N-Nitroso Atropine EP Impurity B CAS 55855-45-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.55855-45-3
Molecular FormulaC16H20N2O4
Molecular Weight304.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Atropine EP Impurity B CAS 55855-45-3 chemical structure

Description

Based on its molecular formula C16H20N2O4, N-Nitroso Atropine EP Impurity B contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 304.34 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

As a process- or degradation-related impurity, N-Nitroso Atropine EP Impurity B (CAS 55855-45-3, C16H20N2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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), N-Nitroso Atropine EP Impurity B 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 FormulaC16H20N2O4
Molecular Weight304.34 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°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
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Nitrogen Atoms2

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