2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride
TRAMADOL|HCL
CAS: 22204-88-2
Molecular Formula: C16H26ClNO2
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Names and Identifiers
| Name | TRAMADOL|HCL |
| Synonyms | TRAMODOL HCL TRAMADOL HCL AURORA KA-863 TRAMADOL HYDROCHLORIDE Tramadol hydrochloride (-)-Tramadol hydrochloride CIS-TRAMADOL HYDROCHLORIDE O-DESMETHYL-CIS-TRAMADOL HCL 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride |
| CAS | 22204-88-2 |
| EINECS | 220-831-4 |
| InChI | InChI=1/C16H25NO2/c1-17(2)12-14-7-4-5-10-16(14,18)13-8-6-9-15(11-13)19-3/h6,8-9,11,14,18H,4-5,7,10,12H2,1-3H3 |
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Physico-chemical Properties
| Molecular Formula | C16H26ClNO2 |
| Molar Mass | 299.84 |
| Density | 1.047g/cm3 |
| Melting Point | 171°C |
| Boling Point | 388.1°C at 760 mmHg |
| Flash Point | 9℃ |
| Vapor Presure | 1.02E-06mmHg at 25°C |
| Storage Condition | 2-8°C |
| Refractive Index | 1.532 |
| Use | Analgesics for cancer pain, bone fractures and a variety of postoperative pain |
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Risk and Safety
| Risk Codes | R11 - Highly Flammable R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R39/23/24/25 - |
| Safety Description | S16 - Keep away from sources of ignition. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 2 |
| Toxicity | LD50 in mice, rats (mg/kg): 350, 228 orally; 200, 286 s.c. (Lagler) |
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Upstream Downstream Industry
| Raw Materials | Acetone Iodine Paraformaldehyde Dimethylamine 1,4-Dioxane Cyclohexanone Cyclohexane 3-Bromoanisole Ammonium chloride Tetrahydrofuran Copper(II) sulfate Hydrochloric acid |
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Differential diagnosis
Authoritative Data Verified Data
This product is (±)-(1RS,2RS)-2-[(N,N-dimethylamino) methylene]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Calculated as dry product, containing C16H25N02 • HC1 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Trait
Authoritative Data Verified Data
- This product is white crystal or crystalline powder; No odor; Has the hygroscopicity.
- This product is very soluble in water, soluble in ethanol or chloroform, slightly soluble in acetone, insoluble in ether.
melting point
The melting point of this product (General rule 0612 first method) is 179~182°C.
Last Update：2022-01-01 14:22:47
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 2mg of this product, add 3-4 drops of acetic anhydride citrate solution, and heat it in a water bath at about 90°C for 3-5 minutes to show purplish red color.
- take this product, add water to dissolve and dilute to make a solution containing 80ug per lml, and measure by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 270nm and a minimum absorption at a wavelength of 241NM.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 641).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:22:48
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Exam
Authoritative Data Verified Data
pH
take 0.lg of this product, add 10ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 4.5~8.5.
clarity of the solution
take this product l.Og, add water 10mr after dissolution, the solution should be clear.
Related substances
take the appropriate amount of this product, precision weighing, and mobile phase dissolution and quantitative dilution to make a solution containing about 2mg per 1 ml, as a test solution; Another CIS tramadol hydrochloride (impurity I) the solution containing 0.2mg per 1 ml was prepared as the reference solution. The sample solution (lml) and the reference solution (3ml) were accurately measured, in the same 100ml measuring flask, dilute to the scale with the mobile phase, shake, as a control solution. According to the high performance liquid chromatography (General 0512) test, silica gel bonded with eighteen alkyl silane was used as filler; Acetic acid-sodium acetate buffer (pH 4.5)-methanol (65:35) was used as mobile phase; the detection wavelength was 271mn. The number of theoretical plates shall not be less than 1500 based on Tramadol peak. The order of peak emergence is impurity I and tramadol, and the degree of separation between the two peaks should meet the requirements. 20 u1 of each of the control solution and the test solution were injected into the liquid chromatograph respectively, and the chromatogram was recorded to 3 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 impurity I, the peak area shall be calculated according to the external standard method, and the peak area shall not exceed 0.3%, the sum of the peak areas of each other impurity shall not be greater than 0.5 times (0.5%) the area of the tramadol peak in the control solution.
residual solvent
take an appropriate amount of this product, accurately weigh it, add water to dissolve and quantitatively dilute it to make a solution containing about 0.2g per lml as the test solution; Take the appropriate amount of isopropyl alcohol and dioxane respectively, precision weighing, adding water to dissolve and quantitatively dilute to prepare a mixed solution containing about 1 mg of isopropyl alcohol and 76ug of dioxane per 1 ml as a reference solution. 5ml of the test solution and 5ml of the reference solution were respectively put into 20ml headspace bottles, and lg of anhydrous sodium sulfate was added. The anhydrous sodium sulfate was dissolved by shaking and sealed. Determined according to the residual solvent assay (General 0861 second method). A capillary column with dimethyl polysiloxane (or similar polar) as a stationary liquid is used as a chromatographic column, the initial temperature is 70°C, and the temperature is maintained for 7 minutes, and the temperature is raised to 100°C at a rate of 30°C per minute for 5 minutes; the detector temperature was 250°C; The inlet temperature was 150°C. The Headspace bottle equilibration temperature was 90°C and the equilibration time was 30 minutes. The reference solution was injected in the headspace, and the chromatogram was recorded. The resolution between isopropanol peak and dioxane peak should meet the requirements. Then take the reference solution and the test solution into the headspace, and record the chromatogram. According to the external standard method to calculate the peak area, isopropanol and dioxane residues should be in accordance with the provisions.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (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 0.1%.
Heavy metals
The residue left under the item of ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821).
Last Update：2022-01-01 14:22:48
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Content determination
Authoritative Data Verified Data
take this product about 0.18g, precision weighing, add glacial acetic acid 10ml dissolved, add acetic anhydride 30ml, according to the potentiometric titration method (General rule 0701), with perchloric acid titration solution (O. 1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol /L) corresponds to 29.98mg of C16H25N02. Hc1.
Last Update：2022-01-01 14:22:49
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Category
Authoritative Data Verified Data
Analgesic.
Last Update：2022-01-01 14:22:49
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:22:49
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol Hydrochloride TahleLs
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C16H25N02 • HCI) should be 93.0% ~ 107.0% of the label amount.
trait
This product is white tablet.
identification
- take 4 tablets of this product, grind, add 5ml of water, shake to dissolve, filter, take 2 drops of filtrate, put it in a small tube, and evaporate on a water bath at 80°C, add 1 drop of test solution of citric acid and acetic anhydride (2-100) and heat it in a water bath at 80-90 ° C. For 3-5 minutes to show purplish red color.
- 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 filtrate under Item (1) was taken as chloride to identify the reaction of (1) (General 0301).
examination
- Under the content determination of related substances, the appropriate amount of fine powder is accurately weighed, dissolved and diluted with mobile phase to prepare a solution containing about 2mg of tramadol hydrochloride per 1 ml, which is shaken and filtered, take the continued filtrate as the test solution; Take an appropriate amount of the reference substance of impurity I, weigh it accurately, and use the mobile phase to make a solution containing about 0.2mg per 1 ml as the reference solution; the sample solution (1 ml) and the control solution (3ml) were accurately weighed and placed in the same 100ml measuring flask, and diluted to the scale with the mobile phase to serve as a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of tramadol hydrochloride shall not be exceeded, the sum of the peak areas of other impurities shall not be greater than the tramadol peak area in the control solution (1.0%).
- dissolution: according to the dissolution and release determination method (General rule 0931 method 1), 0.01mol/L hydrochloric acid solution was used as dissolution medium at 100 rpm, operate according to law, after 10 minutes, take 10ml of the solution, filter, take the continued filtrate as the test solution (50mg specification); Or take the appropriate amount of the continued filtrate, A solution containing about 50ug of tramadol hydrochloride per 1 ml is prepared by diluting with a dissolution medium as a test solution (lOOmg specification) according to UV-Vis spectrophotometry (General 0401), the absorbance was measured at a wavelength of 270mn; The appropriate amount of tramadol hydrochloride was weighed accurately, and 0. The Olmol /L hydrochloric acid solution was dissolved and quantitatively diluted into a solution containing about 50ug of tramadol hydrochloride per 1 ml, and the dissolution amount of each tablet was calculated by the same method. The limit is 80% 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 using eighteen alkyl silane bonded silica as filler; Acetic acid-sodium acetate buffer (pH 4.5)-methanol (65:35) as mobile phase; the detection wavelength was 271nm. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 50mg equivalent to tramadol hydrochloride), put in a 100ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake well, filter, take the continued filtrate as the test solution, and inject 20ul into the liquid chromatograph with precise quantity, record the chromatogram; Take the appropriate amount of tramadol hydrochloride reference substance, and weigh it accurately, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.5mg 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 tramadol hydrochloride.
specification
(l)50m g (2)100mg
storage
sealed storage.
Last Update：2022-01-01 14:22:50
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol hydrochloride dispersible tablets
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C16H25NO2 • HCl) should be 93.0% ~ 107.0% of the label amount.
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.
- take an appropriate amount of the fine powder of this product (about 25mg of tramadol hydrochloride), add an appropriate amount of water to dissolve and quantitatively dilute to a solution containing about 80ug of tramadol hydrochloride per 1 ml, as determined by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of nm and a minimum absorption at a wavelength of Nm.
- take an appropriate amount of the fine powder of this product, add water, shake to dissolve tramadol hydrochloride, filter, and the filtrate shows chloride to identify the reaction of (1) (General rule 0301).
examination
- the appropriate amount of fine powder under the content determination item of related substances is accurately weighed, dissolved and diluted with mobile phase to prepare a solution containing about 2mg of tramadol hydrochloride per 1 ml, shaken and filtered, take the continued filtrate as the test solution; Take an appropriate amount of the reference substance of impurity I, weigh it precisely, add the mobile phase to dissolve and dilute to make a solution containing about 0.2mg per 1 ml, and use it as the reference solution; the sample solution (1 ml) and the control solution (3ml) were accurately weighed and placed in the same 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of tramadol hydrochloride shall not be exceeded, the sum of the peak areas of other impurities shall not be greater than the tramadol peak area in the control solution (1.0%).
- dissolution: according to the dissolution and release determination method (General rule 0931 method), 100 ml of mol /L hydrochloric acid solution was used as dissolution medium, operate according to law, after 10 minutes, take 10ml of solution, filter, take filtrate, according to UV-visible spectrophotometry (General rule 0401), measure absorbance at the wavelength of 270nm; an appropriate amount of tramadol hydrochloride reference substance was added for precision weighing and O.Olmol /L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 50ug of tramadol hydrochloride per 1 ml, which was measured by the same method and the dissolution amount of each tablet was calculated. The limit is 80% 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 using eighteen alkyl silane bonded silica as filler; Acetic acid-sodium acetate buffer (pH 4.5)-methanol (65:35) as mobile phase; the detection wavelength was 271nm. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to tramadol hydrochloride 25mg), put it in a 50ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake, filter, take the continued filtrate as the test solution, take 20 u1 with precision, inject into the liquid chromatograph, record the chromatogram; Take an appropriate amount of tramadol hydrochloride reference substance, precision weigh, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.5mg 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 tramadol hydrochloride.
specification
50mg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 14:22:51
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol Hydrochloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of tramadol hydrochloride. Containing Tramadol hydrochloride (C16H25N02 • HCl) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product (about 2mg equivalent to tramadol hydrochloride), put it on a water bath and evaporate it to dryness, then add 3-4 drops of acetic anhydride solution, heating in a water bath at about 90°C for 3-5 minutes, I .e., purplish red.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 5.0 to 7.0 (General 0631).
- precise amount of related substances: Take appropriate amount of this product and dilute it with mobile phase to prepare a solution containing about 2mg of tramadol hydrochloride per 1 ml as a test solution; Take appropriate amount of reference substance of impurity I and weigh it precisely, add the mobile phase to dissolve and make a solution containing about 0.2mg per 1 ml, which is used as the reference solution; Take the sample solution (1 ml) and the reference solution (3ml) precisely and put them in the same 100ml measuring flask, the mobile phase was diluted to the scale and used as a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of tramadol hydrochloride shall not be exceeded, the sum of the peak areas of other impurities shall not be greater than the tramadol peak area in the control solution (1.0%).
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg tramadol hydrochloride containing endotoxin amount should be less than 0.75EU.
- 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 as filler; Acetic acid-sodium acetate buffer (pH 4.5)-methanol (65:35) as mobile phase; the detection wavelength was 271mn. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- determination precision: take an appropriate amount of this product (about 50mg equivalent to tramadol hydrochloride), put it in a 100ml measuring flask, dilute it with the mobile phase to the scale, shake it well, and use it as a test solution, 20u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. An appropriate amount of tramadol hydrochloride reference substance was weighed accurately, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 0.5mg 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 tramadol hydrochloride.
specification
( l )2ml:50mg (2)2ml:lOOmg
storage
light shielding, closed storage.
Last Update：2022-01-01 14:22:52
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol hydrochloride suppositories
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C16H25N02 • HCl) should be 90.0% to 110.0% of the label.
trait
This product is white or white suppository.
identification
- take an appropriate amount of this product (approximately equivalent to tramadol hydrochloride O.lg), add 5ml of water, heat and stir to dissolve tramadol hydrochloride, let it cool, filter, take 2ml of filtrate, evaporate in 80°C water bath, add 1 drop of test solution of citric acid acetic anhydride, the mixture was heated in a water bath at 80-90°C for 3-5 minutes to show purplish red color.
- 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 aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- Take appropriate amount of minced sample under the content determination item of related substances, weigh it precisely, add appropriate amount of mobile phase, put it in a hot water bath, shake it to dissolve tramadol hydrochloride, and let it cool, dilute with mobile phase and make a solution containing about 2mg of tramadol hydrochloride in each lml, filter through a filter membrane, as a test solution; Take an appropriate amount of impurity I reference substance, and weigh it accurately, add the mobile phase to dissolve and dilute to make a solution containing about 0.2mg per 1 ml, which is used as the reference solution; Take the sample solution (1 ml) and the reference solution (3ml) precisely, and put them in the same 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of tramadol hydrochloride shall not be exceeded, the sum of the peak areas of other impurities shall not be greater than the tramadol peak area in the control solution (1.0%).
- others should comply with the relevant provisions under suppository (General rule 0107).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; Acetic acid-sodium acetate buffer (pH 4.5 )-methanol (65:35) as mobile phase; the detection wavelength was 271mn. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- determination of sample 10, precision weighing, chopping, mixing, precision weighing an appropriate amount (equivalent to tramadol hydrochloride 50mg), 100ml flask, add the appropriate amount of mobile phase, place in a hot water bath, shake to dissolve tramadol hydrochloride, let it cool, dilute to scale with mobile phase, shake well, filter through 0.45um filter, and take the continued filtrate as the test solution, the chromatogram was recorded by injection of 20u1 into human liquid chromatograph, and the appropriate amount of tramadol hydrochloride reference substance was weighed accurately, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 0.5mg 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 tramadol hydrochloride.
specification
O.lg
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:22:53
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol hydrochloride capsules
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C16H25N02 • HCl) should be 90.0% to 110.0% of the label.
trait
The content of this product is white powder.
identification
- Take appropriate amount of the content of this product, add water to make tramadol hydrochloride decanted, filter, take filtrate, according to tramadol hydrochloride identification (1), (2), (4) test, the same results.
- 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
- the appropriate amount of fine powder under the content determination item of related substances is accurately weighed, dissolved and diluted with mobile phase to prepare a solution containing about 2mg of tramadol hydrochloride per 1 ml, shaken and filtered, take the continued filtrate as the test solution; Take an appropriate amount of the reference substance of impurity I, weigh it precisely, add the mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.2mg per 1 ml, and use it as the reference solution; the sample solution (1 ml) and the control solution (3ml) were accurately weighed and placed in the same 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of tramadol hydrochloride shall not be exceeded, the sum of the peak areas of other impurities shall not be greater than the tramadol peak area in the control solution (1.0%).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with water as the dissolution medium, the speed of 100 rpm, according to the law. After 20 minutes, 10ml of the solution was taken, filtered, and the filtrate was taken according to UV-visible spectrophotometry (General rule 0401), and the absorbance was measured at the wavelength of 270nm, precision weighing, dissolved and quantitatively diluted with water to make a solution containing about 50ug per lml, the same method for determination. Calculate the amount of dissolution of each grain, the limit is 80% of the label amount, should be consistent 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 using eighteen alkyl silane bonded silica as filler; Acetic acid-sodium acetate buffer (pH 4.5)-methanol (65:35) as mobile phase; the detection wavelength was 271mn. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- determine the content under the item of loading difference, grind it finely, weigh an appropriate amount (about 50mg equivalent to tramadol hydrochloride) precisely, put it in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, filter, take the continued filtrate as the test solution, take 20u1 injection of human liquid chromatography with precision, record the chromatogram; Take the appropriate amount of tramadol hydrochloride reference, precision weigh, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.5mg 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 tramadol hydrochloride.
specification
50mg
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 14:22:54
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol hydrochloride sustained-release tablets
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C16H25N02 • HCl) should be 93.0% to 107.0% of the label.
trait
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- take an appropriate amount of the fine powder of this product (equivalent to 0.2g of tramadol hydrochloride), add 5ml of water, shake to dissolve tramadol hydrochloride, filter, take 4 drops of the filtrate and put it in a small tube, and evaporate it in a water bath at 80°C, add 1 drop of acetic acid acetic anhydride test solution, and heat it in a water bath at 80-90 ° C. For 3-5 minutes to show purplish red color.
- 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 aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- appropriate amount of fine powder under the content determination item of related substances is accurately weighed, dissolved and diluted with mobile phase to make a solution containing about 2mg of tramadol hydrochloride per 1 ml, and filtered, as a test solution; Another appropriate amount of impurity I reference, precision weighing, adding mobile phase to dissolve and dilute to make a solution containing about 0.2mg per 1 ml, as a reference solution; the sample solution (1 ml) and the control solution (3ml) were accurately weighed and placed in the same 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated according to the external standard method, and 0.3% of the labeled amount of tramadol hydrochloride shall not be exceeded, the Peak area of other individual impurities shall not be greater than 0.5 times (0.5%) of the peak area of Tramadol in the control solution, and the sum of the peak areas of other individual impurities shall not be greater than the peak area of Tramadol in the control solution (1.0%).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, at 1 hour, 2 hours, 4 hours and 8 hours, take 10ml of the solution respectively, filter, and immediately add the same volume of water at the same temperature, take the filtrate, according to UV-visible spectrophotometry (General rule 0401), determine absorbance at 271nm wavelength; Take appropriate amount of tramadol hydrochloride reference substance, water was added to dissolve and diluted to prepare a solution containing about 80ug per 1 ml, which was determined by the same method. The dissolution amount of each tablet at different times was calculated separately. The dissolution amount of each tablet in 1 hour, 2 hours, 4 hours and 8 hours should be 25% ~ 45%, 35% ~ 55%, 50% ~ 80% and 80% of the label amount respectively, all 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 using eighteen alkyl silane bonded silica as filler; Acetic acid-sodium acetate buffer (pH 4.5 )-methanol (65:35) as mobile phase; the detection wavelength was 271nm. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 50mg equivalent to tramadol hydrochloride), put in a 100ml measuring flask, add an appropriate amount of mobile phase, ultrasonic dissolution of tramadol hydrochloride, dilute to the scale with mobile phase, shake, filter, take the continued filtrate as the test solution, take 20u1 injection of human liquid chromatography with precision, record the chromatogram; Take an appropriate amount of tramadol hydrochloride control, precision weighing, and mobile phase dissolution and quantitative dilution made of each 1 ml containing about 0.5mg of the solution, the same method. According to the external standard method to calculate the peak area, that is.
category
Same as tramadol hydrochloride.
specification
O.lg
storage
sealed, stored in a cool and dry place.
Last Update：2022-01-01 14:22:55
2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-1-cyclohexanol hydrochloride - Tramadol hydrochloride sustained-release capsules
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C16H25N02 • HCI) should be 90.0% ~ 110.0% of the label amount.
trait
The contents of this product are white or off-white small pills or tablets.
identification
- take an appropriate amount of the fine powder of the content of this product (about 0.2g of tramadol hydrochloride), add 5ml of water, shake to dissolve tramadol hydrochloride, filter, take 4 drops of the filtrate and put it into a small tube, after evaporating in a water bath at 80°C, 1 drop of the test solution of citric acid acetic anhydride was added, and the mixture was heated in a water bath at 80-90°C for 3-5 minutes to show a purplish red color.
- 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 aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- relevant substances: take an appropriate amount of the contents of this product (about 0.2g of tramadol hydrochloride), weigh it accurately, put it in a 100ml measuring flask, add 35ml of methanol, and dissolve tramadol hydrochloride by ultrasound, add about 40ml of acetic acid-sodium acetate buffer (pH 4.5), mix well, cool, dilute to the scale with acetic acid-sodium acetate buffer (pH 4.5), shake well, filter, take the continued filtrate as the test solution; Take an appropriate amount of the reference substance of impurity I, weigh it precisely, and add the mobile phase to make a solution containing about 0.2m g per 1 ml, as the reference solution; the sample solution (1 ml) and the control solution (3ml) were accurately weighed and placed in the same 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to obtain a control solution. According to the method of tramadol hydrochloride related substances. If there is a chromatographic peak consistent with the retention time of impurity I in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method. 3%, the peak area of other single impurities shall not be greater than 0.5 times (0.5%) of the peak area of Tramadol in the control solution, and the sum of the peak areas of other impurities shall not be greater than the peak area of Tramadol in the control solution (1.0%).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with water as the dissolution medium, the speed of 100 rpm, according to the law. At 1 hour, 2 hours, 4 hours and 8 hours, 10ml of the solution was filtered, and the same volume and temperature of water were immediately added, and the filtrate was taken, according to UV-visible spectrophotometry (General rule 0401), determine absorbance at 271nm wavelength; Take appropriate amount of tramadol hydrochloride reference substance, water was added to dissolve and diluted to prepare a solution containing about 80ug per 1 ml, and the same method was used to calculate the dissolution amount of each particle at different times. The dissolution amount of each capsule in 1 hour, 2 hours, 4 hours and 8 hours should be 20% ~ 45%, 35% ~ 60%, 55% ~ 80% and 75% of the label amount respectively, all 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 using eighteen alkyl silane bonded silica as filler; Acetic acid-sodium acetate buffer (pH 4.5)-methanol (65:35) as mobile phase; the detection wavelength was 271nm. The number of theoretical plates shall not be less than 1500 based on Tramadol peak.
- the content under the item of difference in loading amount was weighed appropriately (about 50mg equivalent to tramadol hydrochloride), placed in a 100ml measuring flask, and 35ml methanol was added, followed by dissolving tramadol hydrochloride by ultrasound, add acetic acid-sodium acetate buffer (pH 4.5) about 40ml, shake, cool, dilute to the scale with acetic acid-sodium acetate buffer (pH 4.5), shake, filter, the continued filtrate was taken as the test solution, and 20u1 was accurately weighed and injected into the human liquid chromatograph to record the chromatogram, the mobile phase was added to dissolve and diluted to make a solution containing 0.5mg 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 tramadol hydrochloride.
specification
0.lg
storage
sealed, stored in a cool place.
Last Update：2022-01-01 14:22:56
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