Molecular Weight164.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isosorbide Impurity 21 CAS 28218-55-5 chemical structure

Description

The occurrence of Isosorbide Impurity 21 is closely related to a carbohydrate-derived structure in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Isosorbide Impurity 21 (CAS 28218-55-5, C6H12O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Isosorbide Impurity 21 (C6H12O5) contains a carbohydrate-derived structure. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions.

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), Isosorbide Impurity 21 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 FormulaC6H12O5
Molecular Weight164.16 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)1.0
CAS Registry Year (est.)1965

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