Salbutamol EP Impurity M (Formate Salt)
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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Salbutamol EP Impurity M (Formate Salt)

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Catalogue No.:VL1880007
CAS No.:N/A
Mol. Formula:C14H23NO3.CH2O2
Mol. Weight:299.37 g/mol

Additional information on Salbutamol EP Impurity M (Formate Salt)

Parent drug

Salbutamol

IUPAC Name

(1RS)-2-[(1,1-Dimethylethyl)amino]-1-[4-hydroxy-3(methoxymethyl)phenyl]ethanol formate salt

Pharmacopeial Synonyms

Salbutamol BP Impurity M(Formate Salt); Levalbuterol Related Compound C(Formate Salt)

Other Synonyms

N/A

Smiles

COCC1=CC([C@](O)([H])CNC(C)(C)C)=CC=C1O.OC=O

InChI

InChI=1S/C14H23NO3.CH2O2/c1-14(2,3)15-8-13(17)10-5-6-12(16)11(7-10)9-18-4;2-1-3/h5-7,13,15-17H,8-9H2,1-4H3;1H,(H,2,3)/t13-;/m0./s1

Description

Salbutamol EP Impurity M (Formate Salt), also known as Salbutamol BP Impurity M(Formate Salt); Levalbuterol Related Compound C(Formate Salt), in various pharmacopoeias, is a highly characterized standard. It meets strict regulatory requirements set by USP, EMA, JP, and BP, making it a crucial component in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial production of Salbutamol. Salbutamol EP Impurity M is an impurity of Salbutamol. It is a short-acting drug and a moderately selective beta(2)-receptor agonist is widely used as a bronchodilator that helps to to manage asthma.

References

Lavorini, Federico, et al. Clinical and Functional Responses to Salbutamol Inhaled via Different Devices in Asthmatic Patients with Induced Bronchoconstriction.” British Journal of Clinical Pharmacology, vol. 58, no. 5, Nov. 2004, pp. 512–20, https://doi.org/10.1111/j.1365-2125.2004.02185.x.

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