ETHODIN - Names and Identifiers
Name | Ethacridine Lactate
|
Synonyms | ACRINOL Acrinol ACRYNOL ETHODIN Rivanol Acrinol Hydrate ETHACRIDINE LACTATE Ethacridine Lactate 7-ethoxyacridine-3,9-diamine 2-ETHOXY-6,9-DIAMINOACRIDINE LACTATE 6,9-DIAMINO-2-ETHOXYACRIDINE LACTATE ETHACRIDINELACTATE(2-ETHOXY-6,9-DIAMINOACRIDINELACTATEHYDRATE)
|
CAS | 1837-57-6
|
EINECS | 217-408-1 |
InChI | InChI=1/C15H15N3O.C3H6O3/c1-2-19-10-4-6-13-12(8-10)15(17)11-5-3-9(16)7-14(11)18-13;1-2(4)3(5)6/h3-8H,2,16H2,1H3,(H2,17,18);2,4H,1H3,(H,5,6) |
ETHODIN - Physico-chemical Properties
Molecular Formula | C18H21N3O4
|
Molar Mass | 343.38 |
Density | 1.2764 (rough estimate) |
Melting Point | 235°C |
Boling Point | 478.66°C (rough estimate) |
Flash Point | 270.4°C |
Solubility | Dissolve in water, soluble in hot water, slightly soluble in ethanol, insoluble in ether |
Vapor Presure | 4.72E-11mmHg at 25°C |
Appearance | Yellow crystalline powder |
Storage Condition | under inert gas (nitrogen or Argon) at 2–8 °C |
Sensitive | Easy to absorb moisture and sensitive to air |
Refractive Index | 1.5855 (estimate) |
MDL | MFCD00013149 |
Physical and Chemical Properties | Yellow crystalline powder, odorless, bitter. Soluble in water, soluble in hot water, slightly soluble in ethanol, insoluble in ether. The structural formula is shown in the figure below: |
ETHODIN - Standard
Authoritative Data Verified Data
This product is 6, 9-diamino-2-ethoxyacridine lactate hydrate. Calculated as dry product, containing not less than 99.0% of C15H15N30 • C3H603.
Last Update:2024-01-02 23:10:35
ETHODIN - Trait
Authoritative Data Verified Data
- This product is yellow crystalline powder; Odorless.
- This product is soluble in hot water, soluble in boiling anhydrous ethanol, slightly soluble in water, slightly soluble in ethanol, insoluble in ether.
Last Update:2022-01-01 13:36:53
ETHODIN - Differential diagnosis
Authoritative Data Verified Data
- take about 0.lg of this product, add 10ml of water, dissolve it, add sodium hydroxide solution to make it alkaline, that is, precipitate yellow precipitate, filter, the filtrate was added with 2ml of 0.5mol/L sulfuric acid solution and several drops of potassium permanganate solution, which showed purplish red color, and the color disappeared after heating.
- take about 50mg of this product, add 5ml of water, dissolve it, add dilute hydrochloric acid to make it acidic, and add 1 ml of Sodium Nitrite test solution to show cherry red.
- take the aqueous solution of this product (1-2000) and add several drops of Iodine test solution, which will produce dark blue-green precipitate. When human ethanol is added, the precipitate disappears.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 971).
Last Update:2022-01-01 13:36:53
ETHODIN - Exam
Authoritative Data Verified Data
acidity
take 0.lg of this product, add 100ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 6.0~7.0.
clarity and color of solution
take 0.20g of this product, Add 10ml of fresh boiling water and cold to 50°C to dissolve, and the solution should be clear. 5ml of this solution was diluted with water to 10ml, and the color should not be darker than that of the control solution (9.5ml of 1% trinitrophenol solution was mixed with 0.22mL of ferric chloride solution and 0.28ml of water for color comparison).
chloride
take this product l. Add 10ml of sodium hydroxide solution, dilute to 100ml with water, shake, mix well, place for 30 minutes, filter, take 20ml of continued filtrate, add 7ml of dilute nitric acid and 1 ml of silver nitrate test solution, add appropriate amount of water to make 50ml, and check according to law (General rule 0801). Compared with the control solution made of 5ml of standard gasification sodium solution, it should not be more concentrated (0.025%).
sulfate
Take 20ml of the above filtrate, add 1.5ml of water and 0802 ml of dilute hydrochloric acid, and check according to law (General rule 0.5%). Compared with the control solution made of 10ml of standard potassium sulfate solution, it should not be deeper ().
Related substances
take about 25mg of this product, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, and use it as a test solution. Take 1 ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the high performance liquid chromatography (General 0512) test, silica gel was bonded with eighteen alkyl silane as the filler; The solution containing 0.1% sodium octane sulfonate [phosphate buffer solution (take 7.8g of sodium dihydrogen phosphate, add of water to dissolve, the pH was adjusted to 2.8 with phosphoric acid and diluted to 700 ml with water)-acetonitrile (300:)] as mobile phase; The detection wavelength was 270nm. The theoretical plate number is not less than 3000 calculated as the ethacridine peak. Take 10ul of test solution and control solution respectively, inject human liquid chromatograph, record chromatogram to 3 times of the retention time of main component peak, if there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.3 times (0.3%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss should be in 4.5% ~ 5.5% (General 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 ignition residue item shall not contain more than 30 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update:2022-01-01 13:36:54
ETHODIN - Content determination
Authoritative Data Verified Data
take this product about 0.27g, precision weighing, add anhydrous formic acid 5.0ml to dissolve, add glacial acetic acid 60ml, according to the potentiometric titration method (General rule 0701), with high oxygen acid titration solution (0.1 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 34.34mg of C15H15N30. C3H603.
Last Update:2022-01-01 13:36:54
ETHODIN - Category
Authoritative Data Verified Data
Last Update:2022-01-01 13:36:55
ETHODIN - Storage
Authoritative Data Verified Data
Last Update:2022-01-01 13:36:55
ETHODIN - Ethacridine Lactate Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of ethacridine lactate. Containing ethacridine lactate (C15H15N30 • C3H603) shall be 93.0% to 107.0% of the label amount.
trait
This product is yellow clear liquid.
identification
- take about 2ml of this product, add dilute hydrochloric acid to make it acidic, and add 1ml Sodium Nitrite test solution to show cherry red color.
- take about 4ml of this product, add sodium hydroxide test solution to make it alkaline, that is, precipitate yellow precipitate, filter, add sulfuric acid solution (3-100) 2ml and potassium permanganate test solution several drops of filtrate, that is, purplish red, the color disappeared after heating.
- take an appropriate amount of this product, add water to dilute it into a solution containing 5ug per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), at 206nm, there is a maximum absorption at the wavelength of 269nm and 362nm.
examination
- the pH value should be 5.5 to 7.0 (General 0631).
- the color of the solution precision amount of this product 2ml, diluted with water to 10ml, and the control solution (take 9.5 of 1% trinitrate phenol solution, the color shall be made by mixing 0.22ml of potassium dichromate solution with 0.28ml of water) for comparison, and the color shall not be darker.
- Related substances take 1 ml of this product, put it in a 50ml measuring flask, dilute it to the scale with mobile phase, shake it, and use it as a test solution. Take 1 ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Determine according to the method under the item of ethacridine lactate related substances, if there are impurity peaks in the chromatogram of the test solution, aminopyrine peak shall be subtracted if aminopyrine is contained in auxiliary materials. The area of single impurity peak shall not be greater than 0.3 times (0.3%) of the area of main peak of control solution, and the sum of each impurity peak area shall not be greater than the area of main peak of control solution (1.0%).
- the bacterial endotoxin content of this product shall be less than 1.0EU per 1 mg of ethacridine lactate (calculated as C15H15N30 • C3H603) after inspection according to law (General rule 1143).
- 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 0.1% sodium octane sulfonate solution [phosphate buffer solution (take sodium dihydrogen phosphate 7.8g, add water 900ml to dissolve, the pH value was adjusted to 2.8 with phosphoric acid, and diluted to 700 ml with water to obtain acetonitrile (300:)] as mobile phase; The detection wavelength was 270mn. The number of theoretical plates shall not be less than 3000 based on the calculation of ethacridine peak,
- determination of precision: take an appropriate amount of this product and dilute it with mobile phase to prepare ethacridine lactate (based on C15H15N30 • C3H603) per 1 ml. lmg solution was used as the test solution; lOul was accurately measured, injected into the liquid chromatograph, and the chromatogram was recorded, add the mobile phase to dissolve and dilute to make an O per 1 ml. lmg solution, the same method of determination, according to the external standard method to calculate the peak area, that is.
category
Same as ethacridine lactate.
specification
2ml:50mg (calculated as C15H15N30 • C3H603)
storage
light shielding, closed storage.
Last Update:2022-01-01 13:36:56
ETHODIN - Ethacridine lactate solution
Authoritative Data Verified Data
This product is an aqueous solution of ethacridine lactate. Containing ethacridine lactate (C15H15N30 • C3H603) shall be between 93.0% and 107.0% of the label amount.
trait
This product is a yellow clear liquid.
identification
- take about 10ml of this product, add dilute hydrochloric acid to make it acidic, and add 1 ml of Sodium Nitrite test solution to show cherry red color.
- take about 10ml of this product, add sodium hydroxide test solution to make it alkaline, that is, precipitate yellow precipitate, filter, add sulfuric acid solution (3-100)2ml and potassium permanganate test solution several drops of filtrate, that is, purplish red, the color disappeared after heating.
examination
- the pH value should be 5.0 to 7.5 (General 0631).
- loading capacity take this product, according to the minimum loading capacity inspection method (General 0942) inspection, should comply with the provisions.
- microbial limit take this product as non-sterile product microbial limit test: microbial count method (General 1105) and control bacteria test method (General 1106) and non sterile drugs microbial limit standard (General 1107) inspection, should meet the requirements.
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 a solution containing 0.1% sodium octane sulfonate [phosphate buffer solution (take sodium dihydrogen phosphate 7.8g, add water 900ml to dissolve, the pH value was adjusted to 2.8 with phosphoric acid, and diluted to 700 ml with water to obtain acetonitrile (300:)] as mobile phase; The detection wavelength was 270nm. The theoretical plate number is not less than 3000 calculated as the ethacridine peak.
- determination of precision: take an appropriate amount of this product and dilute it with mobile phase to prepare ethacridine lactate (based on C15H15N30 • C3H603) per 1 ml. lmg solution, as a test solution; Take 10 u1 for precision measurement, inject human liquid chromatograph, record chromatogram; Take appropriate amount of ethacridine lactate reference, add the mobile phase to dissolve and dilute to make each 1 ml containing 0.lmg solution, the same method of determination, according to the external standard method to calculate the peak area, that is.
category
Same as ethacridine lactate.
specification
0.1% (according to C15H15N30 • C3H603)
storage
light shielding, closed storage.
Last Update:2022-01-01 13:36:57