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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 (3R)-Hydroxy-pyrrolidinamide (>90%)

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Catalogue No.:	VE0026439
CAS No.:	N/A
Mol. Formula:	C27H43NO7
Mol. Weight:	493.6 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-[(3R)-3-hydroxypyrrolidin-1-yl]-7-oxoheptyl]-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)N3CC[C@H](C3)O)O)O)O

InChI

InChI=1S/C27H43NO7/c1-4-16(2)27(34)35-24-13-21(31)11-18-6-5-17(3)23(26(18)24)8-7-19(29)12-22(32)14-25(33)28-10-9-20(30)15-28/h5-6,11,16-17,19-24,26,29-32H,4,7-10,12-15H2,1-3H3/t16-,17-,19+,20+,21+,22+,23-,24-,26-/m0/s1

Description

Pravastatin (3R)-Hydroxy-pyrrolidinamide (>90%) is a process related impurity encountered during pravastatin manufacture and is critical for impurity profiling and regulatory control. Characterization typically employs orthogonal techniques including HPLC with UV detection, LC-MS for mass confirmation, and NMR for stereochemical assignment and structural validation. Accurate quantification and stability assessment support qualification per ICH Q3A and Q3B thresholds and inform specification limits. Reference material at >90% purity enables method development, forced degradation studies, and batch release testing. Implementing a validated stability indicating assay and traceable documentation ensures robust quality control, risk mitigation, and compliance with current good manufacturing practice.