Tiotropium impurity 47 CAS 4438-38-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.4438-38-4
Molecular FormulaC8H11NO
Molecular Weight137.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tiotropium impurity 47 CAS 4438-38-4 chemical structure

Description

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.

Tiotropium impurity 47 (CAS 4438-38-4) is a certified pharmaceutical impurity reference standard with the molecular formula C8H11NO and a molecular weight of 137.18 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Tiotropium impurity 47 is typically off-white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 137.18 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Tiotropium impurity 47 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 FormulaC8H11NO
Molecular Weight137.18 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms1

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