Bromhexine EP Impurity E CAS 1660957-93-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1660957-93-6
Molecular FormulaC15H21Br2N2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bromhexine EP Impurity E CAS 1660957-93-6 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 Bromhexine EP Impurity E.

Bromhexine EP Impurity E (CAS 1660957-93-6) is a certified pharmaceutical impurity reference standard with the molecular formula C15H21Br2N2Cl and a molecular weight of 424.60 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine/bromine substitution, Bromhexine EP Impurity E is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 424.60 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Bromhexine EP Impurity E meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC15H21Br2N2 Cl
Molecular Weight424.60 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Halogen ContentCl/Br-containing
Nitrogen Atoms2

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