N-Nitroso Tolterodine EP Impurity E CAS 2680528-95-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2680528-95-2
Molecular FormulaC19H24N2O2
Molecular Weight312.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Tolterodine EP Impurity E CAS 2680528-95-2 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including N-Nitroso Tolterodine EP Impurity E.

N-Nitroso Tolterodine EP Impurity E (CAS 2680528-95-2) is a certified pharmaceutical impurity reference standard with the molecular formula C19H24N2O2 and a molecular weight of 312.41 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, N-Nitroso Tolterodine EP Impurity E is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 312.41 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), N-Nitroso Tolterodine EP Impurity E 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 FormulaC19H24N2O2
Molecular Weight312.41 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2002
Nitrogen Atoms2

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