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PHR1286

Supelco

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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About This Item

Fórmula empírica (notación de Hill):
C15H22O3
Número de CAS:
25812-30-0
Peso molecular:
250.33
Número CE:
247-280-2
Número MDL:
MFCD00079335
Código UNSPSC:
41116107
ID de la sustancia en PubChem:
329823280
NACRES:
NA.24

grado

certified reference material
pharmaceutical secondary standard

Nivel de calidad

300

Agency

traceable to BP 363
traceable to Ph. Eur. Y0000513
traceable to USP 1288500

familia API

gemfibrozil

CofA

current certificate can be downloaded

técnicas

HPLC: suitable
gas chromatography (GC): suitable

aplicaciones

pharmaceutical (small molecule)

formato

neat

temp. de almacenamiento

2-8°C

cadena SMILES

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)

Clave InChI

HEMJJKBWTPKOJG-UHFFFAOYSA-N

Información sobre el gen

human ... PPARA(5465)

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Descripción general

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.

Aplicación

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.

Nota de análisis

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

Otras notas

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.

Nota al pie de página

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.

Pictogramas

Exclamation mark
GHS07

Palabra de señalización

Warning

Frases de peligro

H302

Clasificaciones de peligro

Acute Tox. 4 Oral

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 3

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable

Choose from one of the most recent versions:

Certificados de análisis (COA)

Lot/Batch Number
LRAD6621
LRAD4453
LRAC2789
LRAA9083
LRAA0300

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If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

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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
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
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
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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