SERTRALINE MANDELATE
Sertraline HCL
CAS: 79559-97-0
Molecular Formula: C17H18Cl3N
SERTRALINE MANDELATE - Names and Identifiers
| Name | Sertraline HCL |
| Synonyms | SETRALINE HCL Sertraline HCL SERTRALINE MANDELATE SERTRALINE HCL FORM I SERTRALINE HCL FORM II SERTRALINE HYDROCHLORIDE sertraline hydrochloride 4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine (1S,4S)-4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPTHALENAMINE HYDROCHLORIDE (1s,4s)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-n-methyl-1-napthalenamine hydrochloride (1S,4S)-4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPHTHALENAMINE HYDROCHLORIDE (1S,4S)-1-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-4-(METHYLAMINO)NAPHTHALENE HYDROCHLORIDE |
| CAS | 79559-97-0 |
| EINECS | 616-702-0 |
| InChI | InChI=1/C17H17Cl2N.ClH/c1-20-17-9-7-12(13-4-2-3-5-14(13)17)11-6-8-15(18)16(19)10-11;/h2-6,8,10,12,17,20H,7,9H2,1H3;1H/t12-,17-;/m0./s1 |
SERTRALINE MANDELATE - Physico-chemical Properties
| Molecular Formula | C17H18Cl3N |
| Molar Mass | 342.69 |
| Density | 1.37 |
| Melting Point | 246-249°C |
| Boling Point | 416.3°C at 760 mmHg |
| Specific Rotation(α) | D23 +37.9° (c = 2 in methanol) |
| Flash Point | 9℃ |
| Solubility | DMSO: ~26 mg/mL |
| Vapor Presure | 3.85E-07mmHg at 25°C |
| Appearance | White solid |
| Color | white |
| Merck | 14,8467 |
| pKa | pKa (water): 9.48 ± 0.04; pKa (methanol:water, 40:60 v/v): 8.6; pKa (ethanol:water, 1:1 v/v): 8.5(at |
| Storage Condition | 2-8°C |
| Stability | Store in Freezer |
| MDL | MFCD00895772 |
| Physical and Chemical Properties | Melting point 246-249°C |
| Use | Used as an antidepressant |
SERTRALINE MANDELATE - Risk and Safety
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. 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. S7 - Keep container tightly closed. |
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 3 |
| RTECS | QJ0352070 |
| HS Code | 29214990 |
| Hazard Class | IRRITANT |
SERTRALINE MANDELATE - Reference
| Reference Show more | 1. [IF=8.071] Shuangshuang Zhu et al."Antidepressant sertraline impairs the induced morphological defense of Ceriodaphnia cornuta in response to Chaoborus larvae kairomone."Environ Pollut. 2020 Nov;266:115092 2. [IF=5.81] Lihong Zhang et al."An Integrative Pharmacology-Based Strategy to Uncover the Mechanism of Xiong-Pi-Fang in Treating Coronary Heart Disease with Depression."Front Pharmacol. 2021; 12: 590602 |
SERTRALINE MANDELATE - Standard
Authoritative Data Verified Data
This product is (15,45)-4-(3, 4-dichlorophenyl)-1,2,3, 4-tetraoxy-n-methyl-1-naphthylamine hydrochloride. The content of C17H17C12N • HCl shall not be less than 98.5% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
SERTRALINE MANDELATE - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is dissolved in methanol or ethanol, and is almost insoluble in water.
Last Update：2022-01-01 15:06:24
SERTRALINE MANDELATE - Differential diagnosis
Authoritative Data Verified Data
- take this product, dissolve and dilute with ethanol to make a solution containing about 0.2mg per lml, and measure by UV-Vis spectrophotometry (General rule 0401), at 266nm, 274nm and 282nm at the wavelength of the maximum absorption.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 835).
- ethanol-water (1:1) solution of this product can identify (1) reaction (General 0301).
Last Update：2022-01-01 15:06:25
SERTRALINE MANDELATE - Exam
Authoritative Data Verified Data
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing 0.5mg sertraline per 1ml 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 5ml, 100ml flask, diluted with mobile phase to the scale, shake, as a sensitivity solution. According to the high performance liquid chromatography (General rule 0512) test, using octyl silane bonded silica gel as filler; Using ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 5.75g, add triethylamine 5ml, add water to dissolve and dilute to 1000ml, adjust pH to 5.0 with phosphoric acid)-methanol (35:65) as mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 2000 calculated by sertraline peak, and the separation degree between sertraline peak and adjacent impurity peaks shall meet the requirements. Accurately measure the sensitivity solution 20 u1 and inject it into the liquid chromatograph. The signal-to-noise ratio of the peak height of the main component should be greater than 10, the chromatogram was recorded to 2.5 times the retention time of the main 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 the main peak area of the control solution (1.0%). The chromatographic peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored (0.05%).
isomer
take this product, add mobile phase to dissolve and dilute to make about sertraline 0.1 mg of the solution as a test solution; Take 1ml of the precision volume, put it in a 100ml measuring flask, dilute it to the scale with the mobile phase, shake it, and use it as a control solution; Take 1ml of the control solution with the precision volume, in a 20ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a sensitivity solution. In addition, appropriate amounts of mixed reference products of sertraline hydrochloride, impurity II, impurity I and impurity III were added with a small amount of ethanol to dissolve, and then diluted with mobile phase to prepare about 0.1 mg of sertraline hydrochloride per 1 ml, impurity I, the solution of each lug of impurity II and impurity III was used as a system-applicable solution. Amylose-Tris (3, 5-dimethylphenylcarbamate) silica gel was used as filler (Chiralpak AD-H, 0512 X 4.6mm, 5um or performance equivalent column); N-hexane-ethanol-diethylamine (95:5:0.2) as mobile phase; Flow rate of 0.8 per minute; Column temperature of 20°C. The detection wavelength was 223nm. The system applicable solution 20u1 is injected into the liquid chromatograph, and the chromatogram is recorded. The order of peaks is sertraline, impurity I, impurity II and impurity III, the degree of separation of the sertraline peak from impurity I and from each impurity peak should meet the requirements. Precision Measurement of the sensitivity of the 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 chromatograms were recorded. If there are chromatographic peaks consistent with the retention time of the above impurities in the chromatogram of the test solution, the sum of the peak areas of each impurity shall not be greater than the main peak area of the control solution (1.0%). The chromatographic peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored (0.05%).
residual solvent
take this product about O.lg, precision weighing, top empty bottle, Precision Add 5ml of N, N-dimethylformamide, shake to dissolve, seal, as a test solution; Another methanol, ethanol, ethyl acetate, Tetrahydrofuran, isopropyl alcohol and N-butyl alcohol each appropriate amount, precision weighing, with N, N-dimethylformamide quantitative dilution made of methanol containing about 0.06mg per 1 ml, ethanol 0.1 mg, ethyl acetate 0.1 mg, tetrahydrofuran 0.0144mg, isopropanol 0.lmg with n-butanol 0.1 mg of the mixed solution was accurately weighed into 5ml, placed in a headspace bottle, and sealed as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as the stationary liquid is the column; The initial temperature is 40°C, hold for 5 minutes, then raise the temperature to 120°C at a rate of 10°C per minute for 5 minutes; The inlet temperature is 200°C; The detector temperature is 250°C; The equilibrium temperature of the headspace bottle is 80°C, the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree between the chromatographic peaks should meet the requirements. Then the reference solution and the test solution were injected into the headspace, and the chromatographic curve was recorded. According to the external standard method to calculate the peak area, methanol, ethanol, ethyl acetate, Tetrahydrofuran, isopropanol and n-butanol 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 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 15:06:26
SERTRALINE MANDELATE - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add anhydrous glacial acetic acid 0701 and acetic anhydride 30ml, ultrasonic dissolution, cool, according to the potential titration method (general), with perchloric acid titration solution (0.1 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 34.27mg of C17H17C12N. Hc1.
Last Update：2022-01-01 15:06:26
SERTRALINE MANDELATE - Category
Authoritative Data Verified Data
antidepressants.
Last Update：2022-01-01 15:06:26
SERTRALINE MANDELATE - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:06:26
SERTRALINE MANDELATE - Zoloft (Sertraline Hydrochloride Tablets)
Authoritative Data Verified Data
This product contains sertraline hydrochloride according to Sertraline (C17H17C12N), should be 90.0% ~ 110.0% 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 reference solution.
- take an appropriate amount of the fine powder of this product, add ethanol to dissolve sertraline hydrochloride and dilute it to make a solution containing about 0.2mg sertraline per 1 ml, filter it, and take the filtrate, absorption maxima were determined by UV-Vis spectrophotometry (General 0401) at wavelengths of 266mn, 274mn and 282nm.
- take the fine powder of this product about O. 1G, 5ml of ethanol-water (1: 1) was added, and the sertraline hydrochloride was dissolved by shaking, filtered, and the filtrate showed chloride to identify the reaction of (1) (General 0301).
examination
- relevant substances: Take appropriate amount of fine powder of this product, add mobile phase to dissolve and dilute sertraline hydrochloride to make a solution containing 0.5mg sertraline per 1ml, filter, and take the continued filtrate as the 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 5ml of the control solution accurately and put it in a 100ml measuring flask, dilute to the scale with the mobile phase and shake well as a sensitivity solution. According to the method of sertraline hydrochloride related substances. 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%). The chromatographic peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with pH 4.5 sodium acetate buffer (sodium acetate 3G, add glacial acetic acid 1.6, dilute with water to 1000ml, if necessary, use glacial acetic acid to adjust the pH value to 4.5)900ml as the dissolution medium, the rotation speed is 50 rpm, operate according to law, after 45 minutes, take the appropriate amount of solution, filter, take the continued filtrate as the test solution; Take an appropriate amount of sertraline hydrochloride reference substance, weigh it precisely, and add a small amount of methanol to dissolve it, A solution containing about 50ug of sertraline per 1 ml was prepared as a control solution by quantitative dilution with sodium acetate buffer at pH 4.5. According to the method under the content determination item, the dissolution amount of each tablet was 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 octyl silane bonded silica gel as filler; Ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 5.75g, add triethylamine 5ml, add water to dissolve and dilute to 1000ml, the pH value was adjusted to 5.0 with phosphoric acid)-methanol (35:65) as mobile phase; The detection wavelength was 220mn; The number of theoretical plates was not less than 2000 based on the sertraline peak.
- determination of this product 20 tablets, precision weighing, fine grinding, take an appropriate amount (equivalent to sertraline 10mg ), Precision weighing, plus the appropriate amount of mobile phase, ultrasonic dissolution and quantitative dilution of sertraline hydrochloride into a solution containing about 0.05mg of sertraline per lml, shake well, filter, take the continued filtrate as the test solution, and take 20 u1 with precision, injection liquid chromatograph, record chromatogram; Another sertraline hydrochloride reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as sertraline hydrochloride.
specification
50mg (based on C17H17Cl2N)
storage
sealed storage.
Last Update：2022-01-01 15:06:27
SERTRALINE MANDELATE - Sertraline hydrochloride capsules
Authoritative Data Verified Data
This product contains sertraline hydrochloride according to Sertraline (C17H17C12N), should be 90.0% ~ 110.0% of the label amount.
trait
The contents of this product are white or off-white powder or granules.
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 contents of this product, add ethanol to dissolve sertraline hydrochloride and dilute it to make a solution containing about 0.2mg sertraline per 1 ml, filter it, and take the filtrate, absorption maxima were determined by UV-Vis spectrophotometry (General 0401) at wavelengths of 266nm, 274nm and 282nm.
- take about 0.LG of the fine powder of this product, add ethanol-water (1:l)5ml, shake to dissolve sertraline hydrochloride, filter, filtrate chloride to identify (1) reaction (General rule 0301).
examination
- Related substances the contents of this product are mixed evenly, appropriate amount is taken, and the mobile phase is added to dissolve and dilute sertraline hydrochloride to make a solution containing 0.5mg of sertraline per 1 ml, which is filtered, take the continued filtrate as the test solution; Take 1 ml of the precision volume, put it in a 100ml measuring flask, dilute it to the scale with the mobile phase, shake it, and use it as the control solution; Take 5ml of the precision control solution, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a sensitivity solution. According to the method of sertraline hydrochloride related substances. 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 pH 4.5 sodium acetate buffer (sodium acetate 1.6g, add glacial acetic acid, add water to dilute to 1000ml, if necessary, use glacial acetic acid to adjust the pH value to 4.5)900ml as the dissolution medium, the rotation speed is 75 rpm, operate according to law, after 30 minutes, take appropriate amount of solution, filter, take the continued filtrate as the test solution; Take an appropriate amount of sertraline hydrochloride reference substance, weigh it precisely, and add a small amount of methanol to dissolve it, A solution containing about 50ug of sertraline per 1 ml was prepared by quantitative dilution with sodium acetate buffer at pH 4.5, and was shaken to be used as a control solution. According to the method under the content determination item, the dissolution amount of each particle was 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 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 octyl silane bonded silica gel as filler; Ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 5.75g, add triethylamine 5ml, add water to dissolve and dilute to 1000ml, the pH value was adjusted to 5.0 with phosphoric acid)-methanol (35:65) as mobile phase; The detection wavelength was 220nm; The number of theoretical plates was not less than 2000 according to the sertraline peak.
- determination of content under the item of loading amount difference, mix evenly, take appropriate amount (equivalent to sertraline 10mg ), Precision weighing, add appropriate amount of mobile phase, ultrasonic dissolution and quantitative dilution of sertraline hydrochloride into a solution containing about 0.05mg of sertraline per lml, shake well, filter, take the continued filtrate as the test solution, and take 20 u1 with precision, injection of human liquid chromatography, record chromatogram; Another sertraline hydrochloride reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
Same as sertraline hydrochloride.
specification
50mg (based on C17H17C12N)
storage
sealed storage.
Last Update：2022-01-01 15:06:28
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