Salbutamol EP Impurity J (Free Base)
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156547-62-5Salbutamol EP Impurity J (Free Base)

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Catalogue No.:VE009765
CAS No.:156547-62-5
Mol. Formula:C13H19NO3
Mol. Weight:237.29 g/mol

Additional information on CAS 156547-62-5

Parent drug

Salbutamol

IUPAC Name

2-(tert-Butylamino)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone

Pharmacopoeial Synonyms

Salbutamol BP Impurity J / Albuterol Related Compound B

Other Synonyms

Salbutamone; Salbutamol ketone impurity ;Albuterone;2-((1,1-Dimethylethyl)amino)-1-(4-hydroxy-3-(hydroxymethyl)phenyl)ethanone;2-(tert-Butylamino)-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethan-1-one

Smile

OCC1=CC(C(CNC(C)(C)C)=O)=CC=C1O

InChI

InChI=1S/C13H19NO3/c1-13(2,3)14-7-12(17)9-4-5-11(16)10(6-9)8-15/h4-6,14-16H,7-8H2,1-3H3

Description

Salbutamol EP Impurity J, also designated salbutamol ketone impurity, salbutamone, and albuterol related compound B (free base), is a non-genotoxic process and degradation impurity of the phenethanolamine β2-agonist scaffold. It is structurally defined by oxidation of the secondary alcohol side chain to the corresponding ketone, retaining the aminoalcohol framework as C13H19NO3, molecular weight 237.29 g/mol, CAS 156547-62-5. In regulatory impurity profiling, its low-level measurement commonly requires LC-MS/MS with orthogonal confirmation by HPLC-UV or NMR, and in complex matrices derivatization-assisted GC-MS may be applied to resolve closely related catecholamine analogues.

References

‌Ullmann, N., Caggiano, S., & Cutrera, R. (2015). Salbutamol and around. Italian Journal of Pediatrics, 41(Suppl 2), A74. https://doi.org/10.1186/1824-7288-41-s2-a74

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