Salbutamol EP Impurity D HCl(R-Isomer) CAS CATO-C4X-1176199

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1176199
Molecular FormulaC13H19NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Salbutamol EP Impurity D HCl(R-Isomer) CAS CATO-C4X-1176199 chemical structure

Description

The occurrence of Salbutamol EP Impurity D HCl(R-Isomer) is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Salbutamol EP Impurity D HCl(R-Isomer) (CAS CATO-C4X-1176199) is a certified pharmaceutical impurity reference standard with the molecular formula C13H19NO3HCl and a molecular weight of 273.76 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Salbutamol EP Impurity D HCl(R-Isomer) is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 273.76 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

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 FormulaC13H19NO3 HCl
Molecular Weight273.76 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, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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