PHR1620

Fluvastatin sodium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): (3R,5S,6E)-rel-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid monosodium salt
• Empirical Formula (Hill Notation): C₂₄H₂₅FNNaO₄
• CAS Number: 93957-55-2
• Molecular Weight: 433.45
• MDL number: MFCD08063391
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823514
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0001082; traceable to USP 1285931
• API family: fluvastatin
• CofA: current certificate can be downloaded
• packaging: ampule of 1 × 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: [Na+].CC(C)n1c(\C=C\[C@H](O)C[C@H](O)CC([O-])=O)c(-c2ccc(F)cc2)c3ccccc13
• InChI: 1S/C24H26FNO4.Na/c1-15(2)26-21-6-4-3-5-20(21)24(16-7-9-17(25)10-8-16)22(26)12-11-18(27)13-19(28)14-23(29)30;/h3-12,15,18-19,27-28H,13-14H2,1-2H3,(H,29,30);/q;+1/p-1/b12-11+;/t18-,19-;/m0./s1
• InChI key: ZGGHKIMDNBDHJB-RPQBTBOMSA-M

Description

General description

Fluvastatin sodium is a lipid-lowering drug that belongs to the group of compounds known as statins. It acts by inhibiting the enzyme HMG-CoA reductase that plays a key role in the cholesterol production. It is generally used to reduce plasma cholesterol levels and prevent cardiovascular disease.[1]
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Fluvastatin sodium may be used as a reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.[2][3][4]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA5290 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable