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Key Documents

PHR1246

Supelco

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:
Molecular Weight:
360.83
EC Number:
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. 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)

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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 USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

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.

Footnote

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.

Recommended products

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.

Pictograms

Health hazard

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

STOT RE 2 Oral

Target Organs

Liver

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Certificates of Analysis (COA)

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