Hyoscine Butylbromide EP Impurity C Bromide CAS 155-41-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.155-41-9
Molecular FormulaC18H24NO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Hyoscine Butylbromide EP Impurity C Bromide CAS 155-41-9 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 Hyoscine Butylbromide EP Impurity C Bromide.

CATO supplies Hyoscine Butylbromide EP Impurity C Bromide (CAS 155-41-9), a pharmacopoeial impurity reference standard (molecular formula C18H24NO4Br, MW 398.30 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Hyoscine Butylbromide EP Impurity C Bromide (C18H24NO4Br) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 398.30 g/mol, it falls into the moderately-high-molecular-weight range. 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 FormulaC18H24NO4 Br
Molecular Weight398.30 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentBr-containing
Nitrogen Atoms1

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