Rosuvastatin EP Impurity D
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503610-43-3Rosuvastatin EP Impurity D

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Catalogue No.:VL127002
CAS No.:503610-43-3
Mol. Formula:C22H26FN3O5S
Mol. Weight:463.52 g/mol

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50 mg $417.50
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Additional information on CAS 503610-43-3

Parent drug

Rosuvastatin

IUPAC Name

N-[4-(4-fluorophenyl)-5-[(1E)-2-[(2S,4R)-4-hydroxy-6-oxooxan-2-yl]ethen-1-yl]-6-(propan-2-yl)pyrimidin-2-yl]-N-methylmethanesulfonamide

Pharmacopoeial Synonyms

Rosuvastatin Lactone

Other Synonyms

Rosuvastatin (3R,5S)-Lactone; Rosuvastatin (5S)-Lactone ; (N-[4-(4-Fluorophenyl)-5-{(E)-2-[(2S,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]vinyl}-6-isopropylpyrimidin-2-yl]-N-methylmethanesulfonamide)

Smiles

FC1=CC=C(C2=C(C(C(C)C)=NC(N(S(C)(=O)=O)C)=N2)/C=C/[C@H](C[C@H](C3)O)OC3=O)C=C1

InChI

InChI=1S/C22H26FN3O5S/c1-13(2)20-18(10-9-17-11-16(27)12-19(28)31-17)21(14-5-7-15(23)8-6-14)25-22(24-20)26(3)32(4,29)30/h5-10,13,16-17,27H,11-12H2,1-4H3/b10-9+/t16-,17-/m1/s1

Description

Rosuvastatin EP Impurity D, also designated Rosuvastatin (3R,5S)-Lactone or Rosuvastatin (5S)-Lactone, CAS 503610-43-3, is a closed-ring lactone degradant of the statin scaffold formed by intramolecular esterification of the hydroxy acid side chain. This impurity reflects pH and temperature dependent back-lactonization during synthesis, storage, or forced degradation. With molecular formula C22H26FN3O5S and molecular weight 463.52 g/mol, it is structurally close to the parent drug and may require orthogonal characterization by LC-MS/MS, HPLC with diode array detection, and, where stereochemical resolution is needed, chiral LC or NMR. Its presence is typically evaluated under pharmacopoeial impurity control frameworks.

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