Formoterol EP Impurity I (Enantiomer Mixture) CAS 532414-36-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.532414-36-1
Molecular Formula2*C19H24N2O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Formoterol EP Impurity I (Enantiomer Mixture) CAS 532414-36-1 chemical structure

Description

As a process- or degradation-related impurity, Formoterol EP Impurity I (Enantiomer Mixture) (CAS 532414-36-1, C19H24N2O4) 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, Formoterol EP Impurity I (Enantiomer Mixture) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 344.41 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Formoterol EP Impurity I (Enantiomer Mixture) 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 Formula2*C19H24N2O4
Molecular Weight344.41 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1984
Nitrogen Atoms2

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