Salbutamol EP Impurity O TFA salt CAS 2387728-91-6(Free Base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2387728-91-6(Free Base)
Molecular FormulaC15H25NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Salbutamol EP Impurity O TFA salt CAS 2387728-91-6(Free Base) chemical structure

Description

Salbutamol EP Impurity O TFA salt (CAS 2387728-91-6(Free Base)) is a certified pharmaceutical impurity reference standard with the molecular formula C15H25NO3C2HF3O2 and a molecular weight of 381.39 g/mol.

Based on its molecular formula C15H25NO3C2HF3O2, Salbutamol EP Impurity O TFA salt contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 381.39 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC15H25NO3 C2HF3O2
Molecular Weight381.39 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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