Rosuvastatin FP Impurity B

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Catalogue No.:	VE006136
CAS No.:	N/A
Mol. Formula:	C22H28FN3O6S
Mol. Weight:	481.54 g/mol

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Additional information on Rosuvastatin FP Impurity B

Parent drug

Rosuvastatin

IUPAC Name

(3R,5S)-5-[(6RS)-8-fluoro-2-(N-methylmethane-sulfonamido)-4-(propan-2-yl)-5,6-dihydro-benzo[h]quinazolin-6-yl]-3,5-dihydroxypentanoic acid

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

CC(C)C1=NC(N(C)S(C)(=O)=O)=NC2=C1C[C@]([C@](O)([H])C[C@@]([H])(O)CC(O)=O)([H])C3=C2C=CC(F)=C3

InChI

InChI=1S/C22H28FN3O6S/c1-11(2)20-17-10-16(18(28)8-13(27)9-19(29)30)15-7-12(23)5-6-14(15)21(17)25-22(24-20)26(3)33(4,31)32/h5-7,11,13,16,18,27-28H,8-10H2,1-4H3,(H,29,30)/t13-,16-,18+/m1/s1

Description

Rosuvastatin FP Impurity B standard is a well-characterized compound that aligns with key regulatory guidelines, including USP, EMA, JP, and BP. It plays a crucial role in analytical method development, method validation (AMV), and quality control (QC) processes, particularly in the manufacturing of Rosuvastatin. This impurity standard is valuable for both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA), ensuring reliable and precise analytical outcomes.