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Merck

PHR1286

Gemfibrozil

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentanoic acid, 2,2-Dimethyl-5-(2,5-xylyloxy)valeric acid, 5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic acid

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Fórmula empírica (notación de Hill):
C15H22O3
Número CAS:
25812-30-0
Peso molecular:
250.33
NACRES:
NA.24
PubChem Substance ID:
329823280
UNSPSC Code:
41116107
EC Number:
247-280-2
MDL number:
MFCD00079335

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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000513, traceable to USP 1288500

API family

gemfibrozil

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

Cc1ccc(C)c(OCCCC(C)(C)C(O)=O)c1

InChI

1S/C15H22O3/c1-11-6-7-12(2)13(10-11)18-9-5-8-15(3,4)14(16)17/h6-7,10H,5,8-9H2,1-4H3,(H,16,17)

InChI key

HEMJJKBWTPKOJG-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.
Gemfibrozil is a cholesterol-lowering drug that effectively lowers the serum cholesterol, triglyceride, and low-density lipoprotein (LDL) levels. It also efficiently raises the serum high-density lipoprotein (HDL) levels. It is known to minimize the incidence of coronary heart diseases in humans.

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.
Gemfibrozil may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by high performance liquid chromatography (HPLC).

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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.
To see an example of a Certificate of Analysis for this material enter LRAA0300 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Clase de almacenamiento

11 - Combustible Solids

wgk

WGK 3

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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Development and validation of liquid chromatographic method for gemfibrozil and simvastatin in binary combination
Ashfaq M, et al.
Journal of the Chilean Chemical Society, 53(3), 1617-1619 (2008)
Amir Qaseem et al.
Annals of internal medicine, 159(12), 835-847 (2013-10-23)
The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the screening, monitoring, and treatment of adults with stage 1 to 3 chronic kidney disease. This guideline is based on a systematic
Sarah Y Skolness et al.
Environmental toxicology and chemistry, 31(11), 2615-2624 (2012-08-23)
Fibrates are a class of pharmaceuticals that indirectly modulate cholesterol biosynthesis through effects on peroxisome proliferator-activated receptors. Gemfibrozil is a fibrate that has been detected in wastewater treatment plant influents, effluents, and drinking water. The objective of the present study
A M Filppula et al.
Clinical pharmacology and therapeutics, 94(3), 383-393 (2013-05-10)
Cytochrome P450 (CYP) 3A4 is considered the most important enzyme in imatinib biotransformation. In a randomized, crossover study, 10 healthy subjects were administered gemfibrozil 600 mg or placebo twice daily for 6 days, and imatinib 200 mg on day 3, to study
Manthena V S Varma et al.
Pharmaceutical research, 29(10), 2860-2873 (2012-05-29)
To develop physiologically based pharmacokinetic (PBPK) model to predict the pharmacokinetics and drug-drug interactions (DDI) of pravastatin, using the in vitro transport parameters. In vitro hepatic sinusoidal active uptake, passive diffusion and canalicular efflux intrinsic clearance values were determined using
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