TiapridHCl - Names and Identifiers
Name | Tiapride HCl
|
Synonyms | Cuckool TiapridHCl Tiapride HCl Tiapridhydrochlorid Tiapride hydrochloride N-(2-(Diethylamino)ethyl)-5-(methylsulfonyl)-o-anisamide hydrochloride N-[2-(DIETHYLAMINO)ETHYL]-5-[METHYL-SULFONYL]-O-ANISAMIDE HYDROCHLORIDE n-(2-(diethylamino)ethyl)-2-methoxy-5-(methylsulfonyl)-benzamidmonohydroch n-(2-(diethylamino)ethyl)-2-methoxy-5-(methylsulfonyl)benzamidehydrochloride N-(2-(Diethylamino)ethyl)-2-methoxy-5-(methylsulfonyl)benzamide hydrochloride n-(2-(diethylamino)ethyl)-2-methoxy-5-(methylsulfonyl)-benzamidmonohydrochloride N-[2-(diethylamino)ethyl]-2-methoxy-5-(methylsulphonyl)benzamide monohydrochloride N-(2-(Diethylamino)ethyl)-2-methoxy-5-(methylsulphonyl)benzamide monohydrochloride Benzamide, N-(2-(diethylamino)ethyl)-2-methoxy-5-(methylsulfonyl)-, monohydrochloride
|
CAS | 51012-33-0
|
EINECS | 256-908-4 |
InChI | InChI=1/C15H24N2O4S.ClH/c1-5-17(6-2)10-9-16-15(18)13-11-12(22(4,19)20)7-8-14(13)21-3;/h7-8,11H,5-6,9-10H2,1-4H3,(H,16,18);1H |
TiapridHCl - Physico-chemical Properties
Molecular Formula | C15H25ClN2O4S
|
Molar Mass | 364.89 |
Melting Point | approximate 200℃ (dec.) |
Solubility | Very soluble in water, soluble in methanol, slightly soluble in anhydrous ethanol. |
Appearance | neat |
Color | White |
Merck | 14,9421 |
Storage Condition | 2-8°C |
Use | Used as an antipsychotic |
TiapridHCl - Risk and Safety
WGK Germany | 2 |
RTECS | CV4203800 |
TiapridHCl - Standard
Authoritative Data Verified Data
This product is N-[2-(diethylamino) ethyl]-5-(methanesulfonyl)-2-methoxybenzamide hydrochloride. Calculated as dry product, containing C15H24N204S • HC1 shall not be less than 98.5%.
Last Update:2024-01-02 23:10:35
TiapridHCl - Trait
Authoritative Data Verified Data
- This product is white needle-like crystalline powder; Odorless.
- This product is very soluble in water, slightly soluble in chloroform, slightly soluble in ethanol, almost insoluble in ether.
melting point
The melting point of this product (General 0612) is 198~202°C. Simultaneous decomposition during melting.
Last Update:2022-01-01 15:34:14
TiapridHCl - Preparation solution concentration reference
| 1mg | 5mg | 10mg |
---|
1 mM | 2.741 ml | 13.703 ml | 27.406 ml |
5 mM | 0.548 ml | 2.741 ml | 5.481 ml |
10 mM | 0.274 ml | 1.37 ml | 2.741 ml |
5 mM | 0.055 ml | 0.274 ml | 0.548 ml |
Last Update:2024-01-02 23:10:35
TiapridHCl - Differential diagnosis
Authoritative Data Verified Data
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update:2022-01-01 15:34:14
TiapridHCl - Exam
Authoritative Data Verified Data
clarity and color of solution
take 2.5g of this product, add 50ml of water to dissolve, the solution should be clarified; Take the above solution, check according to law (General rule 0901 second method), measure absorbance at the wavelength of 450nm, not more than 0.030.
acidity
take 2.5g of this product, add 50ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.0~6.0.
Related substances
take this product, add the mobile phase to dissolve and dilute to make a solution containing about lmg Tiapride hydrochloride in each lml, as a test solution; Take lml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, then take 1ml accurately, put it in a 10ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution. Take an appropriate amount of Tiapride hydrochloride, add water to dissolve and dilute to make a solution containing about 10 mg per 1ml, take 1ml, add 1ml of hydrogen peroxide test solution, heat for 30 minutes in water bath, let cool, dilute to 10ml with water, shake well as a system-suitable solution containing Tiapride nitrogen oxide (impurity I). Using octyl silane-bonded silica gel as filler (phenmenexluna C8, 0512 X 4.6mm, 5um or equivalent column) as determined by high performance liquid chromatography (general rule); in every 1000ml containing potassium dihydrogen phosphate 6.8g and sodium octane sulfonate 0.1g of solution (adjusted to pH 2.7 with phosphoric acid)-methanol-acetonitrile (80:15:5) as mobile phase; The detection wavelength was 240nm; The flow rate was 1.5ml per minute; the column temperature was 40°C. The system applicable solution 10u1 was injected into the human liquid chromatograph, and the chromatogram was recorded. The retention time of the sulfur peak was about 8.5 minutes, and the impurity I (the relative retention time was about 1.3). The degree of separation from sulfur peak should be greater than 4.0. 10 u1 of the control solution and 10 u1 of the test solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component chromatographic 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 more than 3 times (0.3%) of the main peak area of the control solution, and the chromatographic peaks with less than 0.5 times of the main peak area of the control solution in the chromatogram of the test solution are negligible (0.05%).
N,N-diethylethylenediamine
take about 0.4g of this product, weigh it accurately, put it in a 10ml measuring flask, add methanol to dissolve and dilute it to the scale, shake it well, and use it as a test solution, an appropriate amount of N-diethylethylenediamine reference substance was precisely weighed, dissolved with methanol and quantitatively diluted to prepare a solution containing about 40ug per 1 ml as a reference solution. According to the thin layer chromatography (General rule 0S02) test, take the above two Solutions 10 u1, respectively point on the same silica gel G thin layer plate, with concentrated ammonia-Dioxane-methanol-dichloromethane (2:10:14:90) is a developing solvent, which is developed (more than 12cm ), dried, sprayed with 0.2% ninhydrin-butanol solution, and heated at 100 ° C. For 15 minutes. Test solution such as N,N-diethyl ethylenediamine spot, the color of the main spot compared with the control solution, not deeper (0.1%).
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 15:34:15
TiapridHCl - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add glacial acetic acid 20ml to dissolve, plus acetic anhydride 20ml, according to the potential titration method (General rule 0701), with perchloric acid titration solution (O. 1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 36.49mg of C15H24N204S • HCl.
Last Update:2022-01-01 15:34:17
TiapridHCl - Category
Authoritative Data Verified Data
Last Update:2022-01-01 15:34:17
TiapridHCl - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 15:34:17
TiapridHCl - Tiapride hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of Tiapride hydrochloride. The content of Tiapride hydrochloride shall be calculated as Tiapride (C15H24N204S) and shall be 90.0% to 110.0% of the labeled amount.
trait
This product is a clear colorless 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
- the pH value should be 4.0 to 6.0 (General 0631).
- for related substances, take the test solution under the content determination item as the test solution; Take 1ml for precision measurement, put it in a 100m l measuring flask, and dilute it to the scale with mobile phase, shake well, then take 1ml accurately, put it in a 10ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as a control solution. According to the method under the item of related substances of Tiapride hydrochloride, from the "taking appropriate amount of Tiapride hydrochloride", check according to law, if there are impurity peaks in the chromatogram of the test solution, the single impurity peak area shall not be greater than the main peak area of the control solution (0.1%), and the sum of each impurity peak area shall not be greater than 3 times (0.3%) of the main peak area of the control solution, the main peak area of the test solution in the chromatogram is smaller than that of the control solution. 5 times of the chromatographic peak is negligible (0.05%).
- N, N-diethylethylenediamine take this product, quantitatively dilute it with methanol to make a solution containing about 36mg of sulfur-containing pyridinium per 1 ml, and shake it well to use it as a test solution, an appropriate amount of N-diethylethylenediamine reference substance was precisely weighed, dissolved with methanol and quantitatively diluted to prepare a solution containing about 40ug per 1 ml as a reference solution. According to the thin layer chromatography (General 0502) test, draw 10 u1 of the test solution and the reference solution, respectively, and put them on the same silica gel G thin layer plate, with concentrated ammonia-Dioxane-methanol-dichloromethane (2:10:14:90) as the developing solvent, it was developed (more than 12cm ), dried, sprayed with 0.2% ninhydrin-butanol solution, and heated at 100 ° C. For 15 minutes. Test solution such as N ,N-diethyl ethylenediamine spot, the color of the main spot compared with the control solution, not deeper (0.1%).
- bacterial endotoxin take this product, according to the law inspection (General 1143), the amount of endotoxin in each lmg of lypride should be less than 1.5 EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using octanosilane-bonded silica gel as filler (phenmenex luna C8,4.6mm X 250 mm,5um or equivalent chromatography column with potassium dihydrogen phosphate 6.8g per 1L with sodium octane sulfonate 0.1g of solution (adjusted to pH 2.7 with phosphoric acid)-fermentation-acetonitrile (80:15:5) as mobile phase; Detection wavelength was 287nm; Flow rate was 1.5ml per minute; the column temperature was 40°C.
- determination precision measure 2ml of this product, put it in a 100ml measuring flask, dilute it to the scale with water, shake it well, use it as a test solution, and inject 10u1 into human liquid chromatograph, record the chromatogram; Take an appropriate amount of Tiapride hydrochloride reference, accurately weigh, add water to dissolve and quantitatively dilute to make about 1 in 1 ml. lmg solution, the same method for determination. According to the external standard method to calculate the peak area, and the result is multiplied by 0.9, that is.
category
Same as Tiapride hydrochloride.
specification
2ml:lOOmg (based on C15H24N204S)
storage
light shielding, closed storage.
Last Update:2022-01-01 15:34:18