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Merck

PHR1620

Supelco

Fluvastatin Natrium

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

(3R,5S,6E)-rel-7-[3-(4-Fluorphenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptensäure Mononatriumsalz

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About This Item

Empirische Formel (Hill-System):
C24H25FNNaO4
CAS-Nummer:
Molekulargewicht:
433.45
MDL-Nummer:
UNSPSC-Code:
41116107
PubChem Substanz-ID:
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to Ph. Eur. Y0001082
traceable to USP 1285931

API-Familie

fluvastatin

Analysenzertifikat (CofA)

current certificate can be downloaded

Verpackung

ampule of 1 × 1 g

Methode(n)

HPLC: suitable
gas chromatography (GC): suitable

Anwendung(en)

pharmaceutical (small molecule)

Format

neat

Lagertemp.

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

InChIKey

ZGGHKIMDNBDHJB-RPQBTBOMSA-M

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Allgemeine Beschreibung

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.
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.

Anwendung

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.
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.

Fußnote

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.

Lagerklassenschlüssel

11 - Combustible Solids

WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


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Analysenzertifikate (COA)

Lot/Batch Number

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Fluvastatin Sodium
USP42/NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 43(5), 1972-1972 (2019)
The role of statin drugs in combating cardiovascular diseases-A review
Pichandi S, et al
International journal of current science research, 1(2), 47-56 (2011)
Development and validation of stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin, and rosuvastatin in pharmaceuticals
Gomes FP, et al.
Analytical Letters, 42(12), 1784-1804 (2009)
Determination of Fluvastatin Sodium Extended-release Tablets by HPLC
Zhang S, et al.
China Pharmacy, 42(34), 1784-1804 (2007)
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