FENOFIBRATE
fenofibrate
CAS: 49562-28-9
Molecular Formula: C20H21ClO4
FENOFIBRATE - Names and Identifiers
| Name | fenofibrate |
| Synonyms | lf-178 sedufen lipantil proctofene procetofen fenofibrate isopropyl2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate isopropyl(4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid isopropyl ester 2-(4-(4-chlorobenzoyl)phenoxy)-2-methyl-propanoicaci1-methylethylester |
| CAS | 49562-28-9 |
| EINECS | 256-376-3 |
| InChI | InChI=1/C20H21ClO4/c1-13(2)24-19(23)20(3,4)25-17-11-7-15(8-12-17)18(22)14-5-9-16(21)10-6-14/h5-13H,1-4H3 |
FENOFIBRATE - Physico-chemical Properties
| Molecular Formula | C20H21ClO4 |
| Molar Mass | 360.83 |
| Density | 1.177±0.06 g/cm3(Predicted) |
| Melting Point | 80-810C |
| Boling Point | 469.8±35.0 °C(Predicted) |
| Water Solubility | 0.8mg/L(25 ºC) |
| Solubility | Soluble in acetone, ether, DMSO (15 mg/ml), DMF (30 mg/ml), ethanol (1 mg/ml), methanol |
| Appearance | powder |
| Color | off-white |
| Merck | 14,3978 |
| Storage Condition | room temp |
| MDL | MFCD00133314 |
| Physical and Chemical Properties |
|
| Use | Used as hypolipidemic drugs |
FENOFIBRATE - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| RTECS | UA2453400 |
| HS Code | 29189900 |
| Toxicity | LD50 in mice: 1600 mg/kg orally (Sornay) |
FENOFIBRATE - Reference
| Reference Show more | 1. Wei Yaqing, Lu Jiangwei, Ren Jungang, Zhang Wenjun, Wang Li, Wang Peng-Guang. Preparation and sustained release properties of fenofibrate/mesoporous silica [J]. Applied Chemical Engineering, 2020,49(07):1687-1692. 2. [IF = 4.451] Jie Gao et al."Ferulic acid targets ACSL1 to ameriorate lipid meta-disorders in db/db mice." J Funct Foods. 2022 Apr;91:105009 3. Li Feng-Jiao et al. [IF = 6.543]. "A Novel Method for Identifying Parkin Binding Agents in Complex Preparations of Herbal Medicines." Oxid Med Cell Longev. 2022;2022:3260243 |
FENOFIBRATE - Content determination
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane as filler; Water (pH adjusted to 2.5 with phosphoric acid)-acetonitrile (30:70) as mobile phase; The detection wavelength was 286nm, the theoretical plate number is not less than 3000 based on the fenofibrate peak.
assay
take about 10mg of this product, weigh it accurately, put it in a 100ml measuring flask, add an appropriate amount of mobile phase, fully shake to dissolve, dilute it to the scale with mobile phase, shake well, 10ul was accurately measured, injected into the liquid chromatograph, and the chromatogram was recorded. The fenofibrate reference substance was also measured by the same method, and the peak area was calculated according to the external standard method.
Last Update：2024-04-10 22:29:15
FENOFIBRATE - Trait
- This product is white or off-white crystalline powder; Odorless.
- This product is very soluble in chloroform, soluble in acetone or ether, slightly soluble in ethanol, almost insoluble in water.
melting point
The melting point of this product (General 0612) should be 78~82°C.
Last Update：2024-04-10 22:29:15
FENOFIBRATE - Differential diagnosis
- take this product, add anhydrous ethanol to dissolve and make a solution containing about l0ug per lml, and measure by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 286NM.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 248).
Last Update：2024-04-10 22:29:15
FENOFIBRATE - Category
hypolipidemic drugs.
Last Update：2024-04-10 22:29:15
FENOFIBRATE - Storage
light shielding, sealed storage.
Last Update：2024-04-10 22:29:15
FENOFIBRATE - Exam
clarity and color of ethanol solution
take this product l.Og, add 25ml ethanol, shake to dissolve (slightly warm if necessary), the solution should be clear and colorless; In case of color development, compare with yellow No. 1 Standard Colorimetric solution (General rule 0901 first method), not deeper.
sulfate
take this product l. Add 50ml of water, shake, heat at 50°C for 10 minutes, fully shake to dissolve, let it cool, filter, take 25ml of filtrate, and check according to law (General rule 0802), not more concentrated (0.04%) than the control solution made of standard potassium sulfate solution.
chloride
take this product l. Add 10ml of water, shake, heat at 50°C for 10 minutes, fully shake to dissolve, let it cool, add water to 20ml, filter, take 10ml of filtrate, check according to law (General rule 0801), not more concentrated (0.01%) than the control solution made from of standard sodium chloride solution.
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing about 0.4mg per lml, as a test solution; Take appropriate amount of precision children, A solution containing 0.4ug per 1 ml was prepared by dilution with the mobile phase as a control solution. According to the high performance liquid chromatography (General 0512) test, silica gel bonded with eighteen alkyl silane was used as the filler; Water (adjusted to pH 2.5 with phosphoric acid)-acetonitrile (30:70) was used as the mobile phase; the detection wavelength was 286mn. Take appropriate amounts of 4 '-chloro-4-hydroxybenzophenone (impurity I) and 2-[4-(4-chlorobenzoyl)-phenoxy]-2-methylpropionic acid (impurity II), add the mobile phase to dissolve and make the mixed solution contained in each lml, take 10ul, inject into the liquid chromatograph, and the separation degree of impurity I peak and impurity II peak shall meet the requirements; 10ul of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.1% ) , the sum of each impurity peak area shall not be greater than 5 times (0.5%) of the main peak area of the control solution. The chromatogram of the test solution is 0.1 times smaller than the main peak area of the control solution.
residual solvent
take this product about l.O g, precision weighing, put in 20ml headspace bottle, precision plus internal standard solution (N-propanol, diluted with N, N-dimethylformamide to make about 1 mg solution per 1 ml) lml and 9ml of N, N-dimethylformamide were dissolved by shaking, sealed, and used as the test solution; The appropriate amount of acetone, isopropyl alcohol, chloroform and toluene were respectively taken, and then accurately weighed, prepare mixed solution containing about 1 mg, 1 mg, 0.012mg and 0.178mg respectively in each lml by quantitative dilution with N, N-dimethylformamide. Take 5ml for precise measurement and put it in 20ml headspace bottle, precision Add 1 ml of human internal standard solution and 4ml of N, N-dimethylformamide, shake, seal, as a reference solution. Test as residual solvent assay (General 0861 second method). With 6% cyanopropylphenyl-94% dimethylpolysiloxane (or polar similar) as stationary liquid; The initial temperature is 40°C, maintain 8 minutes, at a rate of 45°C per minute to 200°C, maintain 3 minutes; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the internal standard method to calculate the peak area, the residual amount of acetone, isopropanol, chloroform and toluene should be in accordance with the provisions.
loss on drying
take this product, at 50°C under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2024-04-09 19:04:54
FENOFIBRATE - Standard
This product is isopropyl 2-methyl -2-[4-(4-chlorobenzoyl) phenoxy] propanoate. Calculated as dried product, the content of C20H21C104 shall not be less than 98.5%.
Last Update：2024-04-09 20:52:54
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