Otilonium Bromide Impurity 14 CAS 49557-33-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.49557-33-7
Molecular FormulaC28H41N2O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Otilonium Bromide Impurity 14 CAS 49557-33-7 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.

Otilonium Bromide Impurity 14 (CAS 49557-33-7) is a certified pharmaceutical impurity reference standard with the molecular formula C28H41N2O4Br and a molecular weight of 549.55 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution, Otilonium Bromide Impurity 14 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 549.55 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

CATO manufactures Otilonium Bromide Impurity 14 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC28H41N2O4 Br
Molecular Weight549.55 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1971
Halogen ContentBr-containing
Nitrogen Atoms2

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