盐酸丁萘芬
Butenafine HCL
CAS: 101827-46-7
Molecular Formula: C23H27N.ClH
盐酸丁萘芬 - Names and Identifiers
| Name | Butenafine HCL |
| Synonyms | kp-363 ButenafineHCL Butenafine HCL BUTENAFINE HCL Butenafine hydrochloide BUTENAFINE HYDROCHLORIDE N-(4-t-Butylbenzyl)-N-Methyl-1-naphthalenemethylamine hydrochloride 1-(4-tert-butylphenyl)-N-methyl-N-(naphthalen-1-ylmethyl)methanamine n-(4-tert-butylbenzyl)-n-methyl-1-naphthalenemethylamine hydrochloride n-((4-(1,1-dimethylethyl)phenyl)methyl)-n-methyl-1-naphthalenemethanaminhy n-((4-(1,1-dimethylethyl)phenyl)methyl)-n-methyl-1-naphthalenemethanaminehyd |
| CAS | 101827-46-7 |
| EINECS | 642-354-4 |
| InChI | InChI=1/C23H27N.ClH/c1-23(2,3)21-14-12-18(13-15-21)16-24(4)17-20-10-7-9-19-8-5-6-11-22(19)20;/h5-15H,16-17H2,1-4H3;1H |
| InChIKey | LJBSAUIFGPSHCN-UHFFFAOYSA-N |
盐酸丁萘芬 - Physico-chemical Properties
| Molecular Formula | C23H27N.ClH |
| Molar Mass | 353.93 |
| Melting Point | 210-214°C |
| Boling Point | 426.1°C at 760 mmHg |
| Flash Point | 187.7°C |
| Solubility | DMSO 70 mg/mL (197.77 mM);Ethanol 70 mg/mL (197.77 mM);Water <1 mg/mL (<1 mM) |
| Vapor Presure | 1.82E-07mmHg at 25°C |
| Appearance | White powder |
| Color | white to off-white |
| Merck | 14,1518 |
| Storage Condition | room temp |
| MDL | MFCD00917064 |
| Physical and Chemical Properties | White Crystal or crystalline powder, odorless or slightly odorous, bitter. Soluble in methanol, ethanol or chloroform, difficult to dissolve in anhydrous acetic acid or acetonitrile, a few insoluble in ether. Melting point 200~202 °c (methanol-acetic acid). |
| Use | Allylamine antifungal agent. Has broad-spectrum antifungal activity. For fungal infections of the skin, such as body White ringworm, foot white ringworm, hip white ringworm and pityriasis versicolor. |
| In vitro study | The minimum inhibitory concentrations of Butenafine HCl for 30 representative strains of different dermatophytes ranged from 0.03-1.0 µg/mL. For two of the 10 strains of yeasts, Butenafine showed limited activity against C. albicans and no activity against M. furfur. For 25 strains representing different Gram-positive species, Butenafine HCl showed activity against β-hemolytic streptococci group A and Corynebacteria, but not against S. aureus. Butenafine was also inactive against all Gram-negative bacteria tested. Butenafine interferes with fungal ergosterol biosynthesis by inhibiting the conversion of squalene to squalene epoxide catalyzed by squalene epoxidase. Butenafine showed activity against KD-04 and KD-305 with a minimum inhibitory concentration of 12 ng/mL. |
| In vivo study | In male hartley strain guinea pigs, Butenafine (1%, once daily) showed a good therapeutic effect on dermatomycosis, and the effect was higher than that of naftifine,tolnaftate,clotrimazole, and bifonazole. Butenafine (1%), used once 24 or 48 hours before infection, showed excellent preventive efficacy against experimental Trichophyton mentagrophytes infection. After 16 weeks, 80% of the patients who used the ointment containing 2% butenafine HCl were cured, in contrast to none in the placebo group. Four patients in the active treatment group experienced subjective mild inflammation without interruption of treatment. During subsequent treatment, there were no relapses in patients who were cured, and patients in the drug-resistant and placebo groups did not improve. In the treatment of patients with positive fungal infections, Butenafine (1% cream) was used once daily for 4 weeks, resulting in an effective clinical response and cure of fungal tinea pedis. Butenafine hydrochloride (1% cream) alone is extremely effective in the treatment of patients with transitional keratinized tinea pedis. |
盐酸丁萘芬 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 21 - Harmful in contact with skin |
| WGK Germany | nwg |
| RTECS | QJ8585000 |
| HS Code | 29214990 |
盐酸丁萘芬 - Nature
Open Data Verified Data
White Crystal or crystalline powder, odorless or slightly odorous, bitter. Soluble in methanol, ethanol or chloroform, difficult to diethyl acetic acid or hexonitrile, a few flat do not dissolve in ether. The melting point was 211-213 °c.
Last Update：2024-01-02 23:10:35
盐酸丁萘芬 - Preparation Method
Open Data Verified Data
N-methyl -1-naphthylmethylamine hydrochloride and sodium carbonate were dissolved in dimethylformamide and p-tert-butylbenzyl bromide was added to react to give butenafine hydrochloride.
Last Update：2022-01-01 09:08:41
盐酸丁萘芬 - Standard
Authoritative Data Verified Data
This product is methyl-N-[4-(tert-butyl) benzyl]-1-naphthylmethylamine hydrochloride. The content of C23H27N • HCl shall not be less than 98.5% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
盐酸丁萘芬 - Trait
Authoritative Data Verified Data
- This product is a white or off-white crystalline powder; Slightly abnormal odor.
- This product is soluble in methanol or three gas methane, soluble in ethanol, slightly soluble in acetone, almost insoluble in water or ether; Almost insoluble in hydrochloric acid solution (9-10).
Last Update：2022-01-01 14:21:25
盐酸丁萘芬 - Use
Open Data Verified Data
developed by Japan Scientific Research & Pharmaceutical Co., Ltd., launched in 1992. Allylamine antifungal agent. Has broad-spectrum antifungal activity. For fungal infections of the skin, such as body White ringworm, foot white ringworm, hip white ringworm and pityriasis versicolor.
Last Update：2022-01-01 09:08:42
盐酸丁萘芬 - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add 5ml of 5% sulfuric acid solution, ultrasonic treatment, filtration, take the filtrate, add the silicotungstic acid solution Dropwise, which will produce milky white precipitate.
- 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1185).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:21:26
盐酸丁萘芬 - Exam
Authoritative Data Verified Data
- Related substances take this product, add methanol to dissolve and dilute to make about l per lml. 0 mg of the solution, as the test solution; Precision take 1ml, 100ml flask, plus mobile phase diluted to the scale, shake, as a control solution. According to the chromatographic conditions under the content determination item, 10ul of the test solution and the control solution are dissolved in a precise amount, respectively injected into the human liquid chromatograph, and the chromatogram is 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 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- weight loss on drying this product shall be dried at 105°C to constant weight, and the weight loss shall not exceed 1.0% (General rule 0831).
- l.Og of this product was taken for inspection according to law (General rule 0841). The residual residue should not exceed 0.1%.
- the residue left under the item of heavy metal extraction and ignition residue shall be inspected according to law (General Principles 0821, second law), and the content of heavy metal shall not exceed 20 parts per million.
Last Update：2022-01-01 14:21:26
盐酸丁萘芬 - Content determination
Authoritative Data Verified Data
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; With acetate buffer (sodium acetate 18g, glacial acetic acid 9.8ml, diluted with water to 1000ml)-Methanol-Isopropanol (17:70:13) as mobile phase; Detection wavelength was 282nm. Take appropriate amount of butenafine hydrochloride reference and terbinafine hydrochloride reference, add methanol to dissolve and dilute to make solutions each containing about 0.15mg per 1 ml, as the system applicable solution, take 10 u1, note human liquid chromatograph and record chromatogram. The number of theoretical plates shall not be less than 2000 based on butenafine peak. The resolution between butenafine peak and terbinafine peak shall meet the requirements.
- determination of this product, precision weighing, and methanol dissolution and quantitative dilution of about 0.15mg per lml of solution, as a test solution, the precise amount of 10 u1, injection of human liquid chromatography, record chromatogram; Another butenafine hydrochloride reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 14:21:27
盐酸丁萘芬 - Category
Authoritative Data Verified Data
antifungal drugs.
Last Update：2022-01-01 14:21:27
盐酸丁萘芬 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:21:27
盐酸丁萘芬 - Butenafine Hydrochloride Cream
Authoritative Data Verified Data
This product contains butenafine hydrochloride (C23H27N • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white.
identification
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 control solution.
examination
should comply with the relevant provisions under the term "milk aids" (chapter 0109).
Content determination
take an appropriate amount of this product (about equivalent to 15mg of butenafine hydrochloride), weigh it accurately, put it in a 100ml measuring flask, add about 70ml of methanol, and heat it in a 60°C water bath for 5 minutes, fully shake to dissolve butenafine hydrochloride, let it cool, dilute to scale with methanol, shake well, cool in an ice bath for 1 hour, remove, rapidly filter, the filtrate was taken as the test solution, and 10 u1 was accurately measured, which was obtained according to the method under the item of butenafine hydrochloride content determination.
category
Same as butenafine hydrochloride.
specification
(l ) 5g:0.05g ( 2 ) 10g:0.1g ( 3 ) 15g:0.15g (4)20g:0.2g
storage
sealed, stored in a cool place.
Last Update：2022-01-01 14:21:28
盐酸丁萘芬 - Butenafine hydrochloride spray
Authoritative Data Verified Data
This product is a multi-dose, non-quantitative topical spray. Containing butenafine hydrochloride (C23H27N • HCl) shall be 90.0% to 110.0% of the labeled amount.
trait
The content of this product is colorless to yellowish clear liquid.
identification
- 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.
- This product chloride identification (1) of the reaction (General 0301).
examination
should comply with the relevant provisions under the spray (General rule 0112).
Content determination
The precise amount of the content of this product is appropriate, and the solution containing about 0.15mg of butenafine hydrochloride per 1 ml is prepared by quantitative dilution with methanol as the test solution, according to butenafine hydrochloride content determination of the method under the item, obtained.
category
Same as butenafine hydrochloride.
specification
10ml: O.lg
storage
sealed and stored in a cool place.
Last Update：2022-01-01 14:21:29
盐酸丁萘芬 - Butenafine hydrochloride gel
Authoritative Data Verified Data
This product contains butenafine hydrochloride (C23H27N • HCI) should be 90.0% to 110.0% of the label.
trait
This product is colorless and transparent gel.
identification
- take an appropriate amount of this product and add methanol to make a solution containing about 20ug of butenafine hydrochloride per lml, filter, and measure the filtrate by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 282nm and a minimum absorption at a wavelength of 244Nm.
- 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
- According to the method under the item of content determination, start from "taking an appropriate amount of this product" to "shaking and filtering", and operate in the same method, the continuous filtrate was taken as the test solution; 1ml of the test solution was accurately measured, placed in a 100ml measuring flask, diluted with methanol to the scale, and shaken well, as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatogram is 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 sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- others shall comply with the relevant provisions under the item of gel (General rule 0114).
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; With methanol-sodium acetate solution (take sodium acetate 6.8g, add triethylamine 0.6, add water to dissolve and dilute to 1000ml, glacial acetic acid was added dropwise, and the pH value was adjusted to 4.0 (73:27). The detection wavelength was 282nm. The number of theoretical plates is not less than 2000 calculated from butenafine peak.
- determination method: take an appropriate amount of this product (about 25mg of butenafine hydrochloride), weigh it accurately, put it in a 50ml beaker, add 2.5ml of saturated sodium chloride solution, and stir to make the gel dilute, disperse, add a small amount of methanol, and transfer the solution to a 50ml measuring flask after the gel is contracted into a mass, then wash the residue 4-5 times with an appropriate amount of methanol, and incorporate the washing solution into the measuring flask, dilute to the scale with methanol, shake, filter, discard the initial filtrate, Take 5ml of the continuous filtrate precisely, put it in a 25ml measuring flask, dilute to the scale with methanol, shake well, as a test solution; In addition, an appropriate amount of butenafine hydrochloride control was accurately weighed, dissolved with methanol and quantitatively diluted to prepare a solution containing about 100ug per 1 ml as a reference solution. 20ul of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
category
Same as butenafine hydrochloride.
specification
( l)6g:0.06g (2)10g:0.lg (3)15g:0.15g
storage
seal, store in a cool place, and should prevent freezing.
Last Update：2022-01-01 14:21:30
Supplier List
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Product Name: Butenafine hydrochloride Visit Supplier Webpage Request for quotationCAS: 101827-46-7
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Mobile: 18021002903
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Multiple SpecificationsSpot supply
Product Name: Butenafine hydrochloride Visit Supplier Webpage Request for quotationCAS: 101827-46-7
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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