119302-91-9
Rocuronium bromide
CAS: 119302-91-9
Molecular Formula: C32H53BrN2O4
119302-91-9 - Names and Identifiers
| Name | Rocuronium bromide |
| Synonyms | 119302-91-9 rocuronium bromid Rocuronium bromide (2beta,3alpha,5alpha,16beta,17beta)-17-(acetyloxy)-3-hydroxy-2-(morpholin-4-yl)-16-[1-(prop-2-en-1-yl)pyrrolidinium-1-yl]androstane (2beta,3alpha,5alpha,16beta,17beta)-17-(acetyloxy)-3-hydroxy-2-(morpholin-4-yl)-16-[1-(prop-2-en-1-yl)pyrrolidinium-1-yl]androstane bromide [3-Hydroxy-10,13-dimethyl-2-morpholin-4-yl-16-(1-prop-2-enyl-2,3,4,5-tetrahydropyrrol-1-yl)-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate bromide |
| CAS | 119302-91-9 |
| EINECS | 214-776-5 |
| InChI | InChI=1/C32H53N2O4.BrH/c1-5-14-34(15-6-7-16-34)28-20-26-24-9-8-23-19-29(36)27(33-12-17-37-18-13-33)21-32(23,4)25(24)10-11-31(26,3)30(28)38-22(2)35;/h5,23-30,36H,1,6-21H2,2-4H3;1H/q+1;/p-1/t23?,24-,25?,26?,27+,28+,29?,30+,31+,32+;/m1./s1 |
119302-91-9 - Physico-chemical Properties
| Molecular Formula | C32H53BrN2O4 |
| Solubility | Soluble in water (122 mg/ml at 25 °C), ethanol (122 mg/ml at 25 °C), DMSO (122 mg/ml |
| Storage Condition | 2-8℃ |
| Sensitive | Sensitive to heat |
| MDL | MFCD00867768 |
| Use | A non-depolarizing neuromuscular blocker used in anesthesia to help insert breathing tubes. |
119302-91-9 - Standard
Authoritative Data Verified Data
This product is 1-allyl bromide small [3a,17B- (dihydroxy)-2yH morpholin-1-yl)-5a androsten-16-yl] pyrrolidine europium -17-acetate. The content of C32H53BrN204 shall be between 98.0% and 102.0% calculated as water-free and solvent-free.
Last Update：2024-01-02 23:10:35
119302-91-9 - Trait
Authoritative Data Verified Data
- This product is white-like to yellowish powder with hygroscopicity.
- This product is very soluble in ethanol, soluble in water or methylene chloride, almost insoluble in ether; In 0.lmol/L hydrochloric acid solution is very soluble.
specific rotation
take the right amount of this product, precision weighing, plus O. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 10 mg per 1 ml, which was measured according to law (General 0621). The specific rotation should be 28.5 ° to 32.0 °.
Last Update：2022-01-01 13:35:46
119302-91-9 - Introduction
Rocuronium Bromide is an aminosteroidal non-depolarizing neuromuscular receptor inhibitor or muscle relaxant.
Last Update：2022-10-16 17:12:31
119302-91-9 - Differential diagnosis
Authoritative Data Verified Data
- 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.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- identification of bromide in aqueous solution of this product (1) reaction (General rule 0301).
Last Update：2022-01-01 13:35:46
119302-91-9 - Exam
Authoritative Data Verified Data
alkalinity
take this product O.lg, add water 10ml to dissolve, according to the law to determine (General 0631),pH value should be 8.0~9.5.
clarity and color of solution
take this product O.lg, after dissolving by adding 10ml of water, the solution shall be clear and colorless; In case of color development, it shall not be deeper in comparison with yellow or orange-yellow No. 2 Standard Colorimetric solution (General rule 0901 first method).
Related substances
take this product, precision weighing, add acetonitrile-water (9:1) to dissolve and dilute to make a solution containing about 5mg per 1 ml, as a test solution; take 1 ml of precision, 100ml flask, diluted with acetonitrile-water (9:1) to the scale, shake, as a control solution. According to the chromatographic conditions under the content determination item, l0ul of the control solution and the test solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2.5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the known impurities shall be calculated by the principal component self-control method with correction factor (see table below), other unknown impurities shall be calculated by the main component self-control method without correction factor, and impurity I shall not exceed 0.2%, impurities II and III shall not exceed 0.1%, and impurities IV and V shall not exceed 0.3%, other individual impurities shall not exceed 0.2%, and the total amount of impurities shall not exceed 1.5%. The chromatographic peak before impurity I was not counted.
residual solvent
take about 20% g of this product, precision weighing, top empty bottle, precision plus N,N-dimethylformamide solution 5M l dissolved, sealed, as a test solution; Another methanol, ethanol, diethyl ether, acetone, isopropanol, acetonitrile and two gas methane each appropriate amount, precision weighing, with 20% N,N-dimethylformamide solution quantitative dilution made of methanol in about 300ug per 1 ml, ethanol 500ug, diethyl ether 500uh, acetone 500ug, isopropyl alcohol 500ug, acetonitrile 41ug and dichloromethane 60ug mixed solution, precision volume 5ml, in the top empty bottle, sealed, as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column; The initial column temperature is 45°C, hold for 10 minutes, then raise the temperature to 180°C at a rate of 20°C per minute for 2 minutes; The inlet temperature is 200°C; The detector temperature is 250°C; The equilibrium temperature of the headspace bottle is 90°C, the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. Take the reference solution and the test solution into the headspace respectively, record the chromatogram, calculate the peak area according to the external standard method, methanol, ethanol, ether, acetone, isopropanol, the residual amounts of acetonitrile and dichloromethane shall be in accordance with the regulations.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 4.0%.
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 13:35:47
119302-91-9 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with silica gel as filler; take 0.025mol/L tetramethylammonium hydroxide solution (25% tetramethylammonium hydroxide aqueous solution 9.1ml or 4.53g tetramethylammonium hydroxide pentahydrate, add water 900ml, shake, the pH was adjusted to 7.4 with phosphoric acid and diluted to ML with water-acetonitrile (10:90) as mobile phase; Flow rate was 2.0 mL per minute; Detection wavelength was 210nm. Take the appropriate amount of rocuronium impurity I, II, III, IV, vV and rocuronium reference respectively, and add acetonitrile-water (9:1). Dissolve (when impurity IV is dissolved, dilute hydrochloric acid can be added 1 drop to assist dissolution) and dilute to prepare each 1ml containing rocuronium bromide 1 mg and impurities I, II, III, lV, V 0 respectively. A mixed solution of 1 mg is used as a system-applicable solution. 10u1 was injected into human liquid chromatograph, and the peak order was bromide ion peak, impurity I, II, III, IV, rocuronium bromide and impurity V; the number of theoretical plates shall not be less than 5000 according to the calculation of the rocuronium peak, and the separation degree between the rocuronium peak and the impurity V peak shall be greater than 3.5.
assay
take an appropriate amount of this product, precision weighing, add acetonitrile-water (9:1) to dissolve and quantitatively dilute to prepare a solution containing about 1 mg per 1 ml as a test solution, take 10 u1 accurately, inject human liquid chromatograph, record chromatogram; Take appropriate amount of rocuronium bromide reference substance, and determine with the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:35:48
119302-91-9 - Category
Authoritative Data Verified Data
muscle relaxant.
Last Update：2022-01-01 13:35:48
119302-91-9 - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool place.
Last Update：2022-01-01 13:35:48
119302-91-9 - Esmeron (Rocuronium Bromide Injection)
Authoritative Data Verified Data
This product is a sterile aqueous solution of rocuronium bromide. Rocuronium-containing (C32H53BrN204) shall be between 93.0% and 107.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- 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 5ml of this product and dilute it to 15ml with water for identification reaction of bromide (General rule 0301).
examination
- the pH value should be 3.8 to 4.2 (General 0631).
- clarity and color of the solution this product should be clear and colorless; If the color is colored, it should not be deeper compared with the yellow or orange 2 Standard Colorimetric solution (General Principles 0901 first method).
- an appropriate amount of the related substances (about 5mg of rocuronium bromide) was accurately weighed, placed in a suitable container, and dried at 45 ° C. Or lower with nitrogen gas. Precision Add acetonitrile 2ml, Vortex, ultrasonic, centrifugal, take the supernatant as the test solution; Precision take 1ml, put 100ml flask, with acetonitrile-water (9:1) dilute to the scale, as a control solution; Take the blank solvent (take sodium chloride 30mg, sodium acetate 20mg, sodium bromide 17mg, add water 10ml to dissolve, adjust the pH value to 4.0 with glacial acetic acid) 1ml, according to the same method as the test solution, the solution obtained is used as blank solution; According to the method under the item of rocuronium bromide related substances, if there are impurity peaks in the chromatogram of the test solution, known impurities are calculated by the principal component self-control method with correction factor, and other unknown impurities are calculated by the principal component self-control method without correction factor, impurity I shall not exceed 0.2%, impurity II, III shall not exceed 0.1%, impurity IV shall not exceed 0.3%, impurity V shall not exceed 2.0%, other individual impurities shall not exceed 0.2%, and the total amount of impurities other than impurity V shall not exceed 0.6%. The chromatographic peaks before the blank solution and impurity I were not counted.
- bacterial endotoxin this product, according to the law to check (General 1143), each 1 mg rocuronium bromide containing endotoxin amount should be less than 2.2EU.
- 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 with silica gel as filler; 0.O25mol/L tetramethyl ammonium hydroxide solution (take 25% tetramethyl ammonium hydroxide aqueous solution 9.1ml or take 4.53g tetramethyl ammonium hydroxide pentahydrate, add water 900ml, shake, adjust pH to 7.4 with phosphoric acid and dilute to ML with water-acetonitrile (10:90) as mobile phase; Flow rate 2.0mL per minute; Detection wavelength 210nm. Take the appropriate amount of rocuronium impurity I, II, III, IV, V and rocuronium reference respectively, and add acetonitrile-water (9:1). Dissolve (when impurity IV is dissolved, dilute hydrochloric acid can be added 1 drop to help solubilize) and dilute to prepare 1 mg of rocuronium bromide and 0 each of impurities I, II, III, IV and V per 1 ml. A mixed solution of 1 mg is used as a system-applicable solution. Inject into the liquid chromatograph, the peak order is bromide ion peak, impurity I, II, III, IV, rocuronium bromide and impurity V; the number of theoretical plates shall not be less than 5000 according to the calculation of the rocuronium peak, and the separation degree between the rocuronium peak and the impurity V peak shall be greater than 3.5.
- determination of precision take 5ml of this product, put it in a 50ml measuring flask, dilute to the scale with acetonitrile, shake, as a test solution, take 10 u1, note human liquid chromatograph, record chromatogram; Take appropriate amount of rocuronium bromide reference substance, precisely weigh, dilute with acetonitrile-water (9:1) to about 1 mg solution per 1 ml, as a control solution, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as rocuronium bromide.
specification
(1)2.5ml:25mg (2)5ml:50mg
storage
protected from light and stored at 2-8°C.
Last Update：2022-01-01 13:35:49
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