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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.

3a-Hydroxy Pravastatin-D3 Sodium Salt

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Catalogue No.:	DVE002085
CAS No.:	N/A
Mol. Formula:	C23H32D3NaO7
Mol. Weight:	449.5 g/mol

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Additional information on

Parent drug

Pravastatin

IUPAC Name

sodium (3R,5R)-7-[(1S,2R,3S,8S,8aR)-3-hydroxy-2-methyl-8-[(2S)-2-(trideuteriomethyl)butanoyl]oxy-1,2,3,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

[2H]C([2H])([2H])[C@@H](CC)C(=O)O[C@H]1CC=CC2=C[C@H]([C@@H]([C@@H]([C@@H]12)CC[C@H](C[C@H](CC(=O)[O-])O)O)C)O.[Na+]

InChI

InChI=1S/C23H36O7.Na/c1-4-13(2)23(29)30-20-7-5-6-15-10-19(26)14(3)18(22(15)20)9-8-16(24)11-17(25)12-21(27)28;/h5-6,10,13-14,16-20,22,24-26H,4,7-9,11-12H2,1-3H3,(H,27,28);/q;+1/p-1/t13-,14+,16+,17+,18-,19+,20-,22-;/m0./s1/i2D3;

Description

3a-Hydroxy Pravastatin-D3 Sodium Salt impurity represents a deuterium-labeled oxidative metabolite related to pravastatin synthesis and degradation pathways. As a polar sodium salt of the 3a-hydroxy derivative, it exhibits distinct chromatographic retention and mass spectral signature useful for trace-level identification in stability and process impurity studies. Controlled by validated HPLC and LC-MS/MS methods, specification limits and forced-degradation profiling are critical to ensure product purity. The impurity's solubility profile, hygroscopicity, and potential for interconversion under acidic or basic conditions inform synthetic route optimization and impurity control strategies. Documentation of impurity profile supports regulatory filings and quality assurance.