Irsogladine Maleate
Irsogladine Maleate
CAS: 84504-69-8;57381-28-9;57381-33-6
Molecular Formula: C13H11Cl2N5O4
Irsogladine Maleate - Names and Identifiers
| Name | Irsogladine Maleate |
| Synonyms | Gaslon Irsogladine Maleate Dicloguamine maleate 2,4-Diamino-6-(2,5-dichlorophenyl)-s-triazine maleate 6-(2,5-Dichlorophenyl)-1,3,5-triazine-2,4-diamine maleate 2,4-diamino-6-(2,5-dichlorophenyl)-1,3,5-triazine maleate 6-(2,5-Dichlorophenyl)-1,3,5-triazine-2,4-diamine (Z)-2-butenedioate 6-(2,5-dichlorophenyl)-1,3,5-triazine-2,4-diamine (2Z)-but-2-enedioate |
| CAS | 84504-69-8 57381-28-9 57381-33-6 |
| InChI | InChI=1/C9H7Cl2N5.C4H4O4/c10-4-1-2-6(11)5(3-4)7-14-8(12)16-9(13)15-7;5-3(6)1-2-4(7)8/h1-3H,(H4,12,13,14,15,16);1-2H,(H,5,6)(H,7,8)/b;2-1- |
Irsogladine Maleate - Physico-chemical Properties
| Molecular Formula | C13H11Cl2N5O4 |
| Molar Mass | 372.16 |
| Melting Point | 181-182℃ |
| Boling Point | 552.2°C at 760 mmHg |
| Flash Point | 287.8°C |
| Vapor Presure | 3.07E-12mmHg at 25°C |
| Physical and Chemical Properties | Melting point 181-182°C |
| Use | Drug for the treatment of gastric ulcer disease |
Irsogladine Maleate - Standard
Authoritative Data Verified Data
This product is 2, 4-diamino-6-(2, 5-dichlorophenyl) -1, 3, 5-triphenylmaleate. Calculated as dry product, containing C9H7C12N5 • C4H404 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
Irsogladine Maleate - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline or crystalline powder.
- This product is slightly soluble in ethylene glycol, slightly soluble in methanol or anhydrous ethanol, almost insoluble in water; Slightly soluble in glacial acetic acid.
melting point
The melting point of this product (General rule 0612) is 181~186°C, and it is decomposed at the same time during melting.
Last Update：2022-01-01 11:31:32
Irsogladine Maleate - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 4ml of water and lml of dilute hydrochloric acid to dissolve, add 3 drops of potassium permanganate test solution, and the purple color will disappear.
- take about 10mg of this product, add 4ml of water and lml of dilute hydrochloric acid to dissolve, and add 2ml of ammonium chromium thiocyanate test solution to produce light red precipitate.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 905).
Last Update：2022-01-01 11:31:32
Irsogladine Maleate - Exam
Authoritative Data Verified Data
acidity
Take 20mg of this product, add 100ml of water, heat to 80°C, cool, filter, take the filtrate, according to the law (General 0631),pH value should be 2.0.
chloride
take 0.5g of this product, add 35ml of water and 15ml of dilute nitric acid, heat it to dissolve, let it cool until the precipitate is completely precipitated, filter it, take 25ml of continued filtrate, and check it according to law (General rule 0801), compared with the control solution made of 0.04% of standard sodium chloride solution, it should not be more concentrated ().
Related substances
take this product, add ethylene glycol to dissolve and dilute to make a solution containing about 5mg per lml, as a test solution; Take an appropriate amount of precision, A solution containing 5ug per 1 ml was prepared as a control solution by quantitative dilution with ethylene glycol. Determined by high performance liquid chromatography (General 0512). Silica gel bonded with eighteen alkyl silane was used as filler; 0.1% methanesulfonic acid solution-methanol (80:20) was used as mobile phase; The detection wavelength was 250nm; The column temperature was 40°C. Take 50mg of this product and 10mg of methyl paraben, put it in the same 20ml measuring flask, add ethylene glycol to dissolve and dilute to the scale, shake well, take 5ml, put it in 100ml measuring flask, dilute to scale with ethylene glycol, shake well, inject lOul into the liquid chromatograph, record the chromatogram, and the separation degree of the peak of isolidine and the peak of p-Hydroxybenzoic acid should be greater than 8. The LOLs of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.1%), and the sum of each impurity peak area shall not be greater than 3 times the area of the main peak of the control solution (0.3%).
loss on drying
take this product and dry it at 105°C for 4 hours, and the 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 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 11:31:34
Irsogladine Maleate - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add glacial acetic acid and acetic anhydride 25ml, shake to dissolve, according to the potential titration method (General 0701), with perchloric acid titration solution (0.1 mol/L) titration, and the titration results were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 37.22mg of C9H7Cl2N5. C4H404.
Last Update：2022-01-01 11:31:34
Irsogladine Maleate - Category
Authoritative Data Verified Data
gastric mucosal protective drugs.
Last Update：2022-01-01 11:31:35
Irsogladine Maleate - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:31:35
Irsogladine Maleate - Irsogladine Maleate Tablets
Authoritative Data Verified Data
This product should contain 93.0% ~ 107.0% of the label amount of isoratine Maleate (C9H7C12N5 • C4H404).
trait
This product is white or off-white.
identification
- take an appropriate amount of the fine powder of this product (about 2mg equivalent to 2mg of isolatine maleate), add 2ml of methanol and 3ml of 2-methoxyethanol, shake it for 10 minutes to dissolve the powder, and centrifuge it, the supernatant was taken as the test solution; In addition, 2mg of a control substance of isoradine maleate was taken, 2ml of methanol was added, and 3ml of 2-methoxyethanol was added thereto for dissolution by shaking, and the solution was taken as the control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of each lol, respectively, on the same silica gel GF254 thin layer plate, with petroleum ether-acetone-glacial acetic acid (12:4:1) for the development of the solvent, expand, dry, set the UV light (254nm) under the view. 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.
- take an appropriate amount of the fine powder of this product (about 10mg equivalent to isoparatine maleate), put it in a 100ml measuring flask, add 0.lmol/L hydrochloric acid solution appropriate amount, shake to dissolve isoradine maleate, dilute to the scale with the above solvent, shake, filter, take the filtrate, continue with 0.1 mol/L hydrochloric acid solution was diluted to prepare a solution containing about isolidine maleate Ridge g per 1 ml as a test solution. 1 mol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 4ug per 1 ml as a reference solution. According to UV-visible spectrophotometry (General 0401) determination, the maximum absorption wavelength of the test solution should be consistent with the maximum absorption wavelength of the reference solution.
- ( 1) and (2) are selected as one item.
examination
- Content uniformity take 1 tablet of this product, put it in a 20ml measuring flask (2mg specification) or a 50ml measuring flask (4mg specification), add water-glacial acetic acid (400:3)8ml, sonication to disperse completely, adding appropriate amount of methanol, sonication to dissolve isoratadine maleate, let it cool, dilute to scale with methanol, shake, filter, the content of the continued filtrate shall be determined according to the method under the content determination item, and shall comply with the regulations (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 30 minutes, the appropriate amount of the solution was filtered, and the filtrate was taken as the test solution. Another 10mg of the reference substance of isoradine maleate was weighed accurately, and the solution was placed in a 50ml measuring flask, and 30ml of methanol was added for ultrasonic dissolution, cool, dilute to the scale with water, shake, take an appropriate amount of precision, dilute with water and make a solution containing about (2mg specification) or 4mg (4mg specification) per 1 ml, as a control solution. According to the chromatographic conditions under the content measurement, the detection wavelength was 230mn. The sample solution and the reference solution of 50 u1 were respectively injected into the liquid chromatograph, and the chromatogram was recorded. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 80% 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-water-glacial acetic acid (600:400:3) as mobile phase; The detection wavelength was 265mn. The number of theoretical plates shall not be less than 2000 based on the calculation of the peak of isolatine.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to 10mg of isopetadine maleate), put in a 100ml measuring flask, add an appropriate amount of mobile phase, ultrasonic dissolution of isopetadine maleate, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, and inject 20u1 into the liquid chromatograph to record the chromatogram, the mobile phase was added for dissolution and quantitative dilution to make about 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
.
specification
(l)2mg (2)4mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 11:31:36
