SCOPOLAMINE N-BUTYL BROMIDE - Names and Identifiers
Name | (-)scopolamine N-butyl bromide
|
Synonyms | BUTYLMIN HYOSCINE BUTYLBROMIDE Hyoscine butylbromide Hyoscinen butylbromide hyoscine butylobromide Hyoscine-N-Butyl Bromide HYOSCINE N-BUTYL BROMIDE Scopolamine Butylbromide N-butylhyoscinium bromide SCOPOLAMINI BUTYLBROMIDUM SCOPOLAMINE N-BUTYL BROMIDE (-)-N-BUTYLSCOPOLAMIDE BROMIDE (-)-N-BUTYLSCOPOLAMINE BROMIDE (-)scopolamine N-butyl bromide (-)-SCOPOLAMINE N-BUTYL BROMIDE (1S,2R,4S,5S)-9-butyl-7-[(3-hydroxy-2-phenylpropanoyl)oxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0~2,4~]nonane bromide (1S,2R,4S,5S)-9-butyl-7-{[(2S)-3-hydroxy-2-phenylpropanoyl]oxy}-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0~2,4~]nonane bromide
|
CAS | 149-64-4
|
EINECS | 205-744-1 |
InChI | InChI=1/C21H30NO4.BrH/c1-3-4-10-22(2)17-11-15(12-18(22)20-19(17)26-20)25-21(24)16(13-23)14-8-6-5-7-9-14;/h5-9,15-20,23H,3-4,10-13H2,1-2H3;1H/q+1;/p-1/t15?,16-,17+,18+,19-,20+,22?;/m1./s1 |
SCOPOLAMINE N-BUTYL BROMIDE - Physico-chemical Properties
Molecular Formula | C21H30BrNO4
|
Molar Mass | 440.37 |
Melting Point | 142-1440C |
Specific Rotation(α) | D20 -20.8° (c = 3 in water) |
Solubility | H2O: 50mg/mL |
Appearance | powder |
Color | white |
Storage Condition | 2-8°C |
Physical and Chemical Properties | White crystalline powder, soluble in methanol, ethanol, DMSO and other organic solvents, from the Solanaceae plant White Datura dry flowers. |
SCOPOLAMINE N-BUTYL BROMIDE - Risk and Safety
Hazard Symbols | Xn - Harmful
|
Risk Codes | 22 - Harmful if swallowed
|
WGK Germany | 3 |
RTECS | YM3500000 |
Toxicity | LD50 in mice (mg/kg): 15.6 i.v.; 74 i.p.; 570 s.c.; 3000 orally (Stockhaus, Wick) |
SCOPOLAMINE N-BUTYL BROMIDE - Standard
Authoritative Data Verified Data
This product is 6B,7B-epoxy-3a-hydroxy -8-butyl-1aH,5aH-tropane (-)-tropic acid ester. Calculated as dry product, including C21H30)BrN04 shall not be less than 99.0%.
Last Update:2024-01-02 23:10:35
SCOPOLAMINE N-BUTYL BROMIDE - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless or almost odorless.
- This product is soluble in water or chloroform, and slightly soluble in ethanol.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make about O in each lml. lg of the solution, determined according to law (General rule 0621), the specific rotation is -18 ° to -20 °.
Last Update:2022-01-01 11:30:31
SCOPOLAMINE N-BUTYL BROMIDE - Differential diagnosis
Authoritative Data Verified Data
- take this product, add 0.0lmol/L hydrochloric acid solution to dissolve and dilute to prepare a solution containing lmg per lml, and measure it by UV-Vis spectrophotometry (General 0401), there is maximum absorption at the wavelengths of 252nm, 257nm and 264mn.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 21).
- This product is the identification of tropane alkaloids reaction (General Principles 0301).
- the product of the aqueous solution of the identification of bromide reaction (General 0301).
Last Update:2022-01-01 11:30:31
SCOPOLAMINE N-BUTYL BROMIDE - Exam
Authoritative Data Verified Data
acidity
take this product • Add water to make a solution containing O.lg per lml, and measure it according to law (through 0631). The pH value should be 5.5~6.5.
clarity of the solution
take 0.5g of this product, add 15ml of water to dissolve, the solution should be clear.
Related substances
take this product, precision weighing, plus flooding phase dissolution and made of each 1ml containing about 2.5mg of solution, as a test solution; Precision take the right amount, dilute with water to make a solution containing about 20 nets per 1ml, as the solution; Take the appropriate amount of scopolamine hydrobromide control, precision weighing, plus mobile phase dissolution and period to about 0 per 1ml. Olmg solution, as a control solution; Take the test solution 1ml, put in 10ml measuring flask, with the control solution diluted to the scale, shake, as the system applicable solution. Silica gel bonded with eighteen alkyl silanes was used as the filler, as determined by HPLC (General 0512); 0.004% phosphoric acid solution-ethyl guess (50:50). The prepared 0.008mol/L sodium dodecyl sulfate solution was used as mobile phase, and the detection wavelength was 210mn. 10ul of the applicable solution of the system is injected into the human liquid chromatograph, and the number of theoretical plates is not less than 3000 according to the calculation of scopolamine butylbromide peak. The separation degree of scopolamine butylbromide peak and scopolamine hydrobromide peak shall meet the requirements. Take 10ul of each of the above three solutions with precision, inject human liquid chromatography respectively, and record the chromatogram to 2 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of scopolamine hydrobromide peak, the peak area shall be calculated according to the external standard method, and shall not exceed 0.4%, each impurity peak (the bromide ion peak near the solvent peak is removed) the sum of the areas shall not be greater than the area of the main peak of the control solution (0.8%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 2.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update:2022-01-01 11:30:32
SCOPOLAMINE N-BUTYL BROMIDE - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add water 50ml to make the solution, according to the potential titration method (General 0701), using silver electrode, with silver nitrate titration method (0.lmol/L) titration. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 44.04mg of c21h30brno4.
Last Update:2022-01-01 11:30:32
SCOPOLAMINE N-BUTYL BROMIDE - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:30:33
SCOPOLAMINE N-BUTYL BROMIDE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 11:30:33
SCOPOLAMINE N-BUTYL BROMIDE - Scopolamine Butylbromide Itnjection
Authoritative Data Verified Data
This product is a sterile aqueous solution of scopolamine butylbromide. Scopolamine containing butyl bromide (C21H30BrN04) shall be between 93.0% and 107.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- taking an appropriate amount of this product, the same results were shown according to the tests of item (1) and (4) under the item of scopolamine butylbromide.
- take 0.5 of this product, put it on a water bath and evaporate it to dryness. Identify the residual submergence of tropane alkaloids (General rule 0301).
examination
- the pH value should be 3.7 to 5.5 (General 0631).
- precise measurement of related substances: take this product and quantitatively dilute it with water to make a solution containing about 2mg of scopolamine butylbromide per 1 ml as the test solution, dilute with water to make a solution containing about 40ug per 1 ml, as a control solution; Take an appropriate amount of scopolamine hydrobromide reference substance, weigh it precisely, add water to dissolve and make a solution containing about 20ug per 1 ml, as a control solution. According to the chromatographic conditions under the content determination item, the above three kinds of solutions are accurately weighed 10ug, respectively injected into the human liquid chromatograph, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there is a peak in the chromatogram of the test solution which is consistent with the retention time of scopolamine hydrobromide peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount of scopolamine butylbromide shall not be allowed, the sum of the area of each impurity peak (removing the bromide ion peak near the solvent peak) shall not be greater than 1 time (4.0%) of the area of the main peak of the control solution.
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg of scopolamine butylbromide in the amount of endotoxin should be less than 7.5EU.
- sterile take this product, by membrane filtration method, with 0.1% sterile peptone water rinse (not less than 100ml per membrane), with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101), should comply with the provisions.
- 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; 0.004% mol/L sodium dodecyl sulfate solution prepared by 0.008 phosphoric acid solution-acetonitrile (50:50) as mobile phase, the detection wavelength was 210nm. Take the appropriate amount of scopolamine butylbromide and scopolamine hydrobromide, add the mobile phase to dissolve and make the solution containing 0.4mg and 20ug per 1 mL respectively. Take 20u1 and inject human liquid chromatograph, record the chromatogram, the number of theoretical plates shall not be less than 3000 according to the calculation of scopolamine butylbromide peak. The separation degree between scopolamine butylbromide peak and scopolamine hydrobromide peak shall meet the requirements.
- determination of precision quantity take appropriate amount of this product, quantitative dilution with mobile phase to make a solution containing about 0.4mg per lml, precision quantity of 20pl injection of human liquid chromatography, record chromatogram; another reference substance of scopolamine butylbromide was accurately weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing about 0.4mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
scopolamine isobutylbromide.
specification
lml : 20mg
storage
light shielding, closed storage.
Last Update:2022-01-01 11:30:34
SCOPOLAMINE N-BUTYL BROMIDE - Scopolamine Butylbromide Capsules
Authoritative Data Verified Data
This product contains scopolamine butylbromide (C21H30BrNO4) should be labeled the amount of 90.0% to 110.0%.
identification
- take an appropriate amount of the content of this product (about 50mg of scopolamine butylbromide), add chloroform 20ml, shake to dissolve, filter, and evaporate the filtrate on a water bath, 50ml of a 0.01mol/L hydrochloric acid solution was added to dissolve, and the absorption maxima at wavelengths of 0401 nm, NM and NM were measured by ultraviolet-visible spectrophotometry (general).
- take an appropriate amount of the content of this product (about 10mg of scopolamine butylbromide), add 5ml of chloroform, shake to dissolve, quickly filter, and evaporate the filtrate on a water bath, identification reaction of the residues of the alkaloids (General 0301).
- the product of the aqueous solution of the identification of bromide reaction (General 0301).
examination
- for related substances, appropriate amount of fine powder (about 20mg of scopolamine butylbromide) was added into a 10ml measuring flask, and the mixture was dissolved with mobile phase and diluted to the scale, take the filtrate as the test solution; Take 1ml of the test solution accurately, put it in a 50ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as the control solution; another scopolamine hydrobromide reference substance was carefully weighed and dissolved by adding mobile phase to make a solution containing about 20ug per 1ml as a reference solution. According to the chromatographic conditions under the content determination item, 10 u1 of each of the above three solutions are accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there is a peak in the chromatogram of the test solution which is consistent with the retention time of scopolamine hydrobromide peak, the peak area shall be calculated according to the external standard method, and 1.0% of the labeled amount of scopolamine butylbromide shall not be allowed, the sum of the area of each impurity peak (removing the bromide ion peak near the solvent peak) shall not be greater than 2 times (4.0%) the area of the main peak of the control solution.
- 1 capsule of this product was added into a 25ml measuring flask, the capsule shell was washed with water, the lotion was added into the measuring flask, about 15ml of water, and fully shaken, scopolamine butylbromide was dissolved, diluted to scale with water, shaken and allowed to stand, and the supernatant was accurately measured as a test solution. Determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- others should comply with the relevant provisions under the capsule (General 0103).
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; 0.004% mol/L sodium dodecyl sulfate solution prepared by 0.008 phosphoric acid solution-acetonitrile (50:50) as mobile phase, the detection wavelength was 2 l0nm. Take the appropriate amount of scopolamine butylbromide and scopolamine hydrobromide, add the mobile phase to dissolve and make the solution containing 0.4mg and 20ug per mL respectively. Take 2u1 and inject it into the liquid chromatograph, record the chromatogram, the number of theoretical plates shall not be less than 3000 according to the calculation of scopolamine butylbromide peak. The separation degree between scopolamine butylbromide peak and scopolamine hydrobromide peak shall meet the requirements.
- determination of the content of this product 20 capsules, precision weighing, fine grinding, mixing, precision weighing an appropriate amount (equivalent to 20mg of scopolamine butylbromide), add mobile phase to dissolve scopolamine butylbromide and quantitatively dilute to make a solution containing about 0.4mg per 1 ml, filter, take a precise amount of filtrate and inject 20ul into human liquid chromatograph, record chromatogram; another reference substance of scopolamine butylbromide was carefully weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing about 0.4mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
scopolamine isobutylbromide.
specification
10mg
storage
light shielding, sealed storage.
Last Update:2022-01-01 11:30:35