Roflumilast Impurity 11 CAS CATO-C4X-204711

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-204711
Molecular FormulaC22H28Cl2N2O8S2
Molecular Weight583.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roflumilast Impurity 11 CAS CATO-C4X-204711 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.

CATO supplies Roflumilast Impurity 11 (CAS CATO-C4X-204711), a pharmacopoeial impurity reference standard (molecular formula C22H28Cl2N2O8S2, MW 583.50 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Roflumilast Impurity 11 (C22H28Cl2N2O8S2) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 583.50 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).

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 FormulaC22H28Cl2N2O8S2
Molecular Weight583.50 g/mol
Purity≥95%
StorageStore in a cool place (≤25°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2
Sulfur Atoms2

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