在庫拠点

New Jersey, USA
Czech Republic, EU
Mumbai, India

* 在庫状況によります

Documentation

MSDSをダウンロード

サンプルCOAをダウンロード

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。

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

● 在庫あり

カタログ番号:	VE0026439
CAS番号:	N/A
分子式:	C27H43NO7
分子量:	493.6 g/mol

見積もり依頼

RFQリストに追加

に関する追加情報

親薬物

Pravastatin

IUPAC名

[(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

同義語

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

説明

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.