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PHR1286

Supelco

吉非罗齐

Pharmaceutical Secondary Standard; Certified Reference Material

同義詞:

2,2-二甲基-5-(2,5-二甲基苯氧基)戊酸, 2,2-二甲基-5-(2,5-二甲苯氧基)戊酸, 5-(2,5-二甲基苯氧基)-2,2-二甲基戊酸

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About This Item

經驗公式(希爾表示法):
C15H22O3
CAS號碼:
分子量::
250.33
EC號碼:
MDL號碼:
分類程式碼代碼:
41116107
PubChem物質ID:
NACRES:
NA.24

等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

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

API 家族

gemfibrozil

CofA

current certificate can be downloaded

技術

HPLC: suitable
gas chromatography (GC): suitable

應用

pharmaceutical (small molecule)

格式

neat

儲存溫度

2-8°C

SMILES 字串

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 密鑰

HEMJJKBWTPKOJG-UHFFFAOYSA-N

基因資訊

human ... PPARA(5465)

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一般說明

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.

應用

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.

分析報告

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

其他說明

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.

腳註

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.

象形圖

Exclamation mark

訊號詞

Warning

危險聲明

危險分類

Acute Tox. 4 Oral

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析證明 (COA)

Lot/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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