BENZBROMARONE
benzbromarone
CAS: 3562-84-3
Molecular Formula: C17H12Br2O3
BENZBROMARONE - Names and Identifiers
| Name | benzbromarone |
| Synonyms | benzbromarone BENZBROMARONE LABOTEST-BB LT00134669 BENZBROMARONE, MM(CRM STANDARD) BENZBROMARONE, REFERENCE SPECTRUM EP STANDARD 3-[3,5-DIBROMO-4-HYDROXYBENZOYL]-2-ETHYLBENZOFURAN (3,5-Dibromo-4-hydroxyphenyl)(2-ethylbenzofuran-3-yl)ketone 3,5-dibromo-4-hydroxyphenyl-2-ethylbenzo[b]furan-3-yl ketone (3,5-Dibromo-4-hydroxyphenyl)(2-ethyl-1-benzofuran-3-yl)methanone |
| CAS | 3562-84-3 |
| EINECS | 222-630-7 |
| InChI | InChI=1/C17H12Br2O3/c1-2-13-15(10-5-3-4-6-14(10)22-13)16(20)9-7-11(18)17(21)12(19)8-9/h3-8,21H,2H2,1H3 |
| InChIKey | WHQCHUCQKNIQEC-UHFFFAOYSA-N |
BENZBROMARONE - Physico-chemical Properties
| Molecular Formula | C17H12Br2O3 |
| Molar Mass | 424.08 |
| Density | 1.6211 (rough estimate) |
| Melting Point | 151° |
| Boling Point | 514.1±50.0 °C(Predicted) |
| Solubility | Easily soluble in dimethylformamide, soluble in chloroform or acetone, soluble in ether, slightly soluble in ethanol, and almost insoluble in water |
| Appearance | White to off-white crystalline powder |
| Color | White to Light yellow |
| Merck | 14,1065 |
| pKa | 4.66±0.25(Predicted) |
| Storage Condition | Inert atmosphere,2-8°C |
| Refractive Index | 1.6010 (estimate) |
| MDL | MFCD00078962 |
| Physical and Chemical Properties | White to yellowish crystalline powder; Odorless, tasteless. In dimethylformamide is very soluble in chloroform or acetone, soluble in ether, slightly soluble in ethanol, almost insoluble in water. The melting point was 149-153 °c. Figure 1 is benzbromarone |
| Use | For the treatment of gout, hyperuricemia |
BENZBROMARONE - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 22 - Harmful if swallowed |
| Safety Description | 36 - Wear suitable protective clothing. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | OB1804200 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 oral in rat: 248mg/kg |
BENZBROMARONE - Standard
Authoritative Data Verified Data
This product is (3, 5-dibromo-4-ylphenyl)-(2-ethyl-3-benzobalanyl) methanone. Calculated as dry product, containing not less than 98.5% of C17H12Br203.
Last Update：2024-01-02 23:10:35
BENZBROMARONE - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Odorless.
- This product is very soluble in dimethylformamide, soluble in three gas methane or acetone, soluble in ether, slightly soluble in ethanol, almost insoluble in water.
melting point
The melting point of this product (General rule 0612 first method) is 149~153°C.
Last Update：2022-01-01 13:34:15
BENZBROMARONE - Differential diagnosis
Authoritative Data Verified Data
- take this product, add phosphate buffer solution (pH 7.6) dissolved and diluted to make a solution containing 10ug per lml, according to UV-visible spectrophotometry (puncture 0401) determination, there is a maximum absorption at a wavelength of 357nm, a minimum absorption at a wavelength of 289nm, and a shoulder at a wavelength of 240nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1094).
- take 0.lg of this product, place it in a crucible, add anhydrous sodium carbonate lg, flash at 700°C for 1 hour, let it cool, add 50ml of water, heat and dissolve, and neutralize with dilute nitric acid, identification of bromides in solution (General 0301).
Last Update：2022-01-01 13:34:16
BENZBROMARONE - Exam
Authoritative Data Verified Data
pH
take 0.50g of this product, Add 10ml of water, shake for 1 min, filter, take 2.0ml of filtrate, add methyl red indicator solution 0.lml and hydrochloric acid titration solution (0.01mol/L)0.1, the solution should be red; And sodium hydroxide titration solution (0.01mol/L)0.3, the solution should be yellow.
clarity and color of chloroform solution
take l.Og of this product and add 10ml of trichloromethane to dissolve. The solution should be clear and colorless. In case of color development, it shall not be deeper in comparison with the yellow No. 3 Standard Colorimetric solution (General rules 0901 first method).
soluble halide
take this product 0.30g, add acetone 35ml to dissolve, check according to law (General rule 0801), compared with the standard sodium chloride solution 5.0ml made of the control solution, not more concentrated (0.017%).
Related substances
take about 50mg of this product, add methanol 15ml, ultrasonic 20 minutes to dissolve, cool, dilute with mobile phase to prepare 2.5mg solution per 1 ml as the test solution; A suitable amount of 2.5UG solution per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the high performance liquid chromatography (General 0512) test, using eighteen alkyl silane bonded silica gel as filler, methanol-acetonitrile-water-glacial acetic acid (990:25:300:5) as mobile phase, the detection wavelength was 231nm. The number of theoretical plates shall not be less than 2000 based on the calculation of benzbromo Maron peak. The separation degree between benzbromo Maron peak and adjacent impurity peaks shall meet the requirements. Take 20 u1 of each of the control solution and the test solution respectively, inject the human liquid chromatograph, record the chromatogram to 2.5 times of the retention time of the main component peak, if there are impurity peaks in the chromatogram of the test solution, the peak area of impurity I (relative retention time is 0.5~0.6) shall not be greater than 4 times (0.4%) of the main peak area of the control solution, the Peak area of impurity II (relative retention time is 2.0~2.5) shall not be greater than 5 times (0.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.1% ) , the sum of the peak areas of other impurities shall not be greater than 2 times (0.2%) of the main peak area of the control solution. The chromatogram of the test solution is 0.2 times smaller than the main peak area of the control solution.
loss on drying
take this product, with phosphorus pentoxide as desiccant, 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%.
Iron Salt take ignition residue
add 0.5ml of nitric acid to the residue left under the item, and evaporate to dryness until the nitrogen oxide vapor is removed, let it cool, add 2ml of hydrochloric acid, dry it on a water bath, and add 4ml of dilute hydrochloric acid, after dissolving with slight heat, add 50mg of ammonium persulfate, add water to make 0807, and check according to law (General rule 0.002%). Compared with the control solution made of standard iron solution, it should not be deeper ().
Heavy metals
take this product 0821G, inspection according to law (General rule second law), containing heavy metals shall not exceed 10 parts per million.
arsenic salt
take 2.0g of this product, place it in the crucible, add 10ml of magnesium nitrate ethanol solution (1-50), light the ethanol, slowly cauterize the charring, let it cool, wet it with a small amount of nitric acid, and evaporate it to dryness, after the nitrogen oxide vapor is removed, it is burned to complete ash at 600 ° C. And allowed to cool, then hydrochloric acid (0822) and water () are added to dissolve, which shall be checked according to law (General Principles, Law 1), (0.0001%),
Last Update：2022-01-01 13:34:17
BENZBROMARONE - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add methanol 60ml dissolved, add water 10ml, according to the potential titration method (General rule 0701), with sodium hydroxide titration solution (0.1 mol/ L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 42.41mg of Cl7H12Blr2O3.
Last Update：2022-01-01 13:34:17
BENZBROMARONE - Category
Authoritative Data Verified Data
anti-gout drugs.
Last Update：2022-01-01 13:34:18
BENZBROMARONE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:34:18
BENZBROMARONE - Narcaricin Mite (Benzbromarone Tablets)
Authoritative Data Verified Data
This product contains benzbromarone (C17H12Br203) should be 93.0% to 107.0% of the label.
trait
This product is white or off-white.
identification
- take an appropriate amount of fine powder of this product (about 20mg equivalent to benzbromarone), add 4ml of trichloromethane for ultrasound for 5 minutes, centrifuge, and take the supernatant as the test solution, chloroform was added to dissolve and prepare a solution containing 5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively, on the same silica gel GF254 thin layer plate, with chloroform-acetone-methanol-formic acid (100:0.5:0.5:0.5) for the development of the agent, after spreading, dry, set the UV light (254nm) under the inspection, the position and color of the main spot displayed by the test solution should be consistent with the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- relevant substances: take an appropriate amount of fine powder of this product (about 50mg of benzbromarone), add 15ml of methanol, sonicate for 20 minutes to dissolve, and let it cool, dilute with mobile phase to make a solution containing 2.5mg of benzbromarone per 1 ml, filter, and take the continued filtrate as the test solution; Take appropriate amount with precision, A 2.5UG solution containing benzbromarone per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. The determination was carried out according to the method for benzbromarone related substances. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity I shall not be greater than 4 times (0.4%) of the main peak area of the control solution, the Peak area of impurity II shall not be greater than 5 times (0.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.1% ), the sum of the peak areas of other impurities 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 0.2 times smaller than the main peak area of the control solution.
- the dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with phosphate buffer solution (disodium hydrogen phosphate 12.5g, potassium dihydrogen phosphate 2.5g and sodium dodecyl sulfate g, add water to dissolve and dilute to 1000ml, with 2mol/L sodium hydroxide solution or dilute phosphoric acid to adjust the pH value to 7.5)1000ml as the dissolution medium, the rotation speed is 100 rpm, operate according to law, after 45 minutes, take an appropriate amount of the solution, filter, take a precise amount of the filtrate, put it in a 25ml measuring flask, dilute it with the dissolution medium to the scale, shake well, according to UV-Vis spectrophotometry (General 0401), the absorbance was measured at the wavelength of 356nm; Another reference substance of benzbromarone was precision weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 10ug per lml, which was determined by the same method, the dissolution amount of each tablet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-acetonitrile-water-glacial acetic acid (990:25:300:5) as mobile phase, the detection wavelength was 231nm. The number of theoretical plates shall not be less than 2000 based on the calculation of phenyl bromide Malon peak. The degree of separation between the benzbromo Maron peak and the adjacent impurity peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to benzbromarone 50tng), put in a 100ml measuring flask, add methanol 15ml, ultrasonic for 20 minutes to dissolve benzbromarone, let it cool, dilute to scale with mobile phase, shake well, filter, Take 5ml of continued filtrate precisely, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, take 20u1 injection liquid chromatograph for precise measurement, record chromatogram; Take additional benzbromarone reference substance 50mg, precise weighing, put it in 100ml measuring flask, add methanol 15ml, ultrasonic dissolution, cool, with the mobile phase diluted to scale, shake, precision take 5ml, 50ml flask, with the mobile phase diluted to scale, shake, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as benzbromarone.
specification
50mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:34:19
BENZBROMARONE - Benzbromarone capsules
Authoritative Data Verified Data
This product contains benzbromarone (C37H12Br203) should be 93.0% to 107.0% of the label.
trait
The content of this product is white or white powder.
identification
- take an appropriate amount of the content of this product (about 20mg equivalent to benzbromarone), add chloroform 4ml, sonicate for 5 minutes, centrifuge, take the supernatant as the test solution; Take the benzbromarone reference, chloroform was added to dissolve and prepare a solution containing 5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions each 5 u1, respectively point on the same silica gel GF2S4 thin layer plate, with chloroform-acetone-methanol-formic acid (100:0.5:0.5:0.5) for the development of the agent, after spreading, dry, set the UV light (254nm) under the inspection, the position and color of the main spot displayed by the test solution should be consistent with the main spot of the control solution.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- relevant substances: take an appropriate amount of the contents of this product (about 50mg of benzbromarone), add 15ml of methanol, sonicate for 20 minutes to dissolve benzbromarone, and let it cool, dilute with mobile phase to make a solution containing 2.5mg of benzbromarone per 1 ml, filter, and take the continued filtrate as the test solution; Take appropriate amount with precision, A solution containing 2.5ug of benzbromarone per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. The determination was carried out according to the method for benzbromarone related substances. If there are impurity peaks in the chromatogram of the test solution, the area of impurity T peak shall not be more than 4 times (0.4%) of the area of the main peak of the control solution; the Peak area of impurity II shall not be greater than 5 times (0.5%) of the main peak area of the control solution; The peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.1%), the sum of the peak areas of other impurities 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 0.2 times smaller than the main peak area of the control solution.
- the dissolution of this product, according to the dissolution and release moment method (General rule 0931 The first method), with phosphate buffer solution (take disodium hydrogen phosphate 12.5g, potassium dihydrogen phosphate 2.5g and sodium dodecyl sulfate g, add water to dissolve and dilute to 1000ml, with 2mol/L sodium hydroxide solution or dilute phosphoric acid to adjust the pH value to 7.5) 1000ml as the dissolution medium, the rotation speed is 100 rpm, operate according to law, after 45 minutes, take an appropriate amount of the solution, filter, take a precise amount of the filtrate, put it in a 25ml measuring flask, dilute it with the dissolution medium to the scale, shake well, according to UV-Vis spectrophotometry (General 0401), the absorbance was measured at the wavelength of 356mn; Another reference substance of benzbromarone was precision weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 10ug per lml, which was determined by the same method, the amount of dissolution of each pellet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-acetonitrile-water-glacial acetic acid (990:25:300:5) as mobile phase, the detection wavelength was 231nm. The number of theoretical plates shall not be less than 2000 based on the calculation of phenyl bromide Malon peak. The degree of separation between the benzbromo Maron peak and the adjacent impurity peak shall meet the requirements.
- the contents under the item of loading children's deviation were measured, mixed evenly and ground finely, and the appropriate amount (equivalent to 50mg) of benumbromarone was accurately weighed and placed in a 100ml measuring flask, add 15ml of methanol, sonicate for 20 minutes to dissolve benzbromarone, cool, dilute to the scale with mobile phase, shake well, filter, take 5ml of filtrate and put it in 50ml measuring flask, dilute to the scale with mobile phase, shake well, as a test solution, take 20u1 injection of human liquid chromatography with precise volume, record chromatogram; Take additional benzbromarone reference substance 50mg, precise weighing, put it in a 100ml children's bottle, add 15ml of methanol, dissolve it by ultrasound, let it cool, dilute it to scale with mobile phase, shake well, take 5ml with precision and put it in a 50ml measuring flask, diluted with mobile phase to the scale, shake, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as benzbromarone.
specification
50mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:34:20
Supplier List
Multiple SpecificationsSpot supply
Product Name: Benzbromarone Visit Supplier Webpage Request for quotationCAS: 3562-84-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Multiple SpecificationsSpot supply
Product Name: Benzbromarone Visit Supplier Webpage Request for quotationCAS: 3562-84-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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