Suvorexant Impurity 8 CAS CATO-C4X-18128

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-18128
Molecular FormulaC22H28ClN3O4
Molecular Weight433.93 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Suvorexant Impurity 8 CAS CATO-C4X-18128 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 Suvorexant Impurity 8.

As a process- or degradation-related impurity, Suvorexant Impurity 8 (CAS CATO-C4X-18128, C22H28ClN3O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Suvorexant Impurity 8 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 433.93 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC22H28ClN3O4
Molecular Weight433.93 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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