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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 D9 Ammonium Salt

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Catalogue No.:	DVE002063
CAS No.:	N/A
Mol. Formula:	C23H26D9O7.NH4
Mol. Weight:	450.61 g/mol

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Additional information on

Parent drug

Pravastatin

IUPAC Name

Ammonium (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-{[(2S)-2-(D3)methyl(D6)butanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

C[C@H]1C=CC2=C[C@@H](O)C[C@H](OC(C([2H])(C([2H])([2H])[2H])C([2H])([2H])C([2H])([2H])[2H])=O)[C@]2([H])[C@H]1CC[C@@H](O)C[C@@H](O)CC([O-])=O.[H][N+]([H])([H])[H]

InChI

InChI=1S/C23H36O7.H3N/c1-4-13(2)23(29)30-20-11-17(25)9-15-6-5-14(3)19(22(15)20)8-7-16(24)10-18(26)12-21(27)28;/h5-6,9,13-14,16-20,22,24-26H,4,7-8,10-12H2,1-3H3,(H,27,28);1H3/t13?,14-,16+,17+,18+,19-,20-,22-;/m0./s1/i1D3,2D3,4D2,13D;

Description

Pravastatin D9 Ammonium Salt is a deuterated impurity observed in pravastatin active pharmaceutical ingredient batches, relevant for impurity profiling and stability studies. The impurity exhibits a mass shift consistent with nine deuterium incorporations and is typically characterized by LC-MS, NMR and high resolution mass spectrometry to confirm isotopic labeling and chemical structure. Monitoring of Pravastatin D9 Ammonium Salt supports method validation, forced degradation studies and quantitative HPLC assays to ensure product purity and regulatory compliance. Control strategies include specification limits, reference standard qualification and stability indicating method development to detect trace level presence during synthesis and downstream processing.