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1204222-85-4Dapagliflozin Hydroxy Impurity
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| Catalogue No.: | VL1650007 |
|---|---|
| CAS No.: | 1204222-85-4 |
| Mol. Formula: | C21H25ClO7 |
| Mol. Weight: | 424.87 g/mol |
Additional information on CAS 1204222-85-4
Parent drug
DapagliflozinIUPAC Name
(1S)-1,5-anhydro-1-C-[4-chloro-3-[(E)-(4- ethoxyphenyl)(hydroxy)methyl]phenyl]-D-glucitolPharmacopoeial Synonyms
Dapagliflozin Impurity FP BOther Synonyms
(2S,3R,4S,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triolSmiles
O[C@H]1[C@H](C2=CC=C(Cl)C(C(C3=CC=C(OCC)C=C3)O)=C2)O[C@H](CO)[C@@H](O)[C@@H]1OInChI
InChI=1S/C21H25ClO7/c1-2-28-13-6-3-11(4-7-13)17(24)14-9-12(5-8-15(14)22)21-20(27)19(26)18(25)16(10-23)29-21/h3-9,16-21,23-27H,2,10H2,1H3/t16-,17?,18-,19+,20-,21+/m1/s1Description
Dapagliflozin Hydroxy Impurity also known as Dapagliflozin Impurity FP B; Hydroxy Dapagliflozin, 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 Dapagliflozin. Dapagliflozin Hydroxy Impurity is a well-characterized reference material that meets stringent regulatory standards set by USP, EMA, JP, and BP. It plays a key role in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial production of Dapagliflozin.
References
KARUMANCHI, KISHORE, et al. “Synthesis of Metabolites of Dapagliflozin: An SGLT2 Inhibitor.†Journal of Chemical Sciences, vol. 132, no. 1, Feb. 2020, https://doi.org/10.1007/s12039-020-1747-x .Bailey, Clifford J., et al. “Effect of Dapagliflozin in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control with Metformin: A Randomised, Double-Blind, Placebo-Controlled Trial.†The Lancet, vol. 375, no. 9733, June 2010, pp. 2223–33, https://doi.org/10.1016/s0140-6736(10)60407-2.Request a Quote
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