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PHR1246

Fenofibrate

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

Key Documents

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Product Name

Fenofibrate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

YMTINGFKWWXKFG-UHFFFAOYSA-N

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

SMILES string

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

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

Quality Level

300

Gene Information

human ... PPARA(5465)

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Analysis Note

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

Application

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

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.

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.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H373

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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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)
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)
Wei He et al.
International journal of pharmaceutics, 445(1-2), 69-78 (2013-02-12)
A novel biocompatible shell-crosslinked nanocapsule system was developed based on nanoemulsion templates stabilized by a class of food proteins. The nanoemulsion templates were prepared using a combination of mechanical mixing and high-pressure homogenization, while the nanocapsule shell formed simultaneously through
Cordula Stillhart et al.
The Journal of pharmacy and pharmacology, 65(2), 181-192 (2013-01-03)
To advance in vitro screening of surfactant/co-solvent formulations in early development by considering drug supersaturation and the mechanism of solubilization upon aqueous dilution. Two surfactant/co-solvent model systems were studied at practically relevant aqueous dilution ratios. Precipitation of the model drug
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