Clotrimazole ZnSO4 complex
clotrimazole crystalline
CAS: 23593-75-1
Molecular Formula: C22H17ClN2
Clotrimazole ZnSO4 complex - Names and Identifiers
| Name | clotrimazole crystalline |
| Synonyms | myclo Clotrimazole (Chlorotrityl)imidazole clotrimazole crystalline Clotrimazole ZnSO4 complex 1-(o-Chloro-α,α-diphenylbenzyl)imidazole (2-Chlorophenyl)diphenyl-1-imidazolylmethane 1-(alpha-(2-Chlorophenyl)benzhydryl)imidazole 1[(2-chlorophenyl)diphenylmethyl]-1H-imidazole 1-((2-chlorophenyl)diphenylmethyl)-1h-imidazol 1-[(2-chlorophenyl)diphenylmethyl]-1h-imidazol 1-(o-chloro-alpha,alpha-diphenylbenzyl)-imidazol |
| CAS | 23593-75-1 |
| EINECS | 245-764-8 |
| InChI | InChI=1/C22H17ClN2/c23-21-14-8-7-13-20(21)22(25-16-15-24-17-25,18-9-3-1-4-10-18)19-11-5-2-6-12-19/h1-17H |
| InChIKey | VNFPBHJOKIVQEB-UHFFFAOYSA-N |
Clotrimazole ZnSO4 complex - Physico-chemical Properties
| Molecular Formula | C22H17ClN2 |
| Molar Mass | 344.84 |
| Density | 1.1095 (rough estimate) |
| Melting Point | 147-149°C |
| Boling Point | 501.14°C (rough estimate) |
| Flash Point | 245.5°C |
| Water Solubility | <10mg/L(25 ºC) |
| Solubility | Soluble in DMSO (25 mM), chloroform (50 mg/ml), DMF, ethyl acetate, ethanol, methanol |
| Vapor Presure | 5.42E-09mmHg at 25°C |
| Appearance | Crystallization |
| Color | White to Almost white |
| Maximum wavelength(λmax) | ['556nm(Phosphate buffer sol.)(lit.)'] |
| Merck | 14,2417 |
| pKa | pKa 4.7(EtOH 50%aq ) (Uncertain) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.5940 (estimate) |
| MDL | MFCD00057220 |
| Physical and Chemical Properties | White powder or colorless crystalline powder. Melting point 147-149 °c. Soluble in ethanol, acetone, chloroform, almost insoluble in water. Odorless, tasteless, quickly decomposed in acid solution. Clotrimazole hydrochloride, melting point 159 °c. |
| Use | Antimycotic drugs for the treatment of epidermal and deep fungal infections |
Clotrimazole ZnSO4 complex - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed R36/38 - Irritating to eyes and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | NI4377000 |
| HS Code | 29332900 |
| Toxicity | LD50 in male mice, rats (mg/kg): 923, 708 orally (Tettenborn) |
Clotrimazole ZnSO4 complex - Upstream Downstream Industry
| Raw Materials | Benzene Acetone Toluene 2-Chlorobenzoyl chloride 2-Chlorotrichlorotoluene Thionyl chloride Imidazole Aluminum chloride Petroleum benzin |
Clotrimazole ZnSO4 complex - Reference
| Reference Show more | 1. Chen Shun, Cui Lili, Gao Shouhong, Lu Wenquan, Song Jiangli, Wang Zhipeng. Investigation on Extraction Methods and Content Determination of Effective Components from Oral Ulcer Film [J]. Journal of Pharmaceutical Practice, 2020,38(05):466-468 480. |
Clotrimazole ZnSO4 complex - Standard
Authoritative Data Verified Data
This product is l-[(2-chlorophenyl) benzhydryl]-1H-imidazole. Calculated as dried product, the content of C22H17C1N2 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
Clotrimazole ZnSO4 complex - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Odorless.
- This product is soluble in methanol or chloroform, soluble in ethanol or acetone, almost insoluble in water.
melting point
The melting point of this product (General 0612) is 141~145°C.
Last Update：2022-01-01 11:55:53
Clotrimazole ZnSO4 complex - Introduction
Clotrimazole is a synthetic antifungal drug and a broad-spectrum derivative of imidazole
Last Update：2022-10-16 17:15:09
Clotrimazole ZnSO4 complex - Differential diagnosis
Authoritative Data Verified Data
- take about 10 mg of this product, add 1 ml of sulfuric acid to dissolve, and show orange yellow; Add 3ml of water to dilute, and the color disappears; Add 3ml of sulfuric acid to reappear orange yellow.
- take an appropriate amount of this product, add methylene chloride to dissolve and dilute to prepare a solution containing about 5mg per 1 ml as a test solution; the clotrimazole control was dissolved in dichloromethane and diluted to prepare a solution containing about 5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, 10 u1 of the test solution and 10 u1 of the reference solution were taken, respectively, on the same silica gel G thin layer plate, with isopropyl ether as the developing solvent. A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder for saturation, deployment, air drying, and color development in iodine vapor, the position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1270).
Last Update：2022-01-01 11:55:54
Clotrimazole ZnSO4 complex - Exam
Authoritative Data Verified Data
imidazole
take this product, add chloroform to make a solution containing about lOOmg per lml, as a test solution; Take another imidazole reference, add three gas methane to make a solution containing about 0.50mg per lml, as a control solution. According to the thin layer chromatography (General 0502) test, absorb 5ul of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with xylene-n-propyl-concentrated ammonia solution (180:20:1) is a developer, which is developed, dried, and colored in iodine vapor. If the test solution shows impurity spots corresponding to the control solution, the color of the test solution should not be deeper (0.5%) than the main spot of the control solution.
Related substances
take this product, precision weighing, plus 70% methanol to dissolve and quantitatively dilute to make a solution containing about 0.2mg per lml, as a test solution; precisely take 1 ml of the test solution, put it in a 100ml measuring flask, dilute it to the scale with 70% methanol, shake it well, and use it as a control solution; Take diphenyl-(2-chlorophenyl) methanol (impurity I) control appropriate amount, precision weighing, quantitative dilution with 70% methanol to make a solution containing about 1 ug per 1 ml, as a control solution. The appropriate amounts of clotrimazole control, impurity I control and imidazole control were diluted with 70% methanol to prepare solutions containing 0.04mg, 0.03mg and 0.05mg, respectively, per 1 ml, as system applicable solutions. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler; Methanol -0.05mol/L potassium dihydrogen phosphate solution (7:3)(Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 215nm. Take 10ul of the applicable solution of the system, inject the liquid chromatograph, record the chromatogram. The theoretical plate number is not less than 4000 calculated by the clotrimazole peak, and the separation degree between the clotrimazole peak and the impurity I peak should be greater than 2.0. 20 ml of each of the test solution, the control solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 2.5 times of the retention time of the main component peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and the content of impurity I shall not exceed 0.3%, outside the impurity I peak, the sum of the peak areas of other impurities shall not be greater than 0.25 times (0.25%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall 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 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 11:55:55
Clotrimazole ZnSO4 complex - Content determination
Authoritative Data Verified Data
take this product 0.3g, precision weighing, add glacial acetic acid 20ml dissolved, add crystal violet indicator liquid 1 drop, with perchloric acid titration solution (0.1 mol/L) titration to the solution is blue-green, and the result of the titration is corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 34.48mg of C22H17C1N2.
Last Update：2022-01-01 11:55:55
Clotrimazole ZnSO4 complex - Category
Authoritative Data Verified Data
antifungal drugs.
Last Update：2022-01-01 11:55:55
Clotrimazole ZnSO4 complex - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:55:56
Clotrimazole ZnSO4 complex - Clotrimazole oral film
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a white sheet film.
identification
- take an appropriate amount of this product (approximately equivalent to clotrimazole 20mg), plus O. 10ml of 1 mol/L sulfuric acid solution was stirred to dissolve clotrimazole, filtered, and several drops of trinitrophenol test solution were added to the filtrate to produce yellow precipitate.
- take an appropriate amount of this product (about 20mg of clotrimazole), add 4ml of dichloromethane, shake to dissolve clotrimazole, centrifuge, and take the supernatant as the test solution, A solution containing about 5mg per 1 ml was prepared by dissolving and diluting with dichloromethane as a control solution. Test by thin layer chromatography (General 0502), draw 10 u1 of test solution and 10 u1 of reference solution respectively, and put them on the same silica gel G thin layer plate with isopropyl ether as developing solvent, A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder for saturation, deployment, air drying, and color development in iodine vapor, the position and color of the main spot displayed by the test solution should be the same as that of the reference 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.
- two items (2) and (3) above can be selected as one item.
examination
- diphenyl-(2-chlorophenyl) fermentation liquid take an appropriate amount of this product (equivalent to 10mg of clotrimazole), Precision weighing, put it in a 50ml measuring flask, add methanol 28ml, ultrasound, dissolve clotrimazole by shaking constantly, add 12ml of water, shake well, cool, dilute to scale with methanol-water (7:3), shake well, filter, take the continued filtrate as the test solution; Take the appropriate amount of impurity I reference, precision weighing, add methanol-water (7:3) A solution containing about 2ug per 1 ml was prepared as a control solution by dissolution and quantitative dilution. According to the chromatographic conditions under the content determination item, 10 u1 of the test solution and the reference solution are accurately measured and injected into the liquid chromatograph respectively, and the chromatograms are recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount shall not be exceeded. The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- melting time take this product, cut into 6 pieces of film with the size of lcm2 respectively, and clamp them with two layers of stainless steel wire with the inner diameter of 2.0mm, according to the method under the disintegration time inspection method tablets (General 0921) inspection, should be completely dissolved within 15 minutes, and through the sieve.
- others shall comply with the relevant provisions under the film (General 0125).
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 -0.05mol/L potassium dihydrogen phosphate solution (70:30)(Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 215nm. Take the appropriate amount of the reference substance and the reference substance of impurity I, add methanol-water (7:3) to dissolve and dilute to prepare solutions containing 0.04mg and 0.03mg respectively per 1 ml, take 10 u1 for precision measurement and inject human Liquid Chromatograph. The number of theoretical plates shall not be less than 4000 based on clotrimazole peak, and the separation degree between clotrimazole peak and impurity I peak shall be greater than 2.0.
- determination of 10 tablets of this product, cut and crushed, each 100ml measuring flask, add methanol 56ml, ultrasonic, and constantly shake to dissolve clotrimazole, add water 24ml, shake, cool, dilute to the scale with methanol-water (7:3), shake well, filter, take the filtrate as a test solution, take 10 u1 with precision, inject into liquid chromatograph, record chromatogram; additionally, an appropriate amount of clotrimazole reference substance was weighed accurately, dissolved and quantitatively diluted with methanol-water (7:3) to prepare a solution containing about 0.04mg per 1 ml, which was determined by the same method. The content of each tablet was calculated by peak area according to external standard method, and the average content of 10 tablets was obtained.
category
Same as clotrimazole.
specification
4mg
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:55:56
Clotrimazole ZnSO4 complex - Clotrimazole Vaginal Tablets
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) should be the label amount of 95.0% ~ 105.0%.
trait
This product is white or off-white.
identification
- take an appropriate amount of the fine powder of this product (about 20mg of clotrimazole), add 4ml of dichloromethane, shake, dissolve clotrimazole, centrifuge, take the supernatant as the test solution; Take the clotrimazole control, A solution containing about 5mg per 1 ml was prepared by dissolving and diluting with dichloromethane as a control solution. According to the thin layer chromatography (General 0502) test, draw 10ul of the test solution and the reference solution, and put them on the same silica gel G thin layer plate with isopropyl ether as the developing solvent, A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder for saturation, deployment, removal, air drying, and color development in iodine vapor, the position and color of the main spot displayed by the test solution should be the same as that of the reference 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.
- two items (1) and (2) above can be selected as one item.
examination
- acidity: take an appropriate amount of fine powder of this product (about equivalent to clotrimazole l.Og ), add 20ml of water, fully shake, and measure it according to law (General rule 0631). The pH value should be 3.0~4.5.
- diphenyl-(2-chlorophenyl) Methanol the appropriate amount of fine powder under the content determination item (about 10mg of clotrimazole) was accurately weighed and placed in a 50ml measuring flask, add 70% methanol to dissolve and dilute to the scale, shake well, filter, and take the filtrate as the test solution; Take the appropriate amount of impurity I control by precision weighing, 70% methanol was added to dissolve and quantitatively dilute to prepare a solution containing about 2% per 1 ml, and the solution was shaken to be used as a control solution. According to the chromatographic conditions under the content determination item, take 10ul of the test solution and the reference solution, respectively inject into the liquid chromatograph, record the chromatogram, if there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount shall not be exceeded.
- 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 -0.05mol/L potassium dihydrogen phosphate solution (70:30)(10% phosphoric acid to adjust the pH value to 5.7~5.8) as mobile phase; The detection wavelength was 215nm. Take an appropriate amount of clotrimazole and impurity I reference substance, add methanol to dissolve and dilute to prepare solutions containing 0.04mg and 0.03mg respectively in each lml, and inject 10u1 into the liquid chromatograph, the number of theoretical plates is calculated according to the clotrimazole peak not less than 4000, and the degree of separation between the clotrimazole peak and the impurity I peak should be greater than 2.0.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to clotrimazole 80mg), put in a 100ml measuring flask, dissolve clotrimazole by shaking with 60ml of 70% methanol, dilute to the scale with 70% methanol, shake well, filter, Take 5ml of continued filtrate and put it in a measuring flask, dilute to the scale with 70% methanol, shake well, filter through the filter, take the filtrate as the test solution, take a precise amount of LOL into the human liquid chromatograph, record the chromatogram; Take an appropriate amount of clotrimazole reference, precision weighing, plus 70% methanol dissolved and quantitatively diluted into each 1 ml containing about 0.04mg of the solution, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as clotrimazole.
specification
(1)0.lg (2)0.15g (3)0.25g (4)0.5g
storage
protected from light, sealed, and stored in a dry place.
Last Update：2022-01-01 11:55:57
Clotrimazole ZnSO4 complex - Clotrimazole cream
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) should be the label amount of 90.0% ~ 110.0%.
trait
This product is white cream.
identification
- take an appropriate amount of this product (about 20mg equivalent to clotrimazole), add 0.5mol/L sulfuric acid solution 10ml, slightly warm in a water bath, stir to dissolve clotrimazole, cool, filter, A few drops of trinitrophenol test solution were added to the filtrate to produce a light yellow precipitate.
- take an appropriate amount of this product (about 20mg of clotrimazole), add 4ml of methylene chloride, shake to dissolve clotrimazole, cool, centrifuge, and take the supernatant as the test solution; the clotrimazole control was dissolved in dichloromethane and diluted to prepare a solution containing about 5mg per 1 ml as a control solution. Test by thin layer chromatography (General 0502), draw 10 u1 of test solution and 10 u1 of reference solution respectively, and put them on the same silica gel G thin layer plate with isopropyl ether as developing solvent, A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder for saturation, deployment, air drying, and color development in iodine vapor, the position and color of the main spot displayed by the test solution should be the same as that of the reference 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.
- two items (2) and (3) above can be selected as one item.
examination
- diphenyl-(2-azophenyl) Methanol take an appropriate amount of this product (equivalent to 10 mg of clotrimazole), weigh it accurately, put it in a 50ml measuring flask, add 28ml of methanol, place it in 50C water bath for 5 minutes, shake it constantly, shake it vigorously for 5 minutes after taking it out, add 12ml of water, shake it well, let it cool, dilute it to the scale with 70% methanol, shake it well, place it in an ice bath for 2 hours, filter through the filter, take the filtrate and then put it at room temperature for use as a test solution; Take an appropriate amount of reference substance for impurity I and weigh it precisely, A solution containing about 2ug per 1 ml was prepared by dissolving and quantitatively diluting with 70% methanol as a control solution. According to the chromatographic conditions under the content determination item, 10 u1 of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount shall not be exceeded.
- others should comply with the relevant provisions under the cream (General rule 0109).
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 -0.05mol/L potassium dihydrogen phosphate solution (70:30)(Adjust pH to 10% ~ 5.7 with 5.8 phosphoric acid) as mobile phase; The detection wavelength is 215nm, add 70% methanol to dissolve and dilute to make solutions containing 0.04mg and 0.03mg respectively in each lml, take L01 for precise measurement, and inject human Liquid Chromatograph. The number of theoretical plates shall not be less than 4000 based on clotrimazole peak, the degree of separation between the peak of clotrimazole and the peak of impurity I should be greater than 2.0.
- determination Method: Mix 5 pieces of contents of this product, weigh an appropriate amount (about 4mg of clotrimazole) accurately, put them in a 100ml measuring flask, add 56ml of methanol, and heat them in a 50°C water bath for 5 minutes, shake constantly, take out and shake strongly for 5 minutes, add water 24ml, shake, cool, dilute to scale with 70% methanol, shake well, cool in ice bath for 2 hours, filter through filter, the filtrate was taken to room temperature as a test solution, and the sample was accurately measured by 10 ml, injected into the liquid chromatograph, and the chromatogram was recorded, 70% methanol was added to dissolve and quantitatively diluted to prepare a solution containing about mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as clotrimazole.
specification
(1)1% (2)3%
storage
sealed, stored in the cool dark.
Last Update：2022-01-01 11:55:58
Clotrimazole ZnSO4 complex - Clotrimazole Pellicles
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a white sheet film.
identification
- take an appropriate amount of this product (approximately equivalent to clotrimazole 20mg), plus 0.10ml of 1 mol/L sulfuric acid solution was stirred to dissolve clotrimazole, filtered, and several drops of trinitrophenol test solution were added to the filtrate to produce yellow precipitate.
- take an appropriate amount of clotrimazole (equivalent to 20mg clotrimazole), add 4ml of methylene chloride, shake to dissolve clotrimazole, let it cool, filter, and take the filtrate as a test solution; the clotrimazole control was dissolved in dichloromethane and diluted to prepare a solution containing about 5mg per 1 ml as a control solution. Test by thin layer chromatography (General 0502), draw 10 u1 of test solution and 10 u1 of reference solution respectively, and put them on the same silica gel G thin layer plate with isopropyl ether as developing solvent, A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder for saturation, deployment, drying, and coloring in iodine vapor, the position and color of the main spot displayed by the test solution should be the same as that of the reference 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. The above (2), (3) two items can be done one.
examination
- diphenyl-(2-gas phenyl) Methanol take an appropriate amount of this product (equivalent to clotrimazole lOmg), precise weighing, put it in a 50ml measuring flask, add 70% methanol 30ml, place it in a 60°C water bath and heat it for 10 minutes, shake it constantly, shake it vigorously for 5 minutes after taking it out, let it cool, dilute it with 70% methanol to the scale, shake it well, filter it through a filter membrane, the continued filtrate was taken as the test solution; An appropriate amount of the reference substance of impurity I was also taken, precisely weighed, dissolved and quantitatively diluted with 70% methanol to prepare a solution containing about 2ug in 1 ml, which was used as the reference solution. According to the chromatographic conditions under the content determination item, l0ul of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I peak, the peak area shall be calculated according to the external standard method, and the amount of 1,0% of the labeled amount shall not be exceeded.
- melting time take this product, respectively, cut into 6 pieces of lcm2 size film, respectively, with two layers of mesh diameter 2.0mm stainless steel wire clamp, according to the disintegration time inspection method under the tablet method (General 0921) inspection, should be completely dissolved within 15 minutes, and pass through the sieve.
- others shall comply with the relevant provisions under the film (General 0125).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler; Methanol -0.05 mol/L potassium dihydrogen phosphate solution (70:30)(Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 215nm. Take an appropriate amount of clotrimazole reference substance and impurity I reference substance, add 70% methanol to dissolve and dilute to prepare solutions containing 0.04mg and 0.03mg respectively per lml, and inject 10ul into human liquid chromatograph, the number of theoretical plates is calculated according to the clotrimazole peak not less than 4000, and the degree of separation between the clotrimazole peak and the impurity I peak should be greater than 2.0.
- determination of 20 tablets of this product, precision weighing, cut, precision weighing an appropriate amount (equivalent to clotrimazole 80mg), put in a 100ml measuring flask, add 70% methanol 60ml, place it in a 60°C water bath and heat it for 10 minutes, shake it constantly, shake it vigorously for 5 minutes after taking it out, let it cool, dilute it with 70% methanol to the scale, shake it well, filter it, take 5ml of continued filtrate accurately, put it in a 70% measuring flask, dilute it to the scale with methanol, shake it well, filter it through the filter, take the continued filtrate as the test solution, and take 10 u1 accurately, note human liquid chromatograph and record the chromatogram. Take an appropriate amount of clotrimazole reference substance, weigh it precisely, dissolve it with 70% methanol and dilute it quantitatively to make a solution containing about 0.04mg per lml. According to the external standard method to calculate the peak area, that is.
category
Same as clotrimazole.
specification
50mg
storage
sealed and stored in a cool and dry place.
Last Update：2022-01-01 11:55:59
Clotrimazole ZnSO4 complex - Clotrimazole Suppositories
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) should be the label amount of 90.0% ~ 110.0%.
trait
This product is milky white to yellowish suppository.
identification
- Take 2 capsules of this product, add 10ml of petroleum ether, warm on a water bath to dissolve the Matrix. After cooling, pour off the petroleum ether, and wash the residue twice with a small amount of petroleum ether, the petroleum ether heated to the residue on the water bath was evaporated; The residue was taken according to the identification (2) test under the item of clotrimazole, showing the same results.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- diphenyl-(2-azophenyl) toluene take an appropriate amount of this product (equivalent to 20mg of clotrimazole), precise weighing, put it in a 100ml measuring flask, add 56ml of methanol, place it in a 50°C water bath and heat it, then shake it to dissolve it. Take it out and shake it strongly for 5 minutes, add 24ml of water, shake it well, let it cool, dilute it to the scale with 70% methanol, and shake it well, filter the filter, take the filtrate as the test solution; Take the impurity I control, precision weighing, plus 70% methanol dissolved and quantitatively diluted to prepare 2ug solution per lml, as a control solution. According to the chromatographic conditions under the content determination item, 10ul of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount shall not be exceeded.
- others should comply with the relevant provisions under suppository (General rule 0107).
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 -0.05mol/L potassium dihydrogen phosphate solution (70:30)(Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 215nm. Take an appropriate amount of clotrimazole reference substance and impurity I reference substance, add 70% methanol to dissolve and dilute to prepare a solution containing 0.04mg and 0.03mg respectively in each lml, and inject Louli into human liquid chromatograph, the number of theoretical plates is calculated according to the clotrimazole peak not less than 4000, and the degree of separation between the clotrimazole peak and the impurity I peak should be greater than 2.0.
- determination Method: Take 10 capsules of this product, weigh them precisely, put them in an evaporation dish, heat them on a water bath until they melt, and stir them constantly to make them well mixed and cool, take an appropriate amount (about 40mg of clotrimazole), put it in a 100ml measuring flask, add an appropriate amount of methanol, heat it in a 50°C water bath, shake it to dissolve it, then take it out and shake it strongly for 5 minutes, cool, dilute to the scale with methanol, shake well, filter, take 10ml of continuous filtrate accurately, put it in a 100ml measuring flask, dilute to the scale with 70% methanol, shake well, filter through membrane, the continuous filtrate was taken as the test solution, and 10 u1 was accurately measured. The liquid chromatograph was injected and the chromatogram was recorded, add 70% methanol to dissolve and quantitatively dilute to prepare a solution containing about mg per 1 ml, which is determined by the same method and calculated by peak area according to external standard method.
category
Same as clotrimazole.
specification
0.15g
storage
sealed and stored at 30°C or less.
Last Update：2022-01-01 11:56:00
Clotrimazole ZnSO4 complex - Clotrimazole spray
Authoritative Data Verified Data
This product is a non-quantitative topical spray. The clotrimazole (C22H37CIN2) content shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is a colorless to yellowish clear liquid.
identification
- take an appropriate amount of clotrimazole, dry on a water bath, dissolve and dilute the residue with chloroform to prepare a solution containing 2mg clotrimazole per 1 ml; Take an appropriate amount of clotrimazole reference, A solution containing 2mg per 1 ml was prepared by dissolving and diluting with chloroform. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel G thin layer plate, with isopropyl ether as the developing solvent, A small beaker filled with concentrated ammonia solution was placed in the expansion cylinder to be saturated, expanded, taken out, dried, and colored in iodine vapor. The position and color of the main spot displayed by the test solution is the same as that 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 Control Solution &
- two items (1) and (2) above can be selected as one item.
examination
- diphenyl-(2-chlorophenyl) Methanol take 2ml of this product, put it in a 70% measuring flask, dilute it to the scale with methanol, shake it well, and use it as a test solution; separately, the reference product of impurity I was precision weighed, dissolved and diluted with 70% methanol to prepare a solution containing 3ug per 1 ml as a reference solution. According to the chromatographic conditions under the content determination item, l0ul of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount shall not be exceeded.
- others should comply with the relevant provisions under the spray (General rule 0112).
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 -0.05mol/L potassium dihydrogen phosphate solution (70:30)(Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 215nm. Take an appropriate amount of clotrimazole and impurity I reference substance, add 70% methanol to dissolve and dilute to prepare solutions containing 0.04mg and 0.03mg respectively in each lml, and inject 10u1 into human liquid chromatograph, the number of theoretical plates is calculated according to the clotrimazole peak not less than 4000, and the degree of separation between the clotrimazole peak and the impurity I peak should be greater than 2.0.
- measuring method: take 2ml of this product for precision measurement, put it in a 100ml measuring flask, dilute it to the scale with 70% methanol, shake it well, take 5ml for precision measurement, put it in a 50ml measuring flask, dilute with 70% methanol to the scale, shake, as a test solution, take the l0ul precision, inject human liquid chromatograph, record the chromatogram; Take the appropriate amount of clotrimazole reference, precision weighing, add 70% methanol to dissolve and dilute to prepare a solution containing about mg per 1 ml, which is determined by the same method and calculated by peak area according to external standard method.
category
Same as clotrimazole.
specification
1.5%
storage
sealed and stored in a cool place.
Last Update：2022-01-01 11:56:01
Clotrimazole ZnSO4 complex - Clotrimazole solution
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) should be the label amount of 90.0% ~ 110.0%.
trait
This product is a colorless to yellowish clear liquid.
identification
- take an appropriate amount of this product, put it on a water bath and evaporate it to dryness. Add three gas methane to the residue to make a solution containing Clotrimazole 2mg per 1 ml, A solution containing 2mg per 1 ml was prepared by dissolving and diluting with three gases of methane. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel G thin layer plate, with isopropyl ether as the developing solvent, A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder for saturation, deployment, air drying, and color development in iodine vapor, the position and color of the main spot displayed by the test solution is the same as that 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.
- two items (1) and (2) above can be selected as one item.
examination
- diphenyl-(2-chlorophenyl) toluene take 2ml of this product, put it in a 100ml measuring flask, dilute it to the mark with 70% methanol, shake it well, filter it through a filter membrane, the continued filtrate was taken as the test solution; And the reference substance of impurity I was precision weighed, dissolved and quantitatively diluted with 70% methanol to prepare a solution containing about 4.5ug per 1 ml as the reference solution. According to the chromatographic conditions under the content determination item, each lol of the test solution and the reference solution is accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 1.5% of the labeled amount shall not be exceeded.
- others shall be in accordance with the relevant provisions under the item of paint (General rule 0118).
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 -0.05mol/L potassium dihydrogen phosphate solution (70:30)(Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as a mobile phase; The detection wavelength was 215mn. Take an appropriate amount of clotrimazole reference substance and impurity I reference substance, add 70% methanol to dissolve and dilute to prepare a solution containing 0.04mg and 0.03mg respectively in each lml, and inject Louli into human liquid chromatograph, the number of theoretical plates is calculated according to the clotrimazole peak not less than 4000, and the degree of separation between the clotrimazole peak and the impurity I peak should be greater than 2.0.
- measurement precision: take 1ml of the product, put it in a 100ml measuring flask, dilute it to the scale with 70% methanol, shake it well, filter it through the filter, take 5ml of the filtrate and put it in a 25ml measuring flask, dilute with 70% methanol to the scale, shake, as a test solution, take 10 u1, inject into the liquid chromatograph, record the chromatogram; Take an appropriate amount of clotrimazole reference, precision weigh, add 70% methanol to dissolve and quantitatively dilute to prepare a solution containing about mg per 1ml, which is determined by the same method and calculated by peak area according to external standard method.
category
Same as clotrimazole.
specification
1.5%
storage
sealed storage.
Last Update：2022-01-01 11:56:02
Clotrimazole ZnSO4 complex - Clotrimazole And Betamethasone Dipropionate Cream
Authoritative Data Verified Data
This product contains clotrimazole (C22H17C1N2) and betamethasone dipropionate in betamethasone (C22H29F05) calculation, should be 90.0% ~ 110.0% of the label amount.
prescription
clotrimazole log
Betamethasone dipropionate 0.643g (equivalent to betamethasone 0.5g)
Appropriate amount of matrix
Made up to 1000g
trait
This product is white cream.
identification
In the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks in the control solution.
examination
- diphenyl-(2-chlorophenyl) Methanol take an appropriate amount of this product (equivalent to 10 mg of clotrimazole), precise weighing, put it in a 50ml measuring flask, add 28ml of methanol, place it in a 50°C water bath and heat it, then shake it to dissolve it. Then take it out and shake it strongly for 5 minutes, add 12ml of water, shake it well, let it cool, dilute it to the scale with 70% methanol, and shake it well, filter the filter, take the filtrate as the test solution; Take the clotrimazole impurity I control, precision weighing, plus 70% methanol dissolved and quantitatively diluted to make 4ug solution per lml, as a control solution. In addition to the detection wavelength of 215nm, according to the chromatographic conditions under the content determination item, accurately take each L01 of the reference solution and the test solution, respectively inject into the liquid chromatograph, record the chromatogram, if there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of clotrimazole impurity I peak, the peak area shall be calculated according to the external standard method, and 2.0% of the labeled amount of clotrimazole shall not be exceeded.
- others should comply with the relevant provisions under the cream (General rule 0109).
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 0.05mol/L potassium dihydrogen phosphate solution (70:30)(PH adjusted to 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 240nm. The theoretical plate number is not less than 4000 calculated by clotrimazole peak, and the separation degree between clotrimazole peak, betamethasone dipropionate peak, clotrimazole impurity I Peak and other impurity peaks shall meet the requirements.
- determination: take an appropriate amount of this product (about equal to 10 mg of clotrimazole), put it in a 50ml measuring flask, add an appropriate amount of 70% methanol, place it in a 50°C water bath and heat it, and shake it constantly to dissolve the two main components, then take out a strong shake for 5 minutes, shake, cool, dilute with 70% methanol to the scale, shake, ice bath for 2 hours, filter, take the continuous filtrate placed at room temperature as the test solution, take 50 u1 in a precise amount, inject it into the liquid chromatograph, and record the chromatogram, 70% methanol was added to dissolve and quantitatively prepare a solution containing Clotrimazole 0.2mg and betamethasone dipropionate 10ug per 1 ml, which was determined by the same method and calculated by peak area according to external standard method.
category
antifungal drugs.
specification
5G: clotrimazole 50mg with betamethasone dipropionate 3.215mg (2.5mg based on betamethasone)
storage
sealed and stored at 25°C or lower.
Last Update：2022-01-01 11:56:03
Clotrimazole ZnSO4 complex - Compound clotrimazole cream
Authoritative Data Verified Data
This product contains clotrimazole (C22H17CIN2) and urea (CH4N20) should be 90.0% to 110.0% of the label amount.
prescription
clotrimazole 15.0g
Urea 150g
Appropriate amount of matrix
Made up to 1000g
trait
This product is a white to yellowish milk tone.
identification
- take an appropriate amount of this product (about 20mg equivalent to clotrimazole), add 0.5mol/L sulfuric acid solution 10ml, slightly warm in a water bath, stir to dissolve clotrimazole, cool, filter, take 2ml of the filtrate and add several drops of trinitrophenol test solution to form a yellow precipitate.
- 1ml of the above filtrate was taken, and 1ml of sulfuric acid was slowly added dropwise, and the solution was vibrated continuously to show orange yellow color. After dilution with 3ml of water, the color disappeared.
- take an appropriate amount of this product (about 0.2g of urea), put it in a test tube for heating, that is, it decomposes and releases ammonia gas; When it meets the moist red litmus paper, it can turn blue.
- take an appropriate amount of this product (about 20mg of clotrimazole), add 4ml of dichloromethane, shake for 30 minutes, centrifuge, take the supernatant as the test solution; Take the clotrimazole control, A solution containing 5mg per 1 ml was prepared by dissolving and diluting with dichloromethane as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate, with isopropyl ether as the developing solvent, A small beaker filled with concentrated ammonia solution is placed in the deployment cylinder to saturate the ammonia vapor, expand, dry, and display color in the iodine vapor, the position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot of the reference 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.
- two items (4) and (5) above can be selected as one item.
examination
- diphenyl-(2-chlorophenyl)-fermented yeast take an appropriate amount of this product (about equivalent to clotrimazole lOmg), Precision weighing, put it in a 50ml measuring flask, add methanol 28ml, place it in a 50°C water bath and heat it for 5 minutes, shake it constantly, shake it vigorously for 5 minutes after taking it out, add 12ml of water, shake it well, let it cool, and use methanol-water (7:3). Dilute to the scale, shake well, place in an ice bath for 2 hours, filter through the filter, take the filtrate and put it at room temperature for use as a test solution; Take an appropriate amount of clotrimazole impurity I control, precision weighing, plus methanol-water (7:3) dissolved and quantitative dilution to make a solution containing about 2ug per 1 ml, as a reference solution. According to the chromatographic conditions under the content determination item, take 10ul of each of the reference solution and the test solution, respectively inject the human liquid chromatograph, record the chromatogram, if there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of clotrimazole impurity I peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount of clotrimazole shall not be exceeded.
- others should comply with the relevant provisions under the cream (General rule 0109).
Content determination
- clotrimazole was measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler I methanol -0.05mol/L potassium dihydrogen phosphate solution (70:30) (Adjusted to pH 10% -5.7 with 5.8 phosphoric acid) as mobile phase; Detection wavelength was 215nm. Take an appropriate amount of clotrimazole reference substance and clotrimazole impurity I reference substance, add methanol water (7:3) to dissolve and dilute to prepare solutions containing 0.04mg and 0.03mg respectively per 1 ml, take 10 u1, injection of human liquid chromatograph, the number of theoretical plate according to clotrimazole peak calculation is not less than 4000, clotrimazole peak and clotrimazole impurity I peak separation degree should be greater than 2.0.
- determination Method: Mix 5 pieces of contents of this product, weigh an appropriate amount (about 2mg of clotrimazole) accurately, put them in a 50ml measuring flask, add 28ml of methanol, and heat them in a 50°C water bath for 5 minutes, shake constantly, take out and shake strongly for 5 minutes, add 12ml of water, shake well, cool, dilute to scale with methanol-water (7:3), shake well, cool in an ice bath for 2 hours, filter through the filter, take the continuous filtrate placed at room temperature as the test solution, take 10ul for precise measurement, inject human liquid chromatograph, record the chromatogram; additionally, an appropriate amount of clotrimazole reference substance was carefully weighed, dissolved and quantitatively diluted with methanol-water (7:3) to prepare a solution containing about 40ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
- preparation of urea reference solution an appropriate amount of the urea reference was accurately weighed, dissolved with ethanol and quantitatively diluted to a solution containing about 0.5mg of urea per 1 ml.
- preparation of Test Solution take an appropriate amount of this product, precisely weigh it (about 50mg of urea), put it in a 100ml measuring flask, add 50ml of ethanol, and heat it in a hot water bath to dissolve the urea, cool, dilute to the scale with ethanol, shake well, cool in an ice bath for 30 minutes, filter through the filter, and then take the filtrate to room temperature.
- precision measurement: 3ml of the test solution and 3ml of the reference solution were respectively placed in a 25ml measuring flask, and then p-dimethylaminobenzaldehyde solution (2g of p-dimethylaminobenzaldehyde) was added to each precision, add 96ml of ethanol and 4ml of hydrochloric acid to dissolve, then obtain) 10ml, dilute to the scale with ethanol, shake well, place in the dark for 15 minutes, filter if necessary, immediately according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of NM, and the calculation was obtained.
category
antifungal drugs.
storage
It was sealed and kept in a cool and dark place.
Last Update：2022-01-01 13:43:21
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Product Name: Clotrimazole Visit Supplier Webpage Request for quotationCAS: 23593-75-1
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Product Name: clotrimazole crystalline Request for quotation
CAS: 23593-75-1
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 23593-75-1
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Clotrimazole Visit Supplier Webpage Request for quotationCAS: 23593-75-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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Raw Materials for Clotrimazole ZnSO4 complex