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PHR1620

Supelco

Fluvastatin sodium

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyma:

(3R,5S,6E)-rel-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid monosodium salt

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About This Item

Empirický vzorec (Hillův zápis):
C24H25FNNaO4
Číslo CAS:
Molekulová hmotnost:
433.45
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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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.
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.
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.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Osvědčení o analýze (COA)

Lot/Batch Number

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Development and validation of stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin, and rosuvastatin in pharmaceuticals
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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)
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)
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