Lubiprostone Impurity 22 CAS 201341-41-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.201341-41-5
Molecular FormulaC20H34F2O5
Molecular Weight392.48 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lubiprostone Impurity 22 CAS 201341-41-5 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 Lubiprostone Impurity 22.

Lubiprostone Impurity 22 (CAS 201341-41-5) is a certified pharmaceutical impurity reference standard with the molecular formula C20H34F2O5 and a molecular weight of 392.48 g/mol.

Based on its molecular formula C20H34F2O5, Lubiprostone Impurity 22 contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 392.48 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC20H34F2O5
Molecular Weight392.48 g/mol
Purity>95%
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)2014
Halogen ContentF-containing

Related Lubiprostone Standards

Recommended Standards

Why CATO?