Rosuvastatin EP Impurity A
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1714147-47-3Rosuvastatin EP Impurity A

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Catalogue No.:VL127008
CAS No.:1714147-47-3
Mol. Formula:C25H33FN3O7S•1/2Ca
Mol. Weight:558.65 g/mol

Additional information on CAS 1714147-47-3

Parent drug

Rosuvastatin

IUPAC Name

(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl[(2- hydroxy-2-methylpropyl)sulfonyl]amino]-5-pyrimidinyl]-3,5- dihydroxy-6-heptenoic acid Calcium Salt.

Pharmacopoeial Synonyms

Rosuvastatin Related Compound A

Other Synonyms

S-Desmethyl-S-(2-hydroxy-2-methylpropyl) Rosuvastatin Calcium Salt

Smile

O=C([O-])C[C@H](O)C[C@H](O)/C=C/C1=C(C(C)C)N=C(N(C)S(=O)(CC(C)(O)C)=O)N=C1C2=CC=C(F)C=C2.[Ca+2]

InChI

InChI=1S/C25H34FN3O7S.Ca/c1-15(2)22-20(11-10-18(30)12-19(31)13-21(32)33)23(16-6-8-17(26)9-7-16)28-24(27-22)29(5)37(35,36)14-25(3,4)34;/h6-11,15,18-19,30-31,34H,12-14H2,1-5H3,(H,32,33);/q;+2/p-1/b11-10+;/t18-,19-;/m1./s1 Smiles–CC(C)C1=NC(=NC(=C1/C=C/[C@H](C[C@H](CC(=O)[O-])O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)CC(C)(C)O.[Ca+2]

Description

Rosuvastatin EP Impurity A, also designated Rosuvastatin Related Compound A, CAS 1714147-47-3, is a defined process- and degradant-related impurity associated with the rosuvastatin calcium salt system. Its composition, C25H33FN3O7S•1/2Ca, corresponds to a molecular weight of 558.65 g/mol and reflects the calcium-associated hemihydrate-like stoichiometry used in pharmacopeial characterization. The structure is consistent with an oxidatively derived or synthetic route-related variant of the statin scaffold rather than a simple excipient contaminant. Trace-level determination typically requires orthogonal reversed-phase LC coupled to high-resolution MS, with LC-MS/MS for confirmation and impurity profiling under stability-indicating conditions.

References

Patil, Premchand, et al. “A NOVEL SYNTHESIS APPROACH of ROSUVASTATIN and THEIR INTERMEDIATES.” Chaudhari et Al. World Journal of Pharmaceutical Research, vol. 4, 2015, wjpr.s3.ap-south-1.amazonaws.com/article_issue/1443606533.pdf.

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