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PHR1620

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Fluvastatin sodium

Pharmaceutical Secondary Standard; Certified Reference Material

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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

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

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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.

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
Masao Nishiya et al.
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