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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.

6,7-Dihydro O-Butyl-Rosuvastatin

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Catalogue No.:	VE0026535
CAS No.:	N/A
Mol. Formula:	C26H38FN3O6S
Mol. Weight:	539.7 g/mol

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Additional information on

Parent drug

Rosuvastatin

IUPAC Name

tert-butyl (3R,5R)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyheptanoate

Pharmacopeial Synonyms

N/A

Synonyms

(3R,5R)-t-Butyl 7-(4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyheptanoate

Smiles

CC(C)C1=NC(=NC(=C1CC[C@H](C[C@H](CC(=O)OC(C)(C)C)O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C

InChI

InChI=1S/C26H38FN3O6S/c1-16(2)23-21(13-12-19(31)14-20(32)15-22(33)36-26(3,4)5)24(17-8-10-18(27)11-9-17)29-25(28-23)30(6)37(7,34)35/h8-11,16,19-20,31-32H,12-15H2,1-7H3/t19-,20-/m1/s1

Description

6,7-Dihydro O-Butyl-Rosuvastatin is a structurally defined process-related impurity characterized as (3R,5R)-t-Butyl 7-(4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyheptanoate. The impurity contains two stereogenic centers, tert-butyl ester and O-butyl moieties and typically originates from incomplete deprotection or inadvertent O-alkylation during esterification steps. Its presence can affect API purity and stability and therefore requires rigorous characterization and control. Recommended analytical approaches include reversed phase HPLC with UV and LC-MS detection for quantitation and monitoring, complemented by 1H/13C NMR and chiral HPLC for structural confirmation. Control strategy follows ICH impurity guidance via synthetic optimization, purification and validated assays.