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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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Nombre del producto

Gemfibrozil, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

HEMJJKBWTPKOJG-UHFFFAOYSA-N

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)

SMILES string

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

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

Quality Level

300

Gene Information

human ... PPARA(5465)

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

Application

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

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)
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
Ana Maria Sierra Villar et al.
International journal of pharmaceutics, 431(1-2), 161-175 (2012-04-14)
Self-nanoemulsifying drug delivery systems of gemfibrozil were developed under Quality by Design approach for improvement of dissolution and oral absorption. Preliminary screening was performed to select proper components combination. Box-Behnken experimental design was employed as statistical tool to optimize the
P A Todd et al.
Drugs, 36(3), 314-339 (1988-09-01)
Gemfibrozil is a lipid-regulating agent which is generically classified as a fibric acid derivative, but which exhibits different pharmacological effects from other such drugs. Published data indicate that in patients with all types of dyslipidaemia (except type I) gemfibrozil 800
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