Tiotropium Impurity 28 CAS 59516-66-4

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.59516-66-4
Molecular FormulaC4H2O7
Molecular Weight162.05 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tiotropium Impurity 28 CAS 59516-66-4 chemical structure

Description

The occurrence of Tiotropium Impurity 28 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, Tiotropium Impurity 28 (CAS 59516-66-4, C4H2O7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carbohydrate-derived structure, Tiotropium Impurity 28 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 162.05 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC4H2O7
Molecular Weight162.05 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>90%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1974

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