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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.

N-Desmethyl N-ethyl Rosuvastatin Sodium Salt

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Catalogue No.:	VE0026639
CAS No.:	N/A
Mol. Formula:	C23H29FN3NaO6S
Mol. Weight:	517.55 g/mol

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Additional information on

Parent drug

Rosuvastatin

IUPAC Name

sodium (E,3R,5S)-7-[2-[ethyl(methylsulfonyl)amino]-4-(4-fluorophenyl)-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

CCN(S(=O)(C)=O)C1=NC(C2=CC=C(F)C=C2)=C(/C=C/[C@@H](O)C[C@H](CC([O-])=O)O)C(C(C)C)=N1.[Na+]

InChI

InChI=1S/C23H30FN3O6S.Na/c1-5-27(34(4,32)33)23-25-21(14(2)3)19(11-10-17(28)12-18(29)13-20(30)31)22(26-23)15-6-8-16(24)9-7-15;/h6-11,14,17-18,28-29H,5,12-13H2,1-4H3,(H,30,31);/q;+1/p-1/b11-10+;/t17-,18-;/m1./s1

Description

N-Desmethyl N-ethyl Rosuvastatin Sodium Salt impurity is a process-related degradation product observed during synthesis and alkaline hydrolysis of rosuvastatin intermediates. Characterization by HPLC, LC-MS and NMR confirms demethylation and ethyl substitution at the pyrimidine ring, producing a sodium salt with distinct retention time and mass fragmentation pattern. Its presence at trace levels can affect potency and stability profiles, triggering identification and quantification under ICH Q3A/Q3B control strategies. Robust analytical methods including validated HPLC-UV and LC-MS/MS assays and targeted purification steps are recommended to monitor formation, establish qualification thresholds, and mitigate risk in upstream synthesis and formulation.