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PHR1246

Fenofibrate

Name: Fenofibrate
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

FEN, 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid isopropyl ester

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About This Item

Empirical Formula (Hill Notation):

C₂₀H₂₁ClO₄

CAS Number:

49562-28-9

Molecular Weight:

360.83

NACRES:

NA.24

PubChem Substance ID:

329823250

UNSPSC Code:

41116107

EC Number:

256-376-3

MDL number:

MFCD00133314

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Properties

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. F0048000, traceable to USP 1269447

API family

fenofibrate

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CC(C)OC(=O)C(C)(C)Oc1ccc(cc1)C(=O)c2ccc(Cl)cc2

InChI

1S/C20H21ClO4/c1-13(2)24-19(23)20(3,4)25-17-11-7-15(8-12-17)18(22)14-5-9-16(21)10-6-14/h5-13H,1-4H3

InChI key

YMTINGFKWWXKFG-UHFFFAOYSA-N

Gene Information

human ... PPARA(5465)

Description

General description

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.
Fenofibrate is a third-generation fibric acid derivative which is widely employed for the treatment of atherogenic dyslipidemia, hypertriglyceridemia, mixed dyslipidemia and hypercholesterolemia.

Application

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.

Fenofibrate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography and spectrophotometry techniques.

Analysis Note

These secondary standards offer multi-traceability to the US and EP primary standards, where they are available.

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

To see an example of a Certificate of Analysis for this material enter LRAC0257 in the slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

GHS08

signalword

Warning

hcodes

H373

pcodes

P260 - P314 - P501

Hazard Classifications

STOT RE 2 Oral

target_organs

Liver

Storage Class

11 - Combustible Solids

wgk

WGK 1

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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Electrochemical studies and square-wave voltammetric determination of fenofibrate in pharmaceutical formulations

Yardimci C and Ozaltin N

Analytical and Bioanalytical Chemistry, 378(2), 495-498 (2004)

Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Bulk and in Tablet Dosage Form by UV-Spectrophotometry and RP-HPLC

Karunakaran A, et al.

Stamford Journal of Pharmaceutical Sciences, 4(1), 58-63 (2011)

Estimation of Atorvastatin Calcium and Fenofibrate in Tablets by Derivative Spectrophotometry and Liquid Chromatography

Nakarani NV, et al.

Journal of AOAC (Association of Official Analytical Chemists) International, 90(3), 700-705 (2007)

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