Dipyridan - Names and Identifiers
Name | Dipyridamole
|
Synonyms | Coroxin Corosan Curantyl Dipyridan Dipiridamol Dipyridamole Dypyridamole Dipyridamine Dipyridamole (FDA) Dipyridamole (200 mg) 2,2,2,2-(4,8-dipiperidinopyrimido(5,4-d)pyrimidine-2,6-diyl)dinitrilotetraethanol 1,1',1'',1'''-{[4,8-di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,6-diyl]dinitrilo}tetraethanol 2,2',2'',2'''-((4,8-Di(piperidin-1-yl)pyrimido[5,4-d]-pyrimidine-2,6-diyl)bis(azanetriyl))tetraet
|
CAS | 58-32-2
|
EINECS | 200-374-7 |
InChI | InChI=1/C24H40N8O4/c1-15(33)31(16(2)34)23-25-19-20(21(27-23)29-11-7-5-8-12-29)26-24(32(17(3)35)18(4)36)28-22(19)30-13-9-6-10-14-30/h15-18,33-36H,5-14H2,1-4H3 |
Dipyridan - Physico-chemical Properties
Molecular Formula | C24H40N8O4
|
Molar Mass | 504.63 |
Density | 1.2046 (rough estimate) |
Melting Point | 165-166 °C (lit.) |
Boling Point | 593.96°C (rough estimate) |
Flash Point | 396.09°C |
Water Solubility | Soluble in chloroform, methanol, dilute acids, ethanol. Slightly soluble in water. |
Solubility | DMSO 101 mg/mL;Water <1 mg/mL;Ethanol 50 mg/mL. Easily soluble in methanol, ethanol, chloroform, soluble in dilute acid below pH3.3, not very soluble in acetone, benzene, ethyl acetate, slightly soluble in water. The solution is |
Vapor Presure | 0mmHg at 25°C |
Appearance | Yellow powder |
Color | yellow |
Merck | 14,3346 |
pKa | pKa 6.4 (Uncertain) |
Storage Condition | room temp |
Stability | Stable for 1 year from date of purchase as supplied. Solutions in DMSO or ethanol may be stored at -20°C for up to 3 months. |
Refractive Index | 1.6910 (estimate) |
MDL | MFCD00010555 |
Physical and Chemical Properties | Yellow crystalline powder. Melting point of 163 ° C, soluble in chloroform and dilute acid, soluble in ethanol, acetone-soluble, almost insoluble in water. No odor, slightly bitter taste. |
Use | Anti-platelet aggregation drug, coronary artery dilator, for the prevention of recurrence of myocardial infarction and angina pectoris |
Dipyridan - Risk and Safety
Hazard Symbols | Xi - Irritant
|
Risk Codes | 36/37/38 - Irritating to eyes, respiratory system 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 | 2 |
RTECS | KK7450000 |
HS Code | 29335990 |
Toxicity | LD50 in rats: 8.4 g/kg orally; 208 mg/kg i.v. (Takenaka) |
Dipyridan - Standard
Authoritative Data Verified Data
This product is 2,2 ',2 ",2"-[(4, 8-dipiperidinopyrido [5,4-d] pyrimidin-2, 6-diyl) double nitrogen-based]-four ethanol. The content of C24H40N804 shall be between 98.0% and 102.0% based on the dry product.
Last Update:2024-01-02 23:10:35
Dipyridan - Trait
Authoritative Data Verified Data
- This product is yellow crystalline powder; Odorless.
- This product is soluble in chloroform, soluble in ethanol, slightly soluble in acetone, almost insoluble in water; Soluble in dilute acid.
melting point
The melting point of this product (General 0612) is 162~1681.
Last Update:2022-01-01 11:33:39
Dipyridan - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add ethanol to dissolve, that is, green fluorescence, fluorescence disappeared after adding acid.
- take about 10 mg of this product, add 2ml of dilute hydrochloric acid to dissolve, drop 1% potassium chromate solution, that is, red and purple; After shaking, the red and purple color will disappear, and add 1% excess potassium chromate solution, red-purple color was not reproduced.
- take this product, add 0. The Olmol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing 10ug per 1 ml, and the maximum absorption was measured by UV-visible spectrophotometry (General 0401) at the wavelength of 283mn.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 557).
Last Update:2022-01-01 11:33:40
Dipyridan - Exam
Authoritative Data Verified Data
chlorine-containing compounds
take about 20mg of this product, according to the oxygen flask combustion method (General rule 0703) for organic damage, 0.4% sodium hydroxide solution 20ml as the absorption liquid, once the combustion is completed, strong shaking for 15 minutes, add 10ml of dilute nitric acid, move to 50ml Nessler's colorimetric tube, check according to the chloride inspection method (General 0801), and operate with the control solution (the same method as the test sample), however, the test article is not contained in the filter paper during combustion, and 4.0 of standard sodium chloride solution is added), and it should not be more concentrated (0.20%).
Related substances
take this product, add methanol to dissolve and dilute to make 1.0 mg of the solution was used as a test solution, and an appropriate amount was quantitatively diluted with methanol to prepare a solution containing 10ug per 1 ml as a control solution. According to the high performance liquid chromatography (General rule 0512) test, with eighteen alkyl silane bonded silica gel as filler; Disodium hydrogen phosphate solution [take disodium hydrogen phosphate 250mg, add water 250ml, dissolve, Dropwise add phosphoric acid solution (1-3) the pH value was adjusted to 4.6]-methanol (25:75) as the mobile phase; The detection wavelength was 288nm, and the number of theoretical plates was not less than 600 based on the dipyridamole peak. The LOLs of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was 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%).
residual solvent
take about 0.1g of this product, precision weighing, in the top empty bottle, Precision Add 5ml of N,IV-dimethylformamide to dissolve, seal, as a test solution; Separately take methanol, appropriate amount of acetone and ethyl acetate, precision weighing, quantitative dilution with N,N-dimethylformamide to make solution containing about 50ug in each lml, precision measuring 5ml, in the empty bottle, sealed, as a control solution. Test as residual solvent assay (General 0861 second method). With 6% cyanopropylphenyl-94% dimethylpolysiloxane (or polar similar) as the stationary liquid; The initial temperature is 50°C, maintained for 3 minutes, and the temperature is raised to 160°C at a rate of 40°C per minute, maintained for 3 minutes; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibrium temperature was 80°C and the equilibrium time was 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the external standard method to calculate the peak area, methanol, acetone and ethyl acetate residues should be in accordance with the provisions.
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 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update:2022-01-01 11:33:40
Dipyridan - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add dilute hydrochloric acid 50ml dissolved, with potassium bromate titration solution (0.01667mol/L) slow titration, near the end point, the end point is the end point when the person is shaken and added dropwise at that time until there is no more red-purple color, which is equivalent to 25.23mg of C24H40N8O4 per 1 ml of potassium bromate titration solution (0.016 67mol/L).
Last Update:2022-01-01 11:33:41
Dipyridan - Category
Authoritative Data Verified Data
Anti-platelet aggregation drugs, coronary artery expansion drugs.
Last Update:2022-01-01 11:33:42
Dipyridan - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 11:33:42
Dipyridan - Dipyridamole Tablets
Authoritative Data Verified Data
This product contains dipyridamole (C24H40N304) should be 90.0%-110.0% of the label.
trait
This product is sugar-coated tablet or film-coated tablet, which shows yellow color after removing the coating.
identification
- take this product, remove the coating, grind, weigh an appropriate amount (about 0.2g equivalent to dipyridamole), add three methane 20ml, stir, dissolve dipyridamole, filter, the solution was evaporated to dryness on a water bath, and the residue was subjected to the identification (1) and item test under the item of dipyridamole, 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.
- take an appropriate amount of fine powder of this product (about equivalent to dipyridamole lOOmg), add 10ml of chloroform, grind and dissolve, filter, evaporate the filtrate to dryness, dry the residue under reduced pressure, and determine it according to law. The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 557 figure).
examination
- Content uniformity take 1 tablet of this product, remove the coating, grind it, and use 0.Olmol/L hydrochloric acid solution was transferred to a 100ml measuring flask and added 0.Olmol/L hydrochloric acid solution, shaking to dissolve dipyridamole, and 0. Dilute Olmol/L hydrochloric acid solution to the scale, shake well, filter, take the continuous filtrate accurately, use 0.Olmol/L hydrochloric acid solution is diluted quantitatively to prepare a solution containing about 10ug of dipyridamole per 1 ml, and the absorbance is measured at the wavelength of 283nm by ultraviolet-visible spectrophotometry (General rule 0401), the content, calculated as the absorption coefficient of C24H40N804 is 625, shall be in accordance with the provisions (General 0941).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate according to law, after 30 minutes, take 10ml of solution, filter, take the appropriate amount of filtrate with precision, dilute quantitatively with dissolution medium to prepare 10ug of dipyridamole solution per lml, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 283nm, and the appropriate amount of dipyridamole control was taken, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 10ug of dipyridamole per 1 ml. The absorbance was measured by the same method, and the dissolution amount of each tablet was calculated. 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; With disodium hydrogen phosphate solution [take disodium hydrogen phosphate l. After dissolving in 1000ml of water, add Dropwise phosphoric acid solution (1-3) To adjust the p H value to 4. 6]-methanol (25 : 75) is the mobile phase; The detection wavelength is 288nm, and the number of theoretical plates is not less than 1000 according to the dipyridamole peak. The resolution of dipyridamole peak and adjacent impurity peaks should meet the requirements.
- determination of this product 20 tablets, remove the coating, precision weighing, fine, precision weighing an appropriate amount (equivalent to dipyridamole 50mg), 100ml flask, add water 10ml, sonicate for about 15 minutes, add 75ml veratryl alcohol, shake for about 30 minutes to dissolve dipyridamole, dilute with methanol to scale, shake, filter, take 2ml continuous filtrate with precision, put it in 25ml measuring flask, dilute to the scale with mobile phase, shake well, as a test solution, take 20 u1 with precision, inject into liquid chromatograph, record chromatogram; Take an appropriate amount of dipyridamole reference, weigh accurately, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing 40ug 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 dipyridamole.
specification
25mg
storage
light shielding, sealed storage.
Last Update:2022-01-01 11:33:43
Dipyridan - Dipyridamole injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of Dipyridamole. Dipyridamole-containing (C24H40N604) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is yellow clear liquid, with fluorescence.
identification
- take 2ml of this product, add 2ml of dilute hydrochloric acid, drop add 1% potassium chromate solution, that is, red-purple, after shaking, red-purple fading, add an excess of 1% potassium chromate solution, red-purple color was not reproduced.
- take 1ml of this product and dilute it with 20ml of water to show green fluorescence. After adding acid
- fluorescence disappeared.
- 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
- the pH value should be 2.5 to 4.5 (General 0631).
- Related Substances: dilute the product with mobile phase to prepare a solution containing about 1 mg of dipyridamole per 1 ml as a test solution, A solution containing 10ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 2 times (2.0%) the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 4.5 times (4.5%) of the main peak area of the control solution.
- bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin per 1 mg dipyridamole should be less than 8.8EU.
- 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 eighteen alkyl silane bonded silica gel as filler; With acetate buffer (sodium acetate 6.8g, dissolved in water and diluted to 1000ml, the pH was adjusted to 5.1±0.1 with acetic acid-methanol (35:65) as the mobile phase; The detection wavelength was 276mn. The number of theoretical plates shall not be less than 2000 calculated by the peak of dipyridamole, and the degree of separation of the peak of dipyridamole from the adjacent impurity peaks shall meet the requirements.
- determination of precision: take an appropriate amount of this product (about 10mg equivalent to dipyridamole), put it in a 50ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as a test solution, l0ul was accurately measured and injected into human liquid chromatograph, and the chromatogram was recorded. The appropriate amount of dipyridamole reference substance was accurately weighed, dissolved and diluted with mobile phase to prepare a solution containing about 0.2mg 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 dipyridamole.
specification
2ml : 10mg
storage
light shielding, closed storage.
Last Update:2022-01-01 11:33:44
Dipyridan - Dipyridamole sustained-release capsules
Authoritative Data Verified Data
This product contains dipyridamole (C24H40N804) should be 93.0% to 107.0% of the label.
trait
The content of this product is light yellow pellets.
identification
- take an appropriate amount of fine powder of this product (about 10mg equivalent to dipyridamole), add ethanol to dissolve, the solution shows green fluorescence, and the fluorescence disappears after adding acid.
- take an appropriate amount of the fine powder of this product (about equivalent to dipyridamole lOmg), add 5ml of dilute centistokes acid, shake, dissolve dipyridamole, filter, take 3ml of the filtrate, 1% potassium chromate solution was added dropwise, which showed red and purple color. After shaking, the red and purple color disappeared, and the red and purple color was not reproduced by adding 1% excess potassium chromate.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of Nm.
examination
- Content uniformity: Take 1 granule of this product, pour out the content, and measure and calculate the content according to the method under the content determination item, starting from "placing in a beaker, the provisions shall be met (General rule 0941).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931-method), with hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate in accordance with the law, after 1 hour, 3 hours, 7 hours, take 10ml of each solution, and immediately add the same temperature, the same volume of dissolution medium, filtration, precise amount of filtrate, the dissolution medium was quantitatively diluted to prepare a solution containing about 10ug of dipyridamole per 1 ml, and the absorbance was measured at a wavelength of 0401 mn according to UV-visible spectrophotometry (general). An appropriate amount of dipyridamole reference substance was added, and the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 10% per 1 ml, which was determined by the same method. The elution amount of each particle at different times was calculated separately. The dissolution amount of each capsule of this product at 1 hour, 3 hours and 7 hours shall be 5% ~ 30%, 40% ~ 65% and more than 75% of the labeled amount, and shall comply with the regulations.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
Take 20 capsules of this product, accurately weigh, calculate the average loading, take the content, mix evenly, grind fine, accurately weigh the appropriate amount (about 50mg equivalent to dipyridamole), put it in the beaker, add 0. A proper amount of Olmol/L hydrochloric acid solution was placed in a hot water bath, stirred to dissolve dipyridamole, allowed to cool, transferred to a 100ml measuring flask quantitatively, diluted to the scale with the above solvent, shaken, filtered, the filtrate was quantitatively diluted with the above solvent to prepare a solution containing about 10ug per 1 ml, and the absorbance was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general). Calculated as the absorption coefficient of C24H40N804 is 625.
category
Same as dipyridamole.
specification
25mg
storage
shade, seal, and store in a cool place.
Last Update:2022-01-01 11:33:44
Dipyridan - Reference Information
NIST chemical information | information provided by: webbook.nist.gov (external link) |
biological activity | Dipyridamole (Persantine, NSC-515776) is a phosphodiesterase inhibitor, inhibits the uptake and metabolism of adenosine. |
Target | Value |
Use | a coronary vasodilator for the treatment of angina pectoris, myocardial infarction, etc. Anti-platelet aggregation drug, coronary artery dilator, for the prevention of recurrence of myocardial infarction and angina pectoris, etc. |
production method | amino orotic acid (see 02470) is obtained by cyclization, chlorination and condensation. |
Last Update:2024-04-09 19:05:13