(3s-trans)-id
Paroxetine HCL
CAS: 78246-49-8
Molecular Formula: C19H21ClFNO3
(3s-trans)-id - Names and Identifiers
(3s-trans)-id - Physico-chemical Properties
| Molecular Formula | C19H21ClFNO3 |
| Molar Mass | 365.83 |
| Melting Point | 129-131°C |
| Boling Point | 451.7°C at 760 mmHg |
| Flash Point | 227°C |
| Vapor Presure | 2.39E-08mmHg at 25°C |
| Appearance | neat |
| Storage Condition | 2-8°C |
| Physical and Chemical Properties | melting point 129-131°C |
| Use | Antidepressants |
(3s-trans)-id - Risk and Safety
| UN IDs | 3249 |
| HS Code | 29339900 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
(3s-trans)-id - Standard
Authoritative Data Verified Data
This product is (1)-(3S,4R)-4-(4-fluorophenyl)-3-[(3, 4-methylenedioxy) phenoxy] methyl] piperidine hydrochloride hemihydrate. C19H20FN03 • HCl shall not be less than 98.5% calculated as anhydrous and solvent-free.
Last Update：2024-01-02 23:10:35
(3s-trans)-id - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is soluble in methanol, soluble in ethanol, slightly soluble in acetone, very slightly soluble in water; Almost insoluble in 0.lmol/L hydrochloric acid solution.
specific rotation
take this product, precision weighing, add methanol to dissolve and quantitatively dilute the solution containing lOmg per lml, and determine according to law (General 0621), the specific rotation is from one to 88 ° to one to 91 °.
Last Update：2022-01-01 15:06:20
(3s-trans)-id - Differential diagnosis
Authoritative Data Verified Data
- take this product, add methanol to dissolve and make a solution containing 50ug per lml, according to UV-visible spectrophotometry (General 0401), at 235nm, 265nm, 27lnm and 295nm wavelength has the maximum absorption. The ratio of the absorbance at a wavelength of 235nm to the absorbance at a wavelength of 295nm should be 0.92 to 0.96.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- This product shows the identification reaction of organic fluoride (General rule 0301).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:06:20
(3s-trans)-id - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water, heat to dissolve, cool, and determine according to law (General 0631),pH value should be 5.5~6.5.
isomer
take this product, precision weigh, add methanol to dissolve and quantitatively dilute to make a solution containing about 1 mg per 1ml, as a test solution; Take 1ml for precision, in a 100ml measuring flask, dilute to the scale with methanol, shake well, and use as a control solution, methanol was added to dissolve and diluted to make each containing 0. A mixed solution of 1 mg is used as a system-applicable solution. a-acid glycoprotein bonded silica gel was used as a filler (0512 × 4.0mm, 5um) as determined by high performance liquid chromatography (General 11.4), 1000ml of water was added to dissolve, and the pH value was adjusted to 6.5 with phosphoric acid. Acetonitrile (94:6) was used as mobile phase; The detection wavelength was 295nm, and the column temperature was 30°C. Take the system applicable solution 10u1 and inject it into human Liquid Chromatograph. The resolution of paroxetine peak and trans-paroxetine peak should be greater than 2.2. Take 10ul of control solution and 10ul of test solution, respectively inject human liquid chromatograph, record chromatogram. If there is a trans-paroxetine peak in the chromatogram of the test solution, the peak area shall not be greater than 0.1 times (0.1%) of the main peak area of the control solution.
Related substances
This product was taken, dissolved and diluted with a solvent [tetrahydrofuran-water (1:9 )] to prepare a solution containing about 1 mg per 1 ml as a test solution. An appropriate amount was taken in a precise amount and quantitatively diluted with a solvent to prepare a solution containing about 1 ug per 1 ml as a control solution. Take the control of paroxetine hydrochloride, desfluraxetine (impurity I) and N-methylparoxetine (impurity II), dissolve with solvent and dilute to prepare 10% mixed solution per 1 ml, as a system suitability solution. According to the high performance liquid chromatography (General 0512) test, with octyl silane bonded silica gel as filler; With trifluoroacetic acid-tetrahydrofuran-water (5:100:900) as mobile phase A, trifluoroacetic acid-tetrahydrofuran-acetonitrile (5:100:900) was used as mobile Phase B, and gradient elution was carried out according to the following table. The detection wavelength was 295mn. Take 20ul of the applicable solution of the system, inject the human liquid chromatograph, record the chromatogram, the order of peaks are impurity I, impurity II and paroxetine, paroxetine peak, the degree of separation between the impurity I peak and the impurity D peak should be greater than 2.5. 20 u1 of the control solution and the test solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. 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 not be greater than the main peak area of the control solution (0.1%), other single impurity peak area shall not be greater than the main peak area of the control solution (0.1%), and the sum of each impurity peak area shall not be greater than 5 times (0.5%) of the main peak area of the control solution. The chromatogram of the test solution is 0.5 times smaller than the main peak area of the control solution.
residual solvent
take this product about 2.0g, precision weighing, put it in 20ml measuring flask, Precision Add internal standard solution (take the right amount of N-propanol, with dimethyl sulfoxide to make a solution containing about 5mg per 1 ml) 2ml, diluted with dimethyl sulfoxide to the scale, shake, as a test solution. Accurately weigh the appropriate amount of methanol, ethanol, acetone, Tetrahydrofuran, pyridine and toluene, and use dimethyl methylene to make 3mg, 5mg, 5mg and 0.72mg for each lml, 0.2mg and 0.89mg of the solution were used as the reference stock solution; 5ml of each of the reference stock solution and the internal standard solution were accurately weighed, placed in a 50ml measuring flask, diluted to the scale with dimethyl sulfoxide, and shaken, as a control solution. Take 10ml of each of the reference solution and the test solution, respectively place them in the headspace bottle and seal them. According to the test for determination of residual solvents (General rule 0861 second method), the capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polarity) as stationary liquid is used as the column; The initial temperature is 50 ℃, hold for 10 minutes, raise the temperature to 80°C at a rate of 6°C per minute, hold for 5 minutes, then raise the temperature to 150°C at a rate of 40°C per minute, hold for 5 minutes; The equilibrium temperature of the headspace bottle is 90°C, the equilibration time was 30 minutes. The reference solution is injected into the headspace, and the chromatogram is recorded. The number of theoretical plates is not less than 10000 based on the N-propanol peak, and the separation degree of each component peak shall meet the requirements. Then take the reference solution and the test solution into the headspace respectively, record the chromatogram, according to the internal standard method to calculate the peak area, methanol, ethyl fermentation, acetone, Tetrahydrofuran, the residues of pyridine and toluene shall be in accordance with the regulations.
moisture
take this product, according to the determination method of moisture (General 0832 first method 1), the water content is divided into 2.0% ~ 3.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of burning residues shall be inspected according to law (General Principles 0821, Law II) and shall not contain more than 10 parts per million of heavy metals.
Last Update：2022-01-01 15:06:22
(3s-trans)-id - Content determination
Authoritative Data Verified Data
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Take ammonium acetate 3.96g, add water 720ml to dissolve, add acetonitrile 280ml, triethylamine 10ml, using glacial acetic acid to adjust the pH value to 5.5 as mobile phase, the detection wavelength was 295nm. Take 5mg of paroxetine hydrochloride, 5mg of impurity I and 5mg of impurity II respectively, put them in the same 10ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake well, and use as system applicable solution, take 20u1 injection human liquid chromatograph and record chromatogram. The order of peaks is impurity I, paroxetine and impurity II. The number of theoretical plates shall not be less than 3000 based on paroxetine peak, the resolution between the paroxetine peak, the impurity I peak and the impurity II peak should meet the requirements.
- determination method: take about 10mg of this product, weigh it accurately, put it in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake it well, and use it as a test solution, A 20ul injection liquid chromatograph was used for precise measurement, and the chromatogram was recorded. The paroxetine hydrochloride reference substance was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:06:22
(3s-trans)-id - Category
Authoritative Data Verified Data
antidepressants.
Last Update：2022-01-01 15:06:22
(3s-trans)-id - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:06:23
(3s-trans)-id - Paroxetine hydrochloride tablets
Authoritative Data Verified Data
This product contains paroxetine hydrochloride in Paroxetine (C19H20FN03), should be 93.0% ~ 107.0% of the label amount.
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 control solution.
examination
- Related substances take an appropriate amount of the fine powder of this product (about 50mg equivalent to paroxetine), put it in a 50ml measuring flask, add mobile phase to dissolve paroxetine hydrochloride and dilute to the scale, shake well, filter, the filtrate was taken as a test solution; 1 ml was accurately measured, placed in a 100ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a control solution. According to the chromatographic conditions under the item of paroxetine hydrochloride content determination, 20 u1 of the control solution and the sample solution were accurately measured, and human liquid chromatography was injected respectively, 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 sum of each impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
- Content uniformity take 1 tablet of this product, put it in a 100ml measuring flask, add appropriate amount of mobile phase, ultrasonic dissolve paroxetine hydrochloride, dilute to the scale with mobile phase, shake, filter, precise amount of continuous filtrate, diluted with mobile phase to make about O per 1 ml. lmg solution, according to the method under the content determination, according to the law to determine, calculate the content, should comply with the provisions (General Principles 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with hydrochloric acid solution (9-1000) 1000ml as the dissolution medium, the rotation speed is 50 rpm, according to the law, after 45 minutes, 20ml of the solution was taken, filtered, and the filtrate was taken as the test solution. Add about 23mg of paroxetine hydrochloride reference product to a 100ml measuring flask, add 5ml of toluene to dissolve paroxetine hydrochloride, dilute to the scale with dissolution medium, and shake well, in a 50ml measuring flask, dilute to the scale with dissolution medium, and shake to serve as a reference solution. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution 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
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing take an appropriate amount (about equivalent to paroxetine 10 mg), dissolved and diluted with mobile phase to make about 0 per 1 ml. 1 mg of the solution was shaken, filtered, and the filtrate was taken. As a test solution, it was obtained by measuring according to the method under the item of paroxetine hydrochloride content measurement.
category
antidepressants.
specification
20mg (based on C19H20FN03)
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:06:23
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