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Merck

PHR1246

Fenofibrate

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

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

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Fórmula empírica (notación de Hill):
C20H21ClO4
Número CAS:
49562-28-9
Peso molecular:
360.83
NACRES:
NA.24
PubChem Substance ID:
329823250
UNSPSC Code:
41116107
EC Number:
256-376-3
MDL number:
MFCD00133314

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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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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

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.

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.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H373

Hazard Classifications

STOT RE 2 Oral

target_organs

Liver

Clase de almacenamiento

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «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)
J Trottier et al.
Clinical pharmacology and therapeutics, 94(4), 533-543 (2013-06-13)
Glucuronidation, catalyzed by uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, detoxifies cholestatic bile acids (BAs). We aimed to (i) characterize the circulating BA-glucuronide (BA-G) pool composition in humans, (ii) determine how sex and UGT polymorphisms influence this composition, and (iii) analyze the effects
Stanley M H Chan et al.
Diabetes, 62(6), 2095-2105 (2013-01-26)
Endoplasmic reticulum (ER) stress is suggested to cause hepatic insulin resistance by increasing de novo lipogenesis (DNL) and directly interfering with insulin signaling through the activation of the c-Jun N-terminal kinase (JNK) and IκB kinase (IKK) pathway. The current study
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