Rosuvastatin (2R)-Lactone
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  • New Jersey, USA
  • Czech Republic, EU
  • Mumbai, India

* Stock subject to availability.

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.

Rosuvastatin (2R)-Lactone

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Catalogue No.:VE0026637
CAS No.:N/A
Mol. Formula:C22H26FN3O5S
Mol. Weight:463.52 g/mol

Additional information on

Parent drug

Rosuvastatin

IUPAC Name

N-[4-(4-fluorophenyl)-5-[(E)-2-[(2R)-4-hydroxy-6-oxooxan-2-yl]ethenyl]-6-propan-2-ylpyrimidin-2-yl]-N-methylmethanesulfonamide

Smiles

[H]/C(C1=C(C2=CC=C(F)C=C2)N=C(N(S(=O)(C)=O)C)N=C1C(C)C)=C([C@H]3CC(O)CC(O3)=O)/[H]

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-/m0/s1

Description

Rosuvastatin (2R)-Lactone is a cyclic lactone impurity formed via intramolecular esterification of rosuvastatin's hydroxy acid moiety under acidic or thermal conditions. As a less polar, more lipophilic degradation product it can alter assay accuracy, dissolution behavior and stability profiles, so it is routinely monitored during synthesis, formulation and stability testing. Identification and quantification are performed by reversed-phase HPLC with UV detection and confirmed by LC-MS and NMR for structural elucidation. Process and formulation controls such as pH management, solvent selection and robust impurity profiling are implemented to limit formation and ensure compliance with regulatory and pharmacopeial expectations.

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