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内容: HPLC、MASS/LC-MS、1H NMR、FT-IR、含量、構造解析レポート（SER）、および製品に応じた追加分析データ。

3a-Hydroxy Pravastatin-D3 Sodium Salt

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カタログ番号:	DVE002085
CAS番号:	N/A
分子式:	C23H32D3NaO7
分子量:	449.5 g/mol

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に関する追加情報

親薬物

Pravastatin

IUPAC名

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

同義語

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;

説明

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.