AMBROXOL HYDROCHLORIDE
AMBROXOL HYDROCHLORIDE
CAS: 15942-05-9;23828-92-4
Molecular Formula: C13H19Br2ClN2O
AMBROXOL HYDROCHLORIDE - Names and Identifiers
| Name | AMBROXOL HYDROCHLORIDE |
| Synonyms | MUCOSOLVAN AMBROXOL HCL AMBROXOLHYDROCLORIDE AMBROXOL HYDROCHLORIDE N-(2-amino-3,5-dibromobenzyl)-4-hydroxycyclohexanaminium TRANS-4-((2-AMINO-3,5-DIBROMOBENZYL)AMINO)CYCLOHEXANOL, HCL 4-[(2-amino-3,5-dibromo-benzyl)amino]cyclohexanol hydrochloride trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride 2-AMINO-3,5-DIBROMO-N-[TRANS-4-HYDROXYCYCLOHEXYL]BENZYLAMINE HYDROCHLORIDE trans-4-[[(2-amino-3,5-dibromo-phenyl)methyl]amino]-cyclohexanol hydrochloride TRANS-4-[[(2-AMINO-3,5-DIBROMOPHENYL)METHYL]AMINO]CYCLOHEXANOL MONOHYDROCHLORIDE |
| CAS | 15942-05-9 23828-92-4 |
| EINECS | 245-899-2 |
| InChI | InChI=1/C13H18Br2N2O.ClH/c14-9-5-8(13(16)12(15)6-9)7-17-10-1-3-11(18)4-2-10;/h5-6,10-11,17-18H,1-4,7,16H2;1H/t10-,11- |
AMBROXOL HYDROCHLORIDE - Physico-chemical Properties
| Molecular Formula | C13H19Br2ClN2O |
| Molar Mass | 414.56 |
| Melting Point | 235 - 240°C |
| Boling Point | 492.6°C at 760 mmHg |
| Flash Point | 251.7°C |
| Vapor Presure | 1.61E-10mmHg at 25°C |
| Appearance | White to pale yellow crystalline powder |
| Storage Condition | 2-8°C |
| MDL | MFCD00078932 |
| Physical and Chemical Properties | Storage Conditions: 2-8 ℃ WGK Germany:3 RTECS:GV8423000 |
| Use | Cough medicine |
AMBROXOL HYDROCHLORIDE - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 22 - Harmful if swallowed |
| Safety Description | 36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | GV8423000 |
AMBROXOL HYDROCHLORIDE - Standard
Authoritative Data Verified Data
This product is trans-4-[(2-amino -3, 5-dibromobenzyl) amino] cyclohexanol hydrochloride. The content of C13H18Br2N20 • HC1 shall not be less than 99.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
AMBROXOL HYDROCHLORIDE - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystalline powder; Almost odorless.
- This product is dissolved in methanol, slightly soluble in water, slightly soluble in ethanol.
absorption coefficient
take the right amount of this product, precision weighing, plus O.Olmol/L hydrochloric acid solution is dissolved and quantitatively diluted to prepare a solution containing about 25ug per 1 ml, and the absorbance is measured at the wavelength of 244mn by ultraviolet-visible spectrophotometry (General rule 0401), the absorption coefficient was 233-247.
Last Update：2022-01-01 15:33:12
AMBROXOL HYDROCHLORIDE - Introduction
Ambroxol HCl is an effective neurogenic sodium channel inhibitor, inhibiting sodium ion current against TTX, phase block, IC50 is 22.5 μM, inhibiting sodium ion current sensitive to TTX, IC50 is 100 μM. Phase 3.
Last Update：2022-10-16 17:14:12
AMBROXOL HYDROCHLORIDE - 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.
- take this product, add O. The Olmol/L hydrochloric acid solution was prepared as a solution containing about 25ug per 1 ml, and had a maximum absorption at wavelengths of 244nm and 308nm as determined by UV-visible spectrophotometry (General 0401).
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1102).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:33:12
AMBROXOL HYDROCHLORIDE - Exam
Authoritative Data Verified Data
acidity
take 0.20g of this product, add 20ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 4.5~6.0.
clarity and color of methanol solution
take 0.50g of this product and add 0902 of methanol to dissolve the solution. 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 first method); in case of color development, it shall not be deeper in comparison with the yellow No. 3 Standard Colorimetric solution (General rules 0901 first method).
Related substances
take this product, add mobile phase to dissolve and dilute to make 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 chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than 0.3 times (0.3%) of the main peak area of the control solution.
residual solvent
take about 0.3g of this product, weigh it accurately, put it in a 10ml headspace bottle, add the internal standard solution accurately (take the right amount of methyl ethyl ketone, add 80% dimethyl sulfoxide solution to make a solution containing mg of butanone per 1 ml) 3ml to dissolve, seal, and use as a test solution; Take methanol, anhydrous ethanol, acetone, dichloromethane and chloroform in appropriate amounts, precision weighing, dissolving and quantitatively diluting with human internal standard solution to prepare solutions containing 0.3mg of methanol, 0.5mg of ethanol, 0.5mg of acetone, 0.06mg of dichloromethane and 0.006mg of chloroform per 1 mL respectively, take 3ml of precision, put in 10ml headspace bottle, sealed, as a reference solution. 5% phenyl -0861 methyl polysiloxane (or polar phase
) as tested by the method for determination of residual solvents (general section 95%, second method).
Near) is a stationary liquid; The column temperature is 40°C, maintained for 5 minutes, then the temperature is raised to 120°C at a rate of 10°C per minute, maintained for 5 minutes; The injection temperature is 150°C; the detector temperature was 220°C; The headspace bottle equilibration temperature was 85°C; And the equilibration time was 25 minutes. The test solution and the reference solution are injected in Headspace respectively, and the chromatogram is recorded. The residual amount of methanol, ethanol, acetone, methane and chloroform shall be calculated by the peak area according to the internal standard method.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (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 0.1%.
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).
arsenic salt
take this product l.Og, add water 10ml and hydrochloric acid 15ml to dissolve, check according to law (General Principles 0822 The first law), should comply with the provisions (0.0002%).
Last Update：2022-01-01 15:33:13
AMBROXOL HYDROCHLORIDE - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with a Eighteen alkyl silane as a filler; O.Olmol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 248mn. Take about 5mg of this product, add 0.2ml of methanol to dissolve, add 40ul of formaldehyde solution (1-100), shake well, place it in 60°C water bath for 5 minutes, and blow dry with nitrogen. The residue was dissolved in 5ml of water, diluted to 20ml with mobile phase, shaken, and 20u1 was injected into the liquid chromatograph. Ambroxol peak and impurity I Peak (relative retention time is about 0.8) the degree of separation between should be greater than 4.0.
assay
take an appropriate amount of this product, precision weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 30ug per lml, as a test solution, take 20 u1 for precision, injection of human liquid chromatography, record chromatogram; Another Ambroxol hydrochloride reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:33:14
AMBROXOL HYDROCHLORIDE - Category
Authoritative Data Verified Data
expectorant.
Last Update：2022-01-01 15:33:14
AMBROXOL HYDROCHLORIDE - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:33:14
AMBROXOL HYDROCHLORIDE - Ambroxol hydrochloride □ oral solution
Authoritative Data Verified Data
This product contains Ambroxol hydrochloride (C13H18Br2N20 • HCl) should be 95.0% to 105.0% of the label.
trait
This product is a 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 an appropriate amount of this product and use 0.1 mol/L hydrochloric acid solution was diluted to prepare a solution containing about 30ug of Ambroxol hydrochloride per 1 ml, and the maximum absorption was determined by UV-visible spectrophotometry (General 0401) at a wavelength of 308nm.
examination
- relative density the relative density of this product (General 0601) shall not exceed 1.200 (sugar type).
- the pH value should be 2.5 to 6.0 (General 0631).
- clarity and color this product 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.
- others should comply with the relevant provisions under the item of oral solution (General rule 0123).
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; 0.01mol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) the detection wavelength was 248nm. Take about 5mg of Ambroxol hydrochloride, add 0.2ml of methanol to dissolve, add formaldehyde solution (1-100)40 u1, shake, place 60°C water bath for 5 minutes, dry with nitrogen. The residue was dissolved with 5ml of water, diluted to 20ml with mobile phase, and then injected with 20u1 into the liquid chromatograph. The resolution between Ambroxol peak and impurity I Peak (relative retention time is about 0.8) should be greater than 4.0.
- determination precision: take an appropriate amount of this product (viscous liquid is measured by internal volume pipette), and quantitatively dilute it with mobile phase to prepare a solution containing about 30ug of Ambroxol hydrochloride per 1 ml, which is used as a test solution, take 20 u1 accurately, inject human liquid chromatograph, record chromatogram; Take appropriate amount of Ambroxol hydrochloride reference substance, weigh accurately, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 30ug per lml, same method determination. According to the external standard method to calculate the peak area, that is.
category
Same as Ambroxol hydrochloride.
specification
(l)5ml:15mg (2) 10ml:30mg ( 3 ) 60ml:180mg (4) 100ml:0.3g (5)100ml:0.6g
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:33:15
AMBROXOL HYDROCHLORIDE - Ambroxol HydrochlorideTablets
Authoritative Data Verified Data
This product contains Ambroxol hydrochloride (C13H18Br2N20 • HCl) should be 95.0% ~ 105.0% of the label.
trait
This product is white or off-white.
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.
- the solution under the item of dissolution was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of 244mn and 308nm.
examination
- relevant substances: take an appropriate amount of fine powder of this product, add mobile phase to dissolve and dilute to prepare a solution containing 1 mg of Ambroxol hydrochloride per 1ml, filter, and take the continued filtrate as the test solution; take 1ml of precision, 100ml flask, diluted with mobile phase to scale, shake, as a control solution. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- dissolution dissolution of this product, according to the dissolution and release determination method (General 0931 second method), hydrochloric acid solution (9-1000)900ml as the dissolution medium, the rotation speed is 75 rpm, operate in accordance with the law, after 30 minutes, take an appropriate amount of the solution to filter, take a precise amount of filtrate, continue to take 5ml, put it in a 10ml measuring flask, dilute to the scale with dissolution medium, shake well, measure absorbance at the wavelength of 244mn according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of Ambroxol hydrochloride reference, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 15ug per 1 ml, and the dissolution amount of each tablet was calculated by the same method. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler; O.Olmol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 248mn. Take about 5mg of Ambroxol hydrochloride, add 0.2ml of methanol to dissolve, add formaldehyde solution (1-100)40 u1, shake, place 60°C water bath for 5 minutes, dry with nitrogen. 5ml of residual water was added to dissolve, and the solution was diluted to 20ml with mobile phase, and 20u1 was injected into the liquid chromatograph. The resolution between Ambroxol peak and impurity I Peak (relative retention time is about 0.8) should be greater than 4.0.
- determination of 20 tablets of this product, precision weighing, fine, precision weighing to take appropriate amount, plus mobile phase dissolution and quantitative dilution to make a solution containing Ambroxol hydrochloride 30ug per lml, filtered, the continued filtrate was taken as the test solution, and 20 u1 was accurately measured, injected into the liquid chromatograph, and the chromatogram was recorded, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 30ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as Ambroxol hydrochloride.
specification
30mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:33:16
AMBROXOL HYDROCHLORIDE - Amroxol Hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of Ambroxol hydrochloride. Containing Ambroxol hydrochloride (C13H18Br2N20 • HCl) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear liquid from colorless to yellowish green.
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 0.1 mol/L hydrochloric acid solution is diluted to prepare a solution containing about 15ug of Ambroxol hydrochloride per 1 ml, which is determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at wavelengths of 244Nm and 308nm.
examination
- the pH value should be 3.5 to 5.5 (General 0631).
- clarity and color this product should be clear and colorless (General rule 0902 first method); If the color is colored, it should not be deeper compared with the yellow-green No. 3 Standard Colorimetric liquid (General rule 0901 first method).
- relevant substances: take 3ml of the product and put it in a 20ml measuring flask, dilute to the scale with mobile phase, shake well, and use it as a sample solution, in a 50ml measuring flask, dilute to scale with mobile phase, shake well, take 1 ml precisely, put it in a 50ml measuring flask, dilute to scale with mobile phase, shake well, and use as a control solution. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity I shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution, other single impurity peak area shall not be greater than the main peak area of the control solution (0.2% ) , and the sum of each impurity peak area shall not be greater than 5 times (1.0%) of the main peak area of the control solution.
- bacterial endotoxin this product, according to the law to check (General 1143), each 1 mg of Ambroxol hydrochloride containing endotoxin should be less than 0.50 EU.
- 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 eighteen alkyl silane bonded silica gel as filler (4.6mm X 150mm, 5um or performance equivalent column); O.Olmol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 248nm. About 5 m g of Ambroxol hydrochloride was added to dissolve in 0. 2ml of methanol, followed by 40 ^ 1 of formaldehyde solution (1-100). Shake well, heat in 60 1 water bath for 5 minutes, and blow dry with nitrogen. The residue was dissolved with 5ml of water, diluted to 20ml with mobile phase, 20 u1 was injected into the liquid chromatograph, and the resolution between Ambroxol peak and impurity I Peak (relative retention time is about 0.8) should be greater than 4.0.
- precision measurement: Take 1 ml of this product, put it in a 250ml measuring flask, dilute it to the scale with mobile phase, shake it, use it as a sample solution, take 20ul for precision measurement, and inject it into human liquid chromatograph, record the chromatogram; Take an appropriate amount of Ambroxol hydrochloride reference, precisely weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 30ug per lml, and determine with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as Ambroxol hydrochloride.
specification
(l ) lml:7.5mg ( 2 ) 2ml:15mg(3)4ml:30mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:33:17
AMBROXOL HYDROCHLORIDE - Ambroxol Hydrochloride Capsules
Authoritative Data Verified Data
This product contains Ambroxol hydrochloride (C13H18Br2N20 • HCl) should be 95.0% to 105.0% of the label.
trait
The content of this product is white or white particles 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.
- the solution under the item of dissolution was taken and measured by ultraviolet-visible spectrophotometry (General 0401), which showed maximum absorption at wavelengths of 244nm and 308nm.
examination
- relevant substances: take an appropriate amount of fine powder in the contents of this product, dissolve it with mobile phase and dilute it to make a solution containing 1 mg of Ambroxol hydrochloride in each lml, filter it, and take the continued filtrate as the test solution; take 1ml of precision, 100ml flask, diluted with mobile phase to scale, shake, as a control solution. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931, the first method), hydrochloric acid solution (9-1000) 100 m as the dissolution medium, the rotation speed is rpm, operate in accordance with the law, after 30 minutes, take an appropriate amount of the solution to filter, take a precise amount of filtrate, continue to take 5ml, put it in a 10ml measuring flask, dilute to the scale with dissolution medium, shake well, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 244nm; Take appropriate amount of Ambroxol hydrochloride reference, the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 15ug per 1 ml, which was determined by the same method, and the dissolution amount of each particle was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- 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 with eighteen alkyl silane bonded silica gel as filler; O.Olmol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 248mn. About 5mg of Ambroxol hydrochloride was taken, dissolved with 0.2ml of methanol, and then 40ul of formaldehyde solution (1-100) was added. The mixture was shaken well, heated in a 60 ° C. Water bath for 5 minutes, and dried under nitrogen. The residue was dissolved with 5ml of water, diluted to 20ml with mobile phase, and then injected with 20u1 into the liquid chromatograph. The resolution between Ambroxol peak and impurity I Peak (relative retention time is about 0.8) should be greater than 4.0.
- the content under the item of loading amount difference was measured, and the appropriate amount was accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 30ug of Ambroxol hydrochloride per 1 ml, and filtered, the continued filtrate was taken as the test solution, and 20 u1 was accurately measured. The liquid chromatograph was injected and the chromatogram was recorded, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 30ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as Ambroxol hydrochloride.
specification
30mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:33:18
AMBROXOL HYDROCHLORIDE - Ambroxol hydrochloride sustained-release capsules
Authoritative Data Verified Data
This product contains Ambroxol hydrochloride (C13H18Br2N20 • HCl) should be 95.0% to 105.0% of the label.
trait
The contents of this product are white or off-white pellets.
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.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of 248mn.
examination
- relevant substances: Take appropriate amount of fine powder of this product, add mobile phase to dissolve and dilute to prepare a solution containing 1 mg of Ambroxol hydrochloride per 1ml as a test solution; Take 1ml for precision measurement, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with sodium chloride hydrochloric acid solution (take 2g of sodium chloride, add an appropriate amount of water to dissolve, add hydrochloric acid 7ml, dilute with water to 1000ml,pH 1.2)1000ml as dissolution medium, speed is 50 rpm, operate according to law, after 1 hour, take 10ml solution filtration, take the filtrate as Test Solution (1); Then change to phosphate buffer (take potassium dihydrogen phosphate 6.805g, add 1 mol/L sodium hydroxide solution 22.4ml, add water to make 1000ml, PH = 6.8 ) 1000ml as dissolution medium, continue to operate according to law, and continuous time, after 2 hours and 4 hours, take 5ml solution respectively and filter, immediately, 5ml of the dissolution medium at the same temperature was replenished in the operating vessel. 2ml of the continuous filtrate was taken in each precise amount, and each was placed in a 10ml measuring flask, diluted to a scale with a dissolution medium, and shaken to obtain the test solution (2) and (3). Take the test solution (1), (2) and (3), according to UV-visible spectrophotometry (General rule 0401), at the wavelength of 244nm; Measure the absorbance; in addition, an appropriate amount of Ambroxol hydrochloride reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 25ug per lml, which was determined by the same method. The elution amount of each particle at different times was calculated separately. The dissolution amount of each capsule of this product in 1 hour, 2 hours and 4 hours shall be 15% ~ 45%, 45% ~ 80% and more than 80% of the labeled amount, and shall comply with the regulations.
- 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 with eighteen alkyl silane bonded silica gel as filler; O.Olmol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 248nm. Take about 5mg of Ambroxol hydrochloride, add 100 of methanol to dissolve, add 40 u1 of formaldehyde solution (1-), shake well, heat in 60°C water bath for 5 minutes, and blow dry with nitrogen. The residue is dissolved in 5ml of water, diluted to 20ml with mobile phase, and injected into the liquid chromatograph with 20ul. The resolution between Ambroxol peak and impurity I Peak (relative retention time is about 0.8) should be greater than 4.0.
- the content under the item of loading amount difference was measured, and the appropriate amount was accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 30ug of Ambroxol hydrochloride per 1 ml, and filtered, the continued filtrate was taken as the test solution, and 20ul of the sample was accurately measured. The liquid chromatograph was injected and the chromatogram was recorded, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 30ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as Ambroxol hydrochloride.
specification
75mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:33:18
AMBROXOL HYDROCHLORIDE - Ambroxol hydrochloride syrup
Authoritative Data Verified Data
This product contains Ambroxol hydrochloride (C13H18Br2N20 • HCI) should be 95.0% to 105.0% of the label.
trait
This product is a clear viscous 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 0.1 mol/L hydrochloric acid solution was diluted to prepare a solution containing about 30ug of Ambroxol hydrochloride per 1 ml, and the maximum absorption was determined by UV-visible spectrophotometry (General 0401) at a wavelength of 308nm.
examination
- relative density the relative density of this product (General 0601) is 1.10~1.30.
- clarity this product should be clear, if it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), not more concentrated.
- others shall comply with the relevant provisions under syrup (General rule 0116).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test with eighteen alkyl silane bonded silica gel as filler (4.0.01mol/L diammonium hydrogen phosphate solution (adjusted to pH 7.0 with phosphoric acid)-acetonitrile (50:50) as mobile phase; The detection wavelength was 248mn. About 5mg of Ambroxol hydrochloride was taken and dissolved with l-lOOMOpl of methanol. Then, formaldehyde solution () was added. The residue is dissolved by adding 5ml of water, diluted to 20ml with mobile phase, and then injected with 20u1 into HPLC. The resolution between Ambroxol peak and impurity I Peak (relative retention time is about 0.8) should be greater than 4.0.
- measuring method: Use internal volume pipette to precisely measure 2ml of the product, put it in a 100ml measuring flask, wash the inner wall of the pipette with mobile phase, wash the liquid into the measuring flask, dilute it to the scale with mobile phase, shake it well, take 5ml accurately, put it in a 20ml measuring flask, dilute to scale with mobile phase, shake well, use it as test solution, take 20 u1 accurately, inject human liquid chromatograph, record chromatogram; in addition, an appropriate amount of Ambroxol hydrochloride reference substance was accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 30ug per 1 ml, which was operated in the same manner. According to the external standard method to calculate the peak area, that is.
category
Same as Ambroxol hydrochloride.
specification
100ml:0.6g
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:33:19
AMBROXOL HYDROCHLORIDE - Reference Information
| use | cough medicine |
Last Update：2024-04-09 01:59:59
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