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Merck

PHR1286

ゲムフィブロジル

Pharmaceutical Secondary Standard; Certified Reference Material

別名:

2,2-ジメチル-5-(2,5-ジメチルフェノキシ)ペンタン酸

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この商品について

実験式（ヒル表記法）:
C15H22O3
CAS番号:
25812-30-0
分子量:
250.33
NACRES:
NA.24
PubChem Substance ID:
329823280
UNSPSC Code:
41116107
EC Number:
247-280-2
MDL number:
MFCD00079335

主要文書

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製品名

ゲムフィブロジル, 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

このような2次標準は、USP、EP（PhEur）、BPの1次標準にマルチトレーサビリティを提供します。

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

保管分類

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

適用法令

試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。

PHR1286-1G: + PHR1286-1G-PW:

jan

試験成績書（COA）

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以前この製品を購入いただいたことがある場合

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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)
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
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
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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