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96946-42-8

Cisatracurium besilate

CAS: 96946-42-8

Molecular Formula: C53H72N2O12·2C6H5O3S

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96946-42-8 - Names and Identifiers

Name Cisatracurium besilate
Synonyms 96946-42-8
Cisatracurium Besilete
Cisatracurium besilate
Cisatracurium besylate
(1R,2R,1'R,2'R)-2,2'-{pentane-1,5-diylbis[oxy(3-oxopropane-3,1-diyl)]}bis[1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolinium] bisbenzenesulfonate
(1R,1'R,2R,2'R)-2,2'-[1,5-Pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-isoquinolinium dibenzenesulfonate
(1R,2R)-1-(3,4-dimethoxybenzyl)-2-(3-{[5-({3-[(2R,4R)-4-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-3,4-dihydroisoquinolinium-2(1H)-yl]propanoyl}oxy)pentyl]oxy}-3-oxopropyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolinium bisbenzenesulfonate
CAS 96946-42-8
InChI InChI=1/C53H72N2O12.2C6H6O3S/c1-54(34-39(26-36-14-16-44(58-3)46(28-36)60-5)41-32-50(64-9)49(63-8)31-40(41)35-54)21-19-52(56)66-24-12-11-13-25-67-53(57)20-23-55(2)22-18-38-30-48(62-7)51(65-10)33-42(38)43(55)27-37-15-17-45(59-4)47(29-37)61-6;2*7-10(8,9)6-4-2-1-3-5-6/h14-17,28-33,39,43H,11-13,18-27,34-35H2,1-10H3;2*1-5H,(H,7,8,9)/q+2;;/p-2/t39-,43+,54+,55+;;/m0../s1

96946-42-8 - Physico-chemical Properties

Molecular FormulaC53H72N2O12·2C6H5O3S
Storage Condition2-8℃
MDLMFCD00871018
Physical and Chemical PropertiesWhite to light yellow powder
UseCisatracurium Besylate is a non-depolarizing neuromuscular blocker that antagonizes acetylcholine by inhibiting neuromuscular conduction.

96946-42-8 - Standard

Authoritative Data Verified Data

calculated as dried product, the content of C53H72N3012 • 2C5H503S should be 95.0% ~ 102.0%

Last Update：2024-01-02 23:10:35

96946-42-8 - Trait

Authoritative Data Verified Data
  • This product is white or off-white powder; Odorless; With hygroscopicity.
  • This product is soluble in chloroform or ethanol, soluble in acetone, slightly soluble in water.

specific rotation

take this product, precision weighing, plus ethanol dissolution and quantitative dilution of about 10 mg per lml solution, according to the law (General 0621), the specific rotation IS -54 ° to -60 °.

Last Update：2022-01-01 13:34:21

96946-42-8 - Preparation solution concentration reference

 1mg5mg10mg
1 mM0.804 ml4.021 ml8.042 ml
5 mM0.161 ml0.804 ml1.608 ml
10 mM0.08 ml0.402 ml0.804 ml
5 mM0.016 ml0.08 ml0.161 ml
Last Update：2024-01-02 23:10:35

96946-42-8 - Differential diagnosis

Authoritative Data Verified Data
  1. take about 10mg of this product, add 1 ml of dilute hydrochloric acid to dissolve, and add dilute bismuth potassium iodide solution Dropwise to generate yellow precipitate.
  2. the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution in the chromatogram recorded under the item containing the child.
  3. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1164).
Last Update：2022-01-01 13:34:21

96946-42-8 - Exam

Authoritative Data Verified Data

acidity

take 0.lg of this product, add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 3.5~5.0.

clarity and color of solution

take 0.10g of this product and add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method); If it is colored, comparison with yellow No. 2 Standard Colorimetric solution (General rule 0901 first method), not deeper.

sulfate

take 0.50g of this product, add water 30ml to dissolve, check according to law (General rule 0802 ), compared with the standard potassium sulfate solution 2.5ml made of the control solution, not more concentrated (0.05%).

Related substances

take this product, add mobile phase A to dissolve and 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, the mobile phase A was diluted to the scale, and shaken to be used as A control solution; An appropriate amount of A single quaternary ammonium impurity control was taken, and the mobile phase A was added to dissolve and prepare A solution containing about 20ug in 1ml as A positioning control solution. According to the content determination under the chromatographic conditions test. The retention time of the peak of cisatracurium was about 30 minutes; 20 u1 of the reference solution, the control solution and the test solution for positioning were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution,(SS)-isomer (impurity I) and (RS)-isomer (impurity II) the peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the peak area of single quaternary ammonium salt shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution, other single impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution; Except for impurity I and impurity II peaks, the sum of the peak areas of other impurities shall not be greater than 5 times (5.0%) of the main peak area of the control solution.

optical isomer

take this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.3mg per 1ml as the test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake, as a control solution; Take an appropriate amount of atracurium benzenesulfonate control, and dissolve and dilute with mobile phase to make 0. As a control solution, 1 mg of the solution was tested by high performance liquid chromatography (General 0512). Use a chiral chromatographic column (Chmlcel OD-RH column applicable), with 0.05mol/L potassium hexafluorophosphate buffer (take G potassium hexafluorophosphate, add water 3.0 to dissolve, adjust pH to with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 280nm. The reference solution 20u1 is injected into the liquid chromatograph, and the order of peaks is impurity I, impurity II and cisatracurium, and the separation degree between adjacent chromatographic peaks shall meet the requirements. 20ul of the control solution was injected into the liquid chromatograph to adjust the detection sensitivity. The signal-to-noise ratio of the main component peak height should be greater than 10, the chromatogram was recorded. If there is impurity I peak in the chromatogram of the test solution, the peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution. If there is impurity II peak, the peak area shall not be greater than the main peak area of the control solution (1.0%).

loss on drying

take this product, with phosphorus pentoxide as desiccant, at 50°C under reduced pressure drying to constant weight, weight loss should not exceed 2.0% (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 0.2%.

Heavy metals

The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).

Last Update：2022-01-01 13:34:22

96946-42-8 - Content determination

Authoritative Data Verified Data

measured by high performance liquid chromatography (General 0512).

chromatographic conditions and system suitability test

  • silica gel bonded with eighteen alkyl silane as filler; 1.02% potassium dihydrogen phosphate buffer solution (adjusted to pH 3.1 with phosphoric acid)-methanol-acetonitrile (75:5:20) as mobile phase A, the mobile phase B was 1.02% potassium dihydrogen phosphate buffer solution (adjusted to pH 3.1 with phosphoric acid)-methanol-acetonitrile (50:30:20), and the gradient elution was carried out according to the following table; The detection wavelength was 280nm.
  • take an appropriate amount of atracurium benzenesulfonate control, add mobile phase A to dissolve and make it contain 0.lmg solution, 20u1 is injected into the liquid chromatograph, and the peak order is impurity I (relative retention time is about 0.8), impurity II (relative retention time is about 0.9) and cisatracurium, the degree of separation between adjacent chromatographic peaks shall meet the requirements.

assay

take this product, precision weighing, adding mobile phase A to dissolve and quantitatively dilute to make A solution containing about 0.4mg per lml, as A test solution, precision injection liquid chromatograph, the chromatogram was recorded, and the reference substance of benzenesulfonic cis-atracurium was determined by the same method. According to the external standard method to calculate the peak area, that is.

Last Update：2022-01-01 13:34:23

96946-42-8 - Category

Authoritative Data Verified Data

skeletal muscle relaxants.

Last Update：2022-01-01 13:34:23

96946-42-8 - Storage

Authoritative Data Verified Data

It was sealed and stored at 2-8°C.

Last Update：2022-01-01 13:34:23

96946-42-8 - Cisatracurium Besilate for Injection

Authoritative Data Verified Data

This product is a sterile lyophilized product made of benzenesulfonic cisatracurium and suitable auxiliary materials, containing benzenesulfonic cisatracurium, calculated as cisatracurium (C53H12N2012), which should be 90.0% ~ 110.0% of the label amount.

trait

This product is white or off-white loose block or powder.

identification

  1. take this product and use 0.1 mol/L hydrochloric acid solution was prepared to contain 50ug of cisatracurium per 1 ml, and the maximum absorption was determined by UV-visible spectrophotometry (General rule 0401) at 280nm wavelength.
  2. 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

  • acidity take this product, add water to dissolve and make a solution containing 2mg of cisatracurium per lml, and determine it according to law (General rule 0631). The pH value should be 3.0~4.0.
  • the clarity and color of the solution take this product, add water to dissolve and make a solution containing 2mg of cisatracurium per 1 ml, the solution should be clear and colorless; If it is turbid, it shall not be more concentrated than that of turbidity standard liquid No. 1 (General rule 0902 method 1); In case of color development, it shall not be deeper than that of yellow or yellow-green standard colorimetric liquid No. 2 (General rule 0901 method 1).
  • appropriate amount of related substances of this product is dissolved and diluted with mobile phase A to prepare A solution containing about 1 mg of cidraconium as A sample solution per 1 ml, set in A 100ml measuring flask, dilute to the scale with mobile phase A, and shake to serve as A control solution. According to the method for the determination of related substances under the item of benzene sulfonic acid cisatracurium. If there are impurity peaks in the chromatogram of the test solution, the peak areas of impurity I and impurity II shall not be greater than 0.25 times (0.5%) of the main peak area of the control solution, the Peak area of single quaternary ammonium salt shall not be greater than 0.75 times (1.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than 1.5 times (3.0%) of the main peak area of the control solution, except for impurity I, outside the impurity II peak, the sum of each impurity peak area shall not be greater than 4 times (8.0%) the area of the main peak of the control solution.
  • the appropriate amount of optical isomer of this product is taken, and the mobile phase is added to dissolve and dilute to prepare a solution containing 0.3mg of cisatracurium per 1ml as a test solution; according to the method under the item of optical isomer of benzenesulfonic cis-Atracurium, the determination was carried out according to law from the point of "taking 1ml for precise measurement and placing it in a 100ml measuring flask. If there is impurity I peak in the chromatogram of the test solution, the peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution. If there is impurity II peak, the peak area shall not be greater than the main peak area of the control solution (1.0%).
  • the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 3.5%, first method 1).
    • The content uniformity of
  • shall be calculated based on the content of each bottle measured under the content determination item, and shall comply with the regulations (General rule 0941).
  • the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin per 1 mg of cisatracurium should be less than 3.0EU.
  • sterile take this product, add pH 7.0 sterile sodium chloride-peptone buffer to dissolve and dilute the appropriate amount to prepare a solution containing 2mg of cisatracurium per 1 ml, and treat it with membrane filtration method, staphylococcus aureus as a positive control bacteria, according to law inspection (General 1101), should comply with the provisions.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

Take 10 bottles of this product, add water to dissolve, quantitatively dilute with mobile phase A to prepare A solution containing 0.2mg of cisatracurium per 1 ml as A test solution, the average content of 10 bottles was determined according to the method under the item of determining the content of cis-Atracurium in benzene cancer.

category

with benzenesulfonic cis-Atracurium.

specification

Based on C53H12N2012 (l)5mg (2)10mg(3)20Mg

storage

It was sealed and stored at 2-8°C.

Last Update：2022-01-01 13:34:25
96946-42-8
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View History
96946-42-8
1-溴癸烷
1213240-07-3
乙酸正庚酯
3-butenal
18349-11-6
61563-26-6
117811-11-7
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