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Pharmaceutical Secondary Standard; Certified Reference Material

5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic acid, 2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentanoic acid, 2,2-Dimethyl-5-(2,5-xylyloxy)valeric acid
Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


pharmaceutical (small molecule)



pharmacopeia traceability

traceable to BP 363
traceable to PhEur Y0000513
traceable to USP 1288500

storage temp.


SMILES string




InChI key


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.


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, 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.


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.


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Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

13 - Non Combustible Solids



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)
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
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
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

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