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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.

Pravastatin Thiazolidinamide

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Catalogue No.:	VE0026482
CAS No.:	N/A
Mol. Formula:	C26H41NO6S
Mol. Weight:	495.7 g/mol

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Additional information on

Parent drug

Pravastatin

IUPAC Name

[(1S,3S,7S,8S,8aR)-8-[(3R,5R)-3,5-dihydroxy-7-oxo-7-(1,3-thiazolidin-3-yl)heptyl]-3-hydroxy-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2S)-2-methylbutanoate

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)N3CCSC3)O)O)O

InChI

InChI=1S/C26H41NO6S/c1-4-16(2)26(32)33-23-13-20(29)11-18-6-5-17(3)22(25(18)23)8-7-19(28)12-21(30)14-24(31)27-9-10-34-15-27/h5-6,11,16-17,19-23,25,28-30H,4,7-10,12-15H2,1-3H3/t16-,17-,19+,20+,21+,22-,23-,25-/m0/s1

Description

Pravastatin Thiazolidinamide is an oxidative degradation impurity encountered during pravastatin API synthesis and stability studies; the impurity’s thiazolidine-linked amide functionality imparts increased polarity and a distinct retention time versus the parent compound under reversed-phase HPLC. It is monitored with stability-indicating HPLC-UV methods and structurally confirmed by LC-MS and MS/MS fragmentation patterns. Risk mitigation relies on selection of process pH, temperature control, targeted purification and validated cleaning to limit formation. Identification and quantitation align with ICH Q3A and Q3B guidance, with specification limits established from toxicological assessment and routine surveillance to protect product purity and regulatory compliance.