3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl-
Paliperidone
CAS: 144598-75-4
Molecular Formula: C23H27FN4O3
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Names and Identifiers
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Physico-chemical Properties
| Molecular Formula | C23H27FN4O3 |
| Molar Mass | 426.48 |
| Density | 1.45±0.1 g/cm3(Predicted) |
| Melting Point | 158-160°C |
| Boling Point | 612.3±65.0 °C(Predicted) |
| Flash Point | 9℃ |
| Solubility | DMSO: soluble2mg/mL, clear (warmed) |
| Vapor Presure | 0mmHg at 25°C |
| Appearance | off-white to pale orange solid |
| Color | white to brown |
| pKa | 13.00±0.60(Predicted) |
| Storage Condition | 2-8°C |
| Stability | Stable for 2 years from date of purchase as supplied. Solutions in DMSO may be stored at -20° for up to 2 months. |
| Refractive Index | 1.692 |
| MDL | MFCD00871802 |
| In vitro study | Paliperidone significantly increased the intracellular accumulation of Rh123 and DOX in a concentration-dependent manner. Paliperidone acts well on Aβ(25-35) and MPP(+) at low concentrations (10 and 50 μm), and only protects SH-SY5Y from hydrogen peroxide damage. Paliperidone (100 μm) completely reduced the cell reduction induced by different pressures, regardless of its dose. Paliperidone has a higher oxidative stress-scavenging effect than other APDs in many ways, such as the production of large amounts of glutathione, low HNE, and protein carbonyl products. Paliperidone enhanced dopamine toxicity at the highest dose and was the only AP that significantly increased cell viability (8.1%) compared to cells treated with dopamine alone. |
| In vivo study | Paliperidone restores extracellular glutamate in the basal layer of rat prefrontal cortex. In rats, Paliperidone also protects against acute MK-801-induced increases in extracellular glutamate. The combined administration of Paliperidone with Escitalopram restored the inhibition of the firing rate of NE neurons and the percentage of sudden firing of neurons. Paliperidone reduced biting and aggressive behavior in a dose-dependent manner at effective doses. Paliperidone leads to a significant reduction in aggressive behavior. |
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Risk and Safety
| Risk Codes | R25 - Toxic if swallowed R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | UV1164720 |
| HS Code | 29349990 |
| Hazard Class | 6.1 |
| Packing Group | III |
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Reference
| Reference Show more | 1. [IF=6.057] Wen-Hua Ji et al."A water-compatible magnetic molecularly imprinted polymer for the selective extraction of risperidone and 9-hydroxyrisperidone from human urine."Talanta. 2018 May;181:392 2. [IF=3.119] Jinrui Zhang et al."In silico study on identification of novel MALT1 allosteric inhibitors."Rsc Adv. 2019 Nov;9(67):39338-39347 |
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Standard
Authoritative Data Verified Data
This product is 3-[2-[4-(6-fluoro -1, 2-benzisoparone -3-yl)-1-piperidinyl] ethyl]-6,7, 8, 9-tetrahydro-2-methylpyrido [1,2-a] pyrimidin-4-one. Calculated as dried product, the content of C23H27FN402 shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder.
- This product is dissolved in methanol, slightly soluble in ethanol, almost insoluble in water; Slightly soluble in O.lmol/L hydrochloric acid.
melting point
The melting point of this product (General rule 0612) is 169~173°C, and the melting distance shall not exceed 2°C.
Last Update：2022-01-01 11:57:52
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Differential diagnosis
Authoritative Data Verified Data
- appropriate amounts of this product and the risperidone reference substance were respectively added with mobile phase ultrasound to dissolve and dilute to prepare a solution containing about 20ug per 1 ml as the test solution and the reference solution. 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 according to the chromatographic conditions under the relevant substances.
- the sample solution under identification (1) was determined by UV-Vis spectrophotometry (General rule 0401), and the maximum absorption was found at the wavelength of 277nm, there is minimal absorption at a wavelength of 253mn.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
Last Update：2022-01-01 11:57:53
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Exam
Authoritative Data Verified Data
chloride
take 0.20g of this product, Add 10ml of dilute nitric acid to dissolve it, and check it according to law (General rule 0801). Compared with the control solution made of 2.0ml of standard sodium chloride solution, it should not be more concentrated (0.01%).
sulfate
take this product l. Add 40ml of water, boil, cool, filter, take filtrate, check according to law (General rule 0802), compared with the control solution made of 0.01% of standard potassium sulfate solution, not more concentrated ().
Related substances
take about 25mg of this product, put it in a 50ml measuring flask, add an appropriate amount of mobile phase, ultrasonic dissolve risperidone, let it cool, dilute it to the scale with mobile phase, shake well, and use it as a test solution; take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it, and use it as a control solution. Take 1ml of the control solution accurately and put it in a 20ml measuring flask, dilute to the scale with the mobile phase and shake well as a sensitivity solution. According to the test of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as filler; Methanol -0.05mol/L ammonium acetate solution (pH value was adjusted to 7.0 with ammonia test solution)(60:40) as mobile phase; The detection wavelength is 234nm, the number of theoretical plate is not less than 5000 according to the risperidone peak, and the separation degree of risperidone peak and adjacent impurity peak should meet the requirements. Take the sensitivity of solution 20u1 injection liquid chromatography, the signal to noise ratio of the main component peak height should be greater than 10. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.2 times (0.2%) of the area of the main peak of the control 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
methanol, acetone, isopropanol, acetonitrile, methane, N-hexane, ethyl acetate and toluene take this product about 0.30g, precision weighing, top empty bottle, precision plus N, N-dimethylformamide 5ml sealed, 70°C water bath heating for 10 minutes to dissolve, as a test solution; Respectively, precision weighing methanol 180mg, acetone 300mg, isopropanol 300mg, acetonitrile 24.6mg, 17.5mg, N-hexane 53.4mg, ethyl acetate 300mg and toluene mg were added to a 100ml measuring flask containing an appropriate amount of N, N-dimethylformamide and diluted to the mark with N, N-dimethylformamide, shake well, take 5ml accurately, put it in a 50ml measuring flask, dilute it to the scale with N, N-dimethylformamide, shake well, take 5ml accurately in the headspace bottle, seal it, and use it as a reference solution. Determined according to the residual solvent assay (General 0861 second method). The capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polarity) as the stationary liquid was used as the chromatographic column; The initial temperature was 40°C and maintained for 15 minutes, heating to 100°C at a rate of 10°C per minute for 3 minutes, heating to 200°C at a rate of 30°C per minute for 5 minutes; Injection temperature of 200°C; the temperature of the detector is 250°C; The equilibrium temperature of the headspace bottle is 85°C, and the equilibrium time is 20 minutes; The headspace injection of the reference solution is taken, the chromatogram is recorded, and the separation degree between the peaks of each component shall meet the requirements. Then the test solution and the reference solution are injected in the headspace respectively, the chromatogram is recorded, and the peak area is calculated according to the external standard method, and the residual amount shall be in accordance with the regulations.
precision weighing of chloroform and N ,N-dimethylformamide
take an appropriate amount of this product, add dimethyl sulfoxide to dissolve and dilute to make a solution containing 40mg per lml as a test solution; Separately weigh chloroform, N, an appropriate amount of N-dimethylformamide and dimethyl sulfoxide were added to prepare a solution containing 2.4ug of trichloromethane and 35.2ug of N ,N-dimethylformamide per 1 ml as a reference solution. Determined according to the residual solvent determination method (General 0861 third method). The capillary column with 5% diphenyl-95% dimethyl polysiloxane as stationary liquid is used as the chromatographic column; The injection temperature is 100°C, the detector temperature is 260°C, and the initial temperature is 50°C, which is maintained for 5 minutes, heat up to 175°C at a rate of 5°C per minute, and then heat up to 260°C at a rate of 35°C per minute for 20 minutes; Accurately take the control solution 1u1 and inject it into the chromatograph, record the chromatogram, the separation degree between peaks of each component shall meet the requirements. Then sample the test solution and the reference solution respectively, record the chromatogram, calculate the peak area according to the external standard method, and the residual amount shall be in accordance with the regulations.
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
This product l.Og, inspection according to law (General rule 0841), residual flooding shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 11:57:54
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Content determination
Authoritative Data Verified Data
take this product 0.15g, precision weighing, add glacial acetic acid 20ml shaking to dissolve, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (0.1 mol/L) titration to a clear blue color of the solution, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution corresponds to 20.52mg of C23H27FN402.
Last Update：2022-01-01 11:57:54
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Category
Authoritative Data Verified Data
antipsychotics.
Last Update：2022-01-01 11:57:54
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:57:54
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Risperidone oral solution
Authoritative Data Verified Data
This product contains risperidone (C23H27FN402) should be labeled the amount of 95.0% to 105.0%.
trait
This product is colorless to yellowish clear liquid.
identification
In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
examination
- the pH value should be 2.5 to 4.0 (General 0631).
- the color of this product, compared with the yellow No. 2 Standard Colorimetric liquid (General Principles 0901 first method), should not be deeper.
- take 5ml of the product, put it in a 10ml measuring flask, dilute it to the scale with mobile phase, shake it, and use it as a test solution. Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute with mobile phase to the scale, shake, as a control solution; Precision take the control solution 1ml, put in 20ml flask, diluted with mobile phase to the scale, shake, as a sensitivity solution. The determination was carried out according to the method for related substances of risperidone. If there are impurity peaks in the chromatogram of the test solution (the peaks before the relative retention time of 0.43 are not counted), the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- take 5ml of benzoic acid, put it in a 100ml measuring flask, dilute it to scale with mobile phase, shake it well, and use it as a test solution. Take about 15mg of benzoic acid reference substance, and weigh it accurately, in a 100ml measuring flask, the mobile phase was added to dissolve and dilute to the scale, and the solution was shaken as a reference solution. According to the chromatographic conditions under the content determination item, the detection wavelength is 280mn, and 20 u1 of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded, according to the external standard method to calculate the peak area, each lml containing benzoic acid shall not exceed 3mg.
- 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 (Agilent Extend C18,4.6mm x 250mm,5um or equivalent column); the mobile phase was methanol -0.05mol/L ammonium acetate solution (adjusted to pH 7.0 with ammonia solution)(60:40), and the detection wavelength was 234nm. The flow rate was adjusted so that the retention time of the risperidone peak was approximately 8 minutes. The number of theoretical plates shall not be less than 5000 calculated by risperidone peak, and the separation degree between risperidone peak and adjacent impurity peaks shall meet the requirements.
- determination precision measure 2ml of this product, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, use it as a sample solution, and take 20 u1 for precision measurement, note human liquid chromatograph, record chromatogram; Take risperidone reference substance about 10 mg, precision weighing, put it in 50ml measuring flask, add mobile phase to dissolve and dilute to scale, shake well, take 5ml precision, in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and measure with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as risperidone.
specification
30ml:30mg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:57:55
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Risperidone orally disintegrating tablets
Authoritative Data Verified Data
This product contains lipeisi (C23H27O2) should be 90.0% -110.0% of the amount of the standard.
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 the test solution under the content determination item, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 277mn, there is minimal absorption at a wavelength of 253Nm.
examination
- relevant substances: take an appropriate amount of the fine powder of this product (about 5mg equivalent to risperidone), place it in a 10ml measuring flask, add an appropriate amount of mobile phase, sonicate the risperidone to dissolve, cool, and dilute to the scale with mobile phase, shake well, filter, and take the filtrate as the test solution; Take 1ml accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake well, and use it as the control solution; 1ml of the control solution was accurately measured, placed in a 20ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a sensitivity solution. The determination was carried out according to the method for related substances of risperidone. If there are impurity peaks in the chromatogram of the test solution (the peaks before the relative retention time of 0.3 are not counted), the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.500ml of 1 mol/L hydrochloric acid solution is the dissolution medium, the rotation speed is 50 revolutions per minute, the operation is carried out according to law, after 15 minutes, the solution is filtered, and the filtrate is taken as the test solution; in addition, an appropriate amount of risperidone reference substance is accurately weighed, dissolved and quantitatively diluted with dissolution medium to make a solution containing about lug(0.5mg specification), 2ug (1 mg specification) or 4ug(2mg specification) per lml, as a control solution. The detection wavelength was 280nm according to the chromatographic conditions under the content measurement. 50ul of the test solution and the reference solution are respectively injected into the liquid chromatograph to record the chromatogram, and the dissolution amount of each tablet is calculated by the peak area according to the external standard 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 gel as filler (Agilent Extend C18,4.6mm x 250mm, 5um or equivalent chromatographic column with methanol -0.05mol/L ammonium acetate solution (with ammonia solution to adjust the pH value to 7.0)(60:40) as mobile phase; the detection wavelength was 234nm and the flow rate was adjusted so that the retention time of the risperidone peak was about 8 minutes. The number of theoretical plates shall not be less than 5000 calculated by risperidone peak, and the separation degree between risperidone peak and adjacent impurity peaks shall meet the requirements.
- determination Method: Take 10 tablets of this product, put them respectively in 25ml(0.5mg specification) or 50ml (1 mg specification) or 100ml(2mg specification) measuring flasks, add appropriate amount of mobile phase, and ultrasonic to dissolve risperidone, cool, dilute to scale with mobile phase, shake well, filter, take the filtrate as the test solution, and inject 20ul into human liquid chromatograph with precision, record the chromatogram; Take an appropriate amount of risperidone reference, precision weighing, plus mobile phase dissolution and quantitative dilution of the solution containing about 20ug per 1 ml, as a reference solution, the same method. According to the external standard method, the content of each tablet is calculated by Peak area, and the average content of 10 tablets is obtained.
category
Same as risperidone.
specification
(1 )0.5mg (2 )lmg (3)2mg
storage
light-shielded, sealed, and preserved in a dry place.
Last Update：2022-01-01 11:57:56
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Risperidone tablets
Authoritative Data Verified Data
This product contains risperidone (C23H27FN402) should be labeled the amount of 90.0% to 110.0%.
trait
This product is a film-coated tablet, white or off-white after removal of the coating.
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 the test solution under the content determination item, according to UV-visible spectrophotometry (General rule 0401), there is a maximum absorption at the wavelength of 277nm, there is minimal absorption at a wavelength of 253Nm.
examination
- relevant substances: take an appropriate amount of the fine powder of this product (about 5mg equivalent to risperidone), place it in a 10ml measuring flask, add an appropriate amount of mobile phase, sonicate the risperidone to dissolve, cool, and dilute to the scale with mobile phase, shake, centrifuge, filter, and take the filtrate as the test solution; Take 1ml in a precision measurement, put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake well, and use as the control solution; 1ml of the control solution was accurately measured, placed in a 20ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a sensitivity solution. The determination was carried out according to the method for related substances of risperidone. If there are impurity peaks in the chromatogram of the test solution (the peaks before the relative retention time of 0.3 are not counted), the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%). The content uniformity of
- shall be calculated from the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.500ml of 1 mol/L hydrochloric acid solution is the dissolution medium, the rotation speed is 50 revolutions per minute, the operation is carried out according to law, after 30 minutes, the solution is filtered, and the filtrate is taken as the test solution; in addition, an appropriate amount of risperidone reference substance is accurately weighed, dissolved and quantitatively diluted with dissolution medium to make a solution containing about 2ug(lmg specification), 4ug(2mg specification) or 6ug(3mg specification) per lml, as a control solution. According to the method under the content determination item, the detection wavelength is 280mn, and the number of theoretical plates is not less than 3000 according to the risperidone peak. The sample solution and the reference solution of 50 u1 were respectively injected into the liquid chromatograph, and the chromatogram was recorded. The dissolution amount of each tablet was calculated by peak area according to the external standard 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 using eighteen alkyl silane bonded silica gel as filler (Agilent Extend C18,4.6mm x 250mm, 5um or equivalent column); the mobile phase consisted of methanol -0.05mol/L ammonium acetate solution (adjusted to pH 7.0 with ammonia solution)(60:40); the detection wavelength was 234mn. The flow rate was adjusted so that the retention time of the risperidone peak was about 8 minutes. The number of theoretical plates shall not be less than 5000 calculated by risperidone peak, and the separation degree between risperidone peak and adjacent impurity peaks shall meet the requirements.
- determination of 10 tablets of this product, respectively, in 50ml(lmg specification) or 100ml(2mg, 3mg specification) measuring flask, add appropriate amount of mobile phase, ultrasonic dissolution of risperidone, cool, dilute with mobile phase to the scale, shake, centrifuge, filter, take the filtrate as the test solution; Take the appropriate amount of risperidone control, precision weighing, A solution containing about 20ug (1 mg, 2mg specification) or 3ug (3mg specification) per 1 ml was prepared by dissolving and quantitatively diluting with a mobile phase as a control solution. 20 u1 of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. According to the external standard method, the content of each tablet is calculated by the peak area, and the average content of 10 tablets is obtained.
category
Same as risperidone.
specification
(l) lmg (2)2mg (3)3mg
storage
sealed storage.
Last Update：2022-01-01 11:57:57
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl- - Risperidone capsules
Authoritative Data Verified Data
This product contains risperidone (C23H27FN402) should be labeled the amount of 90.0% to 110.0%.
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.
- take the test solution under the content determination item, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 277mn, there is minimal absorption at a wavelength of 253Nm.
examination
- relevant substances the contents of this product were finely divided, and an appropriate amount (about 5mg equivalent to risperidone) was added to a 10ml measuring flask. An appropriate amount of mobile phase was added, and the risperidone was dissolved by ultrasound and allowed to cool, dilute to the scale with mobile phase, shake well, filter through the filter, take the filtrate as the test solution; Take 1ml with precision, put it in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, as a control solution. The control solution (1 ml) was accurately weighed, placed in a 20ml measuring flask, diluted to the scale with mobile phase, and shaken to obtain a sensitivity solution. The determination was carried out according to the method for related substances of risperidone. If there are impurity peaks in the chromatogram of the test solution (the peaks before the relative retention time of 0.3 are not counted), the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- Content uniformity take 1 capsule of this product, pour the contents into a 50ml measuring flask, and use 0.1 mol/L hydrochloric acid solution wash, wash and 50ml flask, add 0.lmol/L hydrochloric acid solution appropriate amount, ultrasonic dissolution of risperidone, cold, with 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake, filter, take the filtrate as the test solution; Take the appropriate amount of risperidone control, precision weighing, add 0.1 mol/L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 20ug per 1 ml as a reference solution. Take the sample solution and the reference solution, according to ultraviolet-visible spectrophotometry (General rule 0401), at the wavelength of 274mn absorbance were measured, calculate the content, should comply with the provisions (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.500ml of 1 mol/L hydrochloric acid solution is the dissolution medium, and the rotation speed is 50 rpm, which is operated according to law. After 30 minutes, the solution is filtered, and 15ml of the initial filtrate is discarded, the continued filtrate was taken as the test solution; The appropriate amount of the risperidone reference substance was accurately weighed, and the dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 1 ml per 1 ml as the reference solution. According to the chromatographic conditions under the content determination item, 50 u1 of the test solution and 50 u1 of the reference solution are accurately measured, and the human liquid chromatograph is injected respectively to record the chromatogram, according to the external standard method, the dissolution amount of each particle was calculated by the peak area. 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 using eighteen alkyl silane bonded silica gel as filler (Agilent Extend C18,4.6mm x 250mm,5um or equivalent column); the mobile phase was methanol -0.05mol/L ammonium acetate solution (adjusted to pH 7.0 with ammonia solution)(60:40), and the detection wavelength was 234nm. The flow rate was adjusted so that the retention time of the risperidone peak was approximately 8 minutes. The number of theoretical plates shall not be less than 5000 calculated by risperidone peak, and the separation degree between risperidone peak and adjacent impurity peaks shall meet the requirements.
- determination method: take the contents of 20 capsules of this product, precise weighing, fine mixing, precise weighing appropriate amount (about 2mg equivalent to risperidone), put it in a 100ml measuring flask, and add appropriate amount of mobile phase, the risperidone was dissolved by ultrasound, allowed to cool, diluted to scale with mobile phase, shaken, filtered, and the continued filtrate was taken as the test solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 20ug per 1 ml as a control solution. 20 u1 of the test solution and the reference solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
category
Same as risperidone.
specification
lmg
storage
sealed preservation.
Last Update：2022-01-01 11:57:58
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Multiple SpecificationsSpot supply
Product Name: Paliperidone Visit Supplier Webpage Request for quotationCAS: 144598-75-4
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Multiple SpecificationsSpot supply
Product Name: Paliperidone Visit Supplier Webpage Request for quotationCAS: 144598-75-4
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Multiple SpecificationsSpot supply
Product Name: Paliperidone Visit Supplier Webpage Request for quotationCAS: 144598-75-4
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
View History
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-Methyl-