1953-04-4 - Names and Identifiers
Name | galanthamine hydrobromide
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Synonyms | GALANTAMINE HBR Galantamine Hbr GALANTHAMINE HBR Galanthamine HBr jilkonhydrobromide lycoreminehydrobromide galantamine hydrobromide GALANTHAMINE HYDROBROMIDE galanthamine hydrobromide galanthaminehydrogenbromide 3,2-efg)(2)benzazocin-6-ol,1,2,3,4,6,7,7a,11c-octahydro-9-methoxy-benzofuro( 1,2,3,4,6,7,7a,11c-octahydro-9-methoxy-2-methyl-benzofuro(4,3,2-efg)(2)benza 5-Methoxy-9-methyl-2,3,3a,3a1,8,9,10,11-octahydro-4-oxa-9-azacycloocta[def]fluoren-2-ol hydrobromide (4aS,6R,8aS)-6-hydroxy-3-methoxy-11-methyl-5,6,9,10,11,12-hexahydro-4aH-[1]benzofuro[3a,3,2-ef][2]benzazepin-11-ium
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CAS | 1953-04-4 69353-21-5
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EINECS | 217-780-5 |
InChI | InChI=1/C17H21NO3/c1-18-8-7-17-6-5-12(19)9-14(17)21-16-13(20-2)4-3-11(10-18)15(16)17/h3-6,12,14,19H,7-10H2,1-2H3/p+1/t12-,14-,17-/m0/s1 |
1953-04-4 - Physico-chemical Properties
Molecular Formula | C17H22BrNO3
|
Molar Mass | 368.27 |
Melting Point | 256°C |
Boling Point | 439.336°C at 760 mmHg |
Specific Rotation(α) | (C=1.4, H2O)-95;D20 -93.1° (c = 0.1015 in 15 ml H2O) |
Flash Point | 219.503°C |
Solubility | Soluble in water, slightly soluble in ethanol, insoluble in chloroform and ether. |
Vapor Presure | 0mmHg at 25°C |
Appearance | White powder |
Storage Condition | Sealed in dry,Room Temperature |
MDL | MFCD00067672 |
Use | For nervous system diseases and movement disorders caused by trauma, multiple neuritis, radiculitis, etc |
1953-04-4 - Risk and Safety
Hazard Symbols | T - Toxic
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Risk Codes | 25 - Toxic if swallowed
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Safety Description | 45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
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UN IDs | UN 2811 6.1/PG 3 |
WGK Germany | 3 |
RTECS | DF8075000 |
Hazard Class | 6.1(b) |
Packing Group | III |
1953-04-4 - Standard
Authoritative Data Verified Data
This product is (4aS,6R,8aR)-11-methyl -3-methoxy-4a, 5,9,10,11,12-hexahydro-6 H-benzofurano [3a,3,2-ef][2] benzoazepine-6-ol hydrobromide. Calculated as dry product, the content of C17H21N03 • HBr shall not be less than 98.0%.
Last Update:2024-01-02 23:10:35
1953-04-4 - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is dissolved in water, slightly soluble in ethanol, insoluble in acetone, chloroform, ether.
specific rotation
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20mg per lml, and determine according to law (General 0621), the specific rotation was -90 ° to -100 °.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 50ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of NM, and the absorption coefficient was 79.6 to 86.2.
Last Update:2022-01-01 13:42:23
1953-04-4 - Differential diagnosis
Authoritative Data Verified Data
- take about 1 mg of this product, put it in a porcelain evaporation dish, add 1ml of 0.5% ammonium molybdate solution, steam dry on a water bath, and add 1-2 drops of sulfuric acid to show blue-green color.
- take this product and Galanthamine Hydrobromide reference, respectively, with the relevant substances under the mobile phase dissolved and diluted to make each lml containing about 0. The lmg solution is used as the test solution and the reference solution, and 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 according to the chromatographic conditions of the related substances.
- the product of the aqueous solution of the identification of bromide reaction (General 0301).
Last Update:2022-01-01 13:42:24
1953-04-4 - Exam
Authoritative Data Verified Data
acidity
take the solution under the clarity of the solution, measured by law (General 0631), the pH value should be 4.5~6.5.
clarity of the solution
take 0.10g of this product and add 10ml of water to dissolve. The solution should be clarified.
Related substances
take this product, add mobile phase to dissolve and quantitatively dilute to prepare a solution containing lmg per lml as a test solution; Take 1ml 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 determination of high performance liquid chromatography (General rule 0512), with eighteen alkyl silane bonded silica gel as filler, with triethylamine phosphate buffer solution (take triethylamine 7ml, add water 900ml, the pH value was adjusted to 0.5 with 6.0 mol/L phosphoric acid solution, and water was added to ML)-methanol (75:25) as mobile phase, and the detection wavelength was 228nm. Take an appropriate amount of likelamine hydrobromide and dilute it with the above test solution to make about 0 ml/ml of likelamine hydrobromide. For the mixed solution of lmg and Galanthamine Hydrobromide (about lmg), take 20u1 and inject it into the liquid chromatograph. The separation degree of the peak and the main component peak should meet the requirements. 20ul of the above control solution and 20ul 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 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 (1.0% ) , the sum of each impurity peak area shall not be greater than 2 times (2.0%) 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 1.0% (General rule 0831).
Last Update:2022-01-01 13:42:25
1953-04-4 - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add anhydrous formic acid 10ml dissolved, add acetic anhydride 50ml, according to the potential titration method (General rule 0701), with perchloric acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml perchloric acid titration solution (0.1mol/L) corresponds to 36.83mg of C17H21NO3. HBr.
Last Update:2022-01-01 13:42:25
1953-04-4 - Category
Authoritative Data Verified Data
anticholinesterase drugs.
Last Update:2022-01-01 13:42:26
1953-04-4 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 13:42:26
1953-04-4 - Galanthamine Hydrobromide Tablets
Authoritative Data Verified Data
This product contains Galanthamine Hydrobromide (C17H21NO3 • HBr) as per Galanthamine (C17H21N03), should be 90.0% ~ 110.0% of the label amount.
trait
This product is a white tablet or film-coated tablet, White after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 10 mg equivalent to Galanthamine Hydrobromide), add 0.5% ammonium molybdate solution, shake to dissolve Galanthamine Hydrobromide, filter, take 1 ml of filtrate and put it in an evaporation dish, water bath on the evaporation, add sulfuric acid 1~2 drops, that is blue-green.
- 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
- relevant substances: take an appropriate amount of the fine powder of this product (about 10 mg of Galanthamine Hydrobromide), put it in a 10ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve Galanthamine Hydrobromide, and dilute it to the scale with mobile phase, shake well, filter, and take the filtrate as the test solution; Take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as a control solution. According to the method of Galanthamine Hydrobromide related substances. 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 (1.0% ) , the sum of each impurity peak area shall not be greater than 2 times (2.0%) the area of the main peak of the control solution. The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
- The content uniformity shall be calculated based on the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- dissolution the dissolution medium is 0931 (4mg) or (8mg) water according to the dissolution and release determination method (General rule method), after 30 minutes, the appropriate amount of the solution was taken, filtered, and then the filtrate was taken as the test solution. In addition, the appropriate amount of Galanthamine Hydrobromide reference was taken, and the precise weighing was performed, dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 50ug of Galanthamine Hydrobromide in μl ml as a reference solution. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should be in accordance with the relevant provisions under the item of tablets (General. 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Using methanol-triethylamine phosphate buffer (take 7ml of triethylamine, 900ml of water, the pH value was adjusted to 0.5 with 6.0 mol/L phosphoric acid solution, and water was added to ML (25:75) as mobile phase. The detection wavelength was 228nm. Take appropriate amounts of Galanthamine Hydrobromide and likelamine hydrobromide, add appropriate amount of mobile phase, shake to dissolve, dilute with mobile phase to make about 1 mg of Galanthamine Hydrobromide and about 0 of likelamine hydrobromide per 1 ml. For the lmg solution, 20ul of the mixed solution is injected into the human liquid chromatograph, and the chromatogram is recorded. The resolution of galantamine peak and likelamine peak shall meet the requirements.
- determination of 10 tablets of this product, respectively, in 25ml(4mg specification) or 50ml( 8mg specification) measuring flask, add appropriate amount of mobile phase to dissolve Galanthamine Hydrobromide and dilute the mobile phase to the scale, after shaking, filtering, the filtrate was taken as the test solution, and 20ul was accurately measured and injected into the human liquid chromatograph, and the chromatogram was recorded, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.2mg of Galanthamine Hydrobromide per 1 ml, which was determined by the same method. The content of each tablet is calculated by peak area according to external standard method, multiplied by 0.7812, and the average content of 10 tablets is obtained.
category
Same as Galanthamine Hydrobromide.
specification
calculated as C17H21NO3 (l)4mg (2)8Mg
storage
light shielding, closed storage.
Last Update:2022-01-01 13:42:27
1953-04-4 - Galanthamine Hydrobromide injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution of Galanthamine Hydrobromide. Galanthamine Hydrobromide (C17H21N03 • HBr) shall be present at 90.0% to 110.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product, according to the Identification Test (1) under the item of Galanthamine Hydrobromide, show the same reaction.
- 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 4.5 to 7.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing 1 mg of Galanthamine Hydrobromide per 1ml as a sample solution; 1ml should be accurately measured and placed in a 100ml volumetric flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. 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 (1.0%), the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution.
- 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; Triethylamine phosphate buffer (take 7ml of triethylamine, add 900ml of water, the pH value was adjusted to 0.5 with 6.0 mol/L phosphoric acid solution, and water was added to ML)-methanol (75:25) as mobile phase, and the detection wavelength was 228mn. Take an appropriate amount of the reference substance of clecklamin hydrobromide and Galanthamine Hydrobromide, add the mobile phase to dissolve and dilute to make about 0ml of clecklamin hydrobromide. The mixed solution of lmg and Galanthamine Hydrobromide (about lmg) shall be injected with 20ul into the liquid chromatograph, and the separation degree of the peak and the main component peak shall meet the requirements.
- determination of precision take the appropriate amount of this product, quantitative dilution with mobile phase made per lml containing about 0.lmg solution, as a test solution, take 20ul injection liquid chromatograph for precise measurement, record chromatogram; Take Galanthamine Hydrobromide reference substance, precision weighing, dissolved and quantitatively diluted with mobile phase 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
Same as Galanthamine Hydrobromide.
specification
(l)lml:lmg (2) lml:2.5mg (3) lml:5mg
storage
light shielding, closed storage.
Last Update:2022-01-01 13:42:28