Ropivacaine hydrochl
Ropivacaine hydrochloride
CAS: 98717-15-8
Molecular Formula: C17H27ClN2O
Ropivacaine hydrochl - Names and Identifiers
| Name | Ropivacaine hydrochloride |
| Synonyms | ROPIVACAINE HCL Ropivacaine hcl (S)-Ropivacaine HCL Ropivacaine hydrochl Ropivacaine hydrochloride ROPIVCACAINE HYDROCHLORIDE (S)-ROPIVACAINE HYDROCHLORIDE (2S)-N-(2,6-dimethylphenyl)-1-propyl-pipecolinamide hydrochloride (2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride (2S)-N-(2,6-dimethylphenyl)-1-propyl-piperidine-2-carboxamide hydrochloride |
| CAS | 98717-15-8 |
| EINECS | 1312995-182-4 |
| InChI | InChI=1/C17H26N2O.ClH/c1-4-11-19-12-6-5-10-15(19)17(20)18-16-13(2)8-7-9-14(16)3;/h7-9,15H,4-6,10-12H2,1-3H3,(H,18,20);1H |
Ropivacaine hydrochl - Physico-chemical Properties
| Molecular Formula | C17H27ClN2O |
| Molar Mass | 310.86 |
| Melting Point | 260-262° |
| Boling Point | 438.2°C at 760 mmHg |
| Specific Rotation(α) | D25 -6.6° (c = 2 in water) |
| Flash Point | 218.8°C |
| Vapor Presure | 4.37E-08mmHg at 25°C |
| Physical and Chemical Properties | Ropivacaine hydrochloride because of white or white-like crystals or crystalline powder; odorless. This product is easily soluble in ethanol, dissolved in water, and almost insoluble in ether. The chemical structure of ropivacaine hydrochloride is similar to mepivacaine and bupivacaine, so the chemical characteristics of ropivacaine hydrochloride are similar to bupivacaine, the pKa of the two are similar, and the plasma protein binding rate is 90%. Ropivacaine hydrochloride is mainly removed by the liver, which produces PPX about 50%, but not by the lungs, heart, etc. Compared with other amide local anesthetics, ropivacaine hydrochloride has the shortest T1/2β, the lowest VDSS and the medium CL. After intravenous injection of ropivacaine hydrochloride and bupivacaine, the CL of the former is significantly higher than that of the latter, and T1/2β is significantly shorter than bupivacaine, suggesting that the toxicity of ropivacaine hydrochloride is weaker than bupivacaine. |
Ropivacaine hydrochl - Standard
Authoritative Data Verified Data
This product is S-(-)-l-propyl-N-(2, 6-dimethylphenyl)-2-piperidinecarboxamide hydrochloride monohydrate or an anhydrous thereof. C17H26N20 • HCl shall not be less than 98.5% calculated as anhydrous and solvent-free.
Last Update：2024-01-02 23:10:35
Ropivacaine hydrochl - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline or crystalline powder; Odorless.
- This product is soluble in ethanol, soluble in water, almost insoluble in ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 20mg per lml, and determine according to law (General rule 0621). The specific rotation is -6.5. To 9.0..
Last Update：2022-01-01 15:06:15
Ropivacaine hydrochl - Differential diagnosis
Authoritative Data Verified Data
- take this product, add 0.01mol/L hydrochloric acid solution to dissolve and dilute to make a solution containing 0401 mg per 1 ml, and measure it by UV-Vis spectrophotometry (general rule), there is a maximum absorption at a wavelength of 262nm and a shoulder at a wavelength of 270Nm.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:06:15
Ropivacaine hydrochl - Exam
Authoritative Data Verified Data
acidity
take 0.5g of this product, add 50ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.0~6.0.
clarity and color of solution
take 0.2g of this product, Add 10ml of water to dissolve, the solution should be clear and colorless.
Related substances
take an appropriate amount of this product, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing 2.5mg per 1ml as a test solution; Take 1ml for precision measurement, put it in a 100ml measuring flask, dilute it to scale with mobile phase, shake well, take 1ml with precision, put it in a 10ml measuring flask, dilute it to scale with mobile phase, shake well, use it as control solution; Take 2 ,6-dimethyl aniline control appropriate amount, precision weighing, plus mobile phase dissolution and quantitative dilution made per 1ml containing 0.lug solution, as a control solution. According to the test of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as the filler; 1.3ml of acetonitrile-phosphate buffer solution (1 mol/L sodium dihydrogen phosphate solution, 0.5 ml of 32.5 mol/L disodium hydrogen phosphate solution was added with water to 8.0 ml, and the pH value was adjusted to (50:50) as mobile phase. The detection wavelength was 240nm. Take the appropriate amount of bupivacaine hydrochloride and ropivacaine hydrochloride, add mobile phase to dissolve and dilute to make mixed solution containing 10ug per lml respectively, and take 20ul to inject human liquid chromatograph, the resolution of bupivacaine peak and ropivacaine peak should be more than 6.0, and the number of theoretical plates should not be less than 2000 according to ropivacaine peak. The sample solution, the control solution and the reference solution were respectively injected with 20 u1, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there is a peak consistent with the retention time of bupivacaine in the chromatogram of the test solution, the peak area shall not be greater than 2 times (0.2%) of the main peak area of the control solution, chromatographic peaks with the same retention time of 6-dimethylaniline shall not exceed 0.001% based on the peak area calculated by external standard method, and the peak area of other individual impurities shall not be greater than 1.5 of the main peak area of the control solution ↑ (0.15%)» impurities should not exceed 0.5%.
dextroisomerism
take an appropriate amount of this product, add the mobile phase to dissolve and quantitatively dilute to make 0.1 mg of the solution was used as a test solution; An appropriate amount was quantitatively diluted with a mobile phase to prepare a solution containing 1 μg per 1 ml as a control solution. Acid glycoprotein column (AGP, 0512 X 4.0mm, 5um or performance equivalent column) according to high performance liquid chromatography (General rule 1) test; with isopropyl-phosphate buffer (take potassium dihydrogen phosphate 2.72g, add water 800ml dissolved, with 0. The pH value of 1 mol/L sodium hydroxide solution was adjusted to 7.1 and diluted to 1000ml with water (10:90) as mobile phase. The detection wavelength was 210nm. Take the right amount of ropivacaine hydrochloride and the right amount of ropivacaine hydrochloride, and add the mobile phase to dissolve and dilute to prepare the mixed solution containing 0.05mg per 1 mL respectively. Take 20u1 and inject the liquid chromatograph, the resolution of right-handed ropivacaine hydrochloride peak and ropivacaine hydrochloride peak should meet the requirements. The sample solution and the control solution were respectively injected with 20 u1 for human liquid chromatograph. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of ropivacaine hydrochloride, the peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
residual solvent
take 0.5g of this product, precision weighing, in the top empty bottle, Precision Add dimethyl sulfoxide 5ml to dissolve, sealed, as a test solution; Another precision weighing ethyl alcohol, acetone, isopropyl alcohol, three gas methane, toluene and N, N-dimethylformamide each appropriate amount, dissolved and diluted with dimethyl sulfoxide, made in per 1 ml containing 500ug of fermentation, acetone 500ug, isopropyl fermentation 500ug, A mixed solution of 6ug of trimethylchloroalkane, 8ug of toluene and 88ug of N, N-dimethylformamide, 5ml of which was precisely weighed, placed in a headspace bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as the stationary liquid is the column; The initial temperature is 40°C, maintain for 10 minutes, at a rate of 10°C per minute to 240°C, maintain for 20 minutes; Injection port temperature is 220°C; Detector temperature is 280°C; Headspace bottle equilibrium temperature is 110°C, the equilibration time was 20 minutes. Take the reference solution into the headspace, and the resolution of each chromatographic peak shall meet the requirements. Then take the sample solution and the reference solution into the headspace respectively, record the chromatogram, calculate the peak area according to the external standard method, and extract, acetone, isopropanol, methane, toluene and N, the residual amount of N-dimethylformamide shall be in accordance with the regulations.
moisture
take this product, according to the moisture determination method (General rule 0832 first method 1), ropivacaine hydrochloride monohydrate water content should be 5.0% ~ 6.0%; ropivacaine hydrochloride anhydrous containing water should not exceed 2.0%.
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 ignition residue shall be inspected according to law (General Principles 0821 second law) and shall not contain more than 10 parts per million of heavy metals.
Last Update：2022-01-01 15:06:16
Ropivacaine hydrochl - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add water 10ml and ethanol 20ml dissolved, add phenolphthalein indicator solution 2 drops, with sodium hydroxide titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 31.09mg of C17H26N20.HCl.
Last Update：2022-01-01 15:06:17
Ropivacaine hydrochl - Category
Authoritative Data Verified Data
local anesthetic.
Last Update：2022-01-01 15:06:17
Ropivacaine hydrochl - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:06:17
Ropivacaine hydrochl - Romethaine hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of ropivacaine hydrochloride. Ropivacaine hydrochloride (C17H26N20 • HCl) should be included between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless 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 an appropriate amount of this product and use O.Olmol/L hydrochloric acid solution diluted into about 0401 mg ropivacaine hydrochloride solution per 1 ml, according to UV-visible spectrophotometry (general) determination, there is a maximum absorption at a wavelength of 262nm and a shoulder at a wavelength of 270Nm.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- relevant substances: take an appropriate amount of this product and dilute it with mobile phase to prepare a solution containing 2.5mg of ropivacaine hydrochloride per 1ml as a test solution; Take 1ml for precision measurement, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution; Take an appropriate amount of 2, 6-dimethylaniline reference, and weigh it precisely, the mobile phase was added for dissolution and quantitative dilution to prepare a solution containing 0.lug solution, as a control solution. According to ropivacaine hydrochloride related substances determination method. In the chromatogram of the test solution, if there is a chromatographic peak consistent with the retention time of 2, 6-dimethylaniline, the peak area shall be calculated according to the external standard method, and 0.01% of the labeled amount of ropivacaine hydrochloride shall not be passed, the Peak area of other individual impurities shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; The total amount of impurities shall not exceed 1.0%.
- d-isomer: Take appropriate amount of this product and dilute it with mobile phase to prepare ropivacaine hydrochloride O in each lml. 1 mg of the solution was used as a test solution; 1ml was accurately weighed, placed in a 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of ropivacaine hydrochloride dextroisomer. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of ropivacaine hydrochloride, the peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
- The osmolality shall be 0632 ~ 320mOsmol/kg when the product is taken for inspection according to law (General Rule 260).
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg ropivacaine hydrochloride containing endotoxin amount should be less than 0.05EU.
- 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; Acetonitrile-phosphate buffer (1 mol/L sodium dihydrogen phosphate solution 1.3ml,0.5mol/L disodium hydrogen phosphate solution was added to 32.5ml, and the pH value was adjusted to 8.0 (50:50) as mobile phase. The detection wavelength was 240mn. Take appropriate amount of bupivacaine hydrochloride and ropivacaine hydrochloride, add mobile phase to dissolve and dilute to make mixed solution containing each lOug in each lml, take 20u1 injection human liquid chromatograph, record chromatogram, the resolution of bupivacaine peak and ropivacaine peak should be more than 6.0, and the number of theoretical plates should not be less than 2000 according to ropivacaine peak.
- determination precision: take an appropriate amount of this product, quantitatively dilute it with mobile phase to prepare a solution containing 0.6mg of ropivacaine hydrochloride per 1 ml, shake well, and use it as a test solution, 20 u1 was accurately measured, and human liquid chromatography was injected to record the chromatogram. Another reference substance of ropivacaine hydrochloride was taken, the mobile phase was added to dissolve and quantitatively dilute to make a solution containing 0.6mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with ropivacaine hydrochloride.
specification
(l)10ml:75mg (2)10ml:lOOmg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:06:18
Ropivacaine hydrochl - Ropivacaine Hydrochloride for Injection
Authoritative Data Verified Data
This product is a sterile lyophilized product of ropivacaine hydrochloride. Ropivacaine hydrochloride (C17H26N20 • HC1) shall be present at 95.0% to 105.0% of the labeled amount.
trait
This product is white or off-white loose block or powder.
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 an appropriate amount of this product and add O.Olmol/L hydrochloric acid solution is dissolved and diluted to prepare a solution containing about 0401 mg ropivacaine hydrochloride per 1 ml, which is determined by UV-Vis spectrophotometry (general rule), there is a maximum absorption at a wavelength of 262mn and a shoulder at a wavelength of 270Nm.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- acidity the pH value of the solution under the items of clarity and color is determined according to law (General 0631), and the pH value should be 4.0-6.0.
- the clarity and color of the solution take 5 bottles of this product, after each bottle is dissolved with 10ml of water, the solution should be clear and colorless; If it is turbid, and 1 turbidity standard solution (General rule 0902 first method) comparison, not more concentrated; If the color, with the yellow No. 1 Standard Colorimetric liquid (General Principles 0901 The first method), not deeper.
- the contents under the item of difference in loading amount of related substances shall be mixed evenly and weighed accurately and the appropriate amount shall be taken, add mobile phase to dissolve and quantitatively dilute to prepare a solution containing 2.5mg ropivacaine hydrochloride per 1ml as a 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 2, 6-dimethylaniline control, precision weighing, dissolved and quantitatively diluted with mobile phase to make 0 per 1ml. lug solution, as a control solution. According to ropivacaine hydrochloride related substances determination method. In the chromatogram of the test solution, if there is a chromatographic peak consistent with the retention time of 2, 6-dimethylaniline, the peak area shall be calculated according to the external standard method, and 0.01% of the labeled amount of ropivacaine hydrochloride shall not be passed, the Peak area of other individual impurities shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution; The total amount of impurities shall not exceed 1.0%.
- the contents under the item of difference in loading amount of D-isomer were mixed uniformly, weighed and taken in an appropriate amount, dissolved and diluted with mobile phase to make ropivacaine hydrochloride O per 1ml. 1 mg of the solution was used as a test solution; 1ml was accurately weighed, placed in a 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of ropivacaine hydrochloride dextroisomer. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of ropivacaine hydrochloride, the peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.0% first method).
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg ropivacaine hydrochloride containing endotoxin amount should be less than 0.05EU.
- 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; Acetonitrile-phosphate buffer (1 mol/L sodium dihydrogen phosphate solution 1.3ml, 0.5mol/L disodium hydrogen phosphate solution 32.5ml, add water to 10% ml, adjust the pH value to 8.0 with phosphoric acid)(50:50) as mobile phase; The detection wavelength is 240mn. Take the appropriate amount of bupivacaine hydrochloride and ropivacaine hydrochloride, add the mobile phase to dissolve and dilute the mixed solution containing 10ug per lml, and inject 20u1 into the liquid chromatograph, the resolution of bupivacaine peak and ropivacaine peak should be more than 6.0, and the number of theoretical plates should not be less than 2000 according to ropivacaine peak.
- the content under the item of difference in loading amount is measured, mixed evenly, and the appropriate amount is accurately weighed, add the mobile phase to dissolve and quantitatively dilute the solution containing 0.6mg ropivacaine hydrochloride in each lml, shake well, as a test solution, take 20 u1 with precision, and inject human liquid chromatograph, the chromatogram was recorded; Another ropivacaine hydrochloride reference substance was precision weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing 0.6mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with ropivacaine hydrochloride.
specification
75mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:06:19
