Lubiprostone impurity 7 CAS CATO-C4X-11367

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-11367
Molecular FormulaC20H32F2O5
Molecular Weight390.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lubiprostone impurity 7 CAS CATO-C4X-11367 chemical structure

Description

CATO supplies Lubiprostone impurity 7 (CAS CATO-C4X-11367), a pharmacopoeial impurity reference standard (molecular formula C20H32F2O5, MW 390.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Lubiprostone impurity 7 (C20H32F2O5) contains a steroid core, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 390.46 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC20H32F2O5
Molecular Weight390.46 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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