Trospium Impurity N1 CAS 99945-31-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.99945-31-0
Molecular FormulaC11H20NO
Molecular Weight182.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trospium Impurity N1 CAS 99945-31-0 chemical structure

Description

Trospium Impurity N1 (CAS 99945-31-0) is a certified pharmaceutical impurity reference standard with the molecular formula C11H20NO and a molecular weight of 182.28 g/mol.

Structurally, Trospium Impurity N1 (C11H20NO) contains an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.5, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 182.28 g/mol, it falls into the medium-molecular-weight range. 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.

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 FormulaC11H20NO
Molecular Weight182.28 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.5
CAS Registry Year (est.)1985
Nitrogen Atoms1

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