Fluoxetine Hydrochloride (200 mg)
fluoxetine hydrochloride
CAS: 59333-67-4;56296-78-7
Molecular Formula: C17H19ClF3NO
Fluoxetine Hydrochloride (200 mg) - Names and Identifiers
| Name | fluoxetine hydrochloride |
| Synonyms | SARAFEM Alzac 20 Affectine Fluoxetin HCL Fluoxetine HCL Fluoxetinhydrochloride fluoxetine hydrochloride Fluoxetine Hydrochloride (200 mg) N-METHYL-3-[(4-TRIFLUOROMETHYL)PHENOXY]-3-PHENYLPROPYLAMINE HYDROCHLORIDE N-Methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propylamine hydrochloride 6,11-dihydroxy-3,3-dimethyl-5-(3-methylbut-2-en-1-yl)-3,12-dihydro-7H-pyrano[2,3-c]acridin-7-one HCL |
| CAS | 59333-67-4 56296-78-7 |
| EINECS | 611-817-2 |
| InChI | InChI=1S/C17H18F3NO.ClH/c1-21-12-11-16(13-5-3-2-4-6-13)22-15-9-7-14(8-10-15)17(18,19)20;/h2-10,16,21H,11-12H2,1H3;1H |
Fluoxetine Hydrochloride (200 mg) - Physico-chemical Properties
| Molecular Formula | C17H19ClF3NO |
| Molar Mass | 345.79 |
| Density | 1.254g/cm3 |
| Melting Point | 158-159°C |
| Boling Point | 569.2°C at 760 mmHg |
| Flash Point | 9℃ |
| Solubility | H2O: 4mg/mL |
| Vapor Presure | 1.47E-13mmHg at 25°C |
| Appearance | solid |
| Color | white |
| Storage Condition | -20°C Freezer |
| Stability | Stable. Incompatible with strong oxidizing agents. |
| Refractive Index | 1.63 |
| MDL | MFCD00214288 |
| Use | For the treatment of moderate and refractory depression |
Fluoxetine Hydrochloride (200 mg) - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R38 - Irritating to the skin R41 - Risk of serious damage to eyes R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. 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. |
| WGK Germany | 3 |
| RTECS | UI4050000 |
| HS Code | 29221990 |
| Hazard Class | IRRITANT |
| Toxicity | LD50 in mice, rats (mg/kg): 248, 452 orally (Stark) |
Fluoxetine Hydrochloride (200 mg) - Reference
| Reference Show more | 1. Li Yunan, Qi Qi Wen, Zhang Ming, et al. Experimental study of gardenia-Chuanxiong drugs against depression based on network pharmacology [J]. Chinese Journal of Comparative Medicine, 2020, 030(005):47-53. |
Fluoxetine Hydrochloride (200 mg) - Standard
Authoritative Data Verified Data
This product is (±)-n-methyl-3-phenyl-3-(4-trifluoromethylphenoxy) propylamine hydrochloride. The content of c17h18f3 No. HCl should be between 98.0% and 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
Fluoxetine Hydrochloride (200 mg) - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is soluble in methanol or ethanol, slightly soluble in water or chloroform, insoluble in ether.
Last Update：2022-01-01 15:07:05
Fluoxetine Hydrochloride (200 mg) - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 837).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:07:05
Fluoxetine Hydrochloride (200 mg) - Exam
Authoritative Data Verified Data
optical rotation
take this product, precision weighing, add water-methanol solution (15:85) to dissolve and quantitatively dilute to make a solution containing about 20mg per lml, and determine according to law (General 0621), the optical rotation is from 0.05 ° to +0.05 °.
acidity
take an appropriate amount of this product, accurately weigh it, add an appropriate amount of water, ultrasonic to dissolve and quantitatively dilute it into a solution containing about 10 mg per lml, let it cool, and determine it according to law (General rule 0631), the pH should be between 4.5 and 6.5.
clarity and color of solution
take the right amount of this product, precision weighing, add water-methanol solution (15:85) to dissolve and dilute to make a solution containing about 20mg per lml, the solution should be clear and colorless; if it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method); If it is colored, it should not be deeper compared with yellow No. 1 Standard Colorimetric solution (General rule 0901 first method).
Related substances
take about 140mg of this product, put it in a 25ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as a test solution; Take 2ml for precision measurement, put it in a 100ml measuring flask, dilute to scale with mobile phase, shake, take 5ml with precision, put it in 100ml measuring flask, dilute to scale with mobile phase, shake, use as control solution; Take 5ml with precision, set in a 10ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a sensitivity solution. Take fluoxetine hydrochloride about 22mg, put it in a stopper tube, add 0.5mol/L sulfuric acid solution 10ml, water bath at 85°C for 3 hours, let it cool, this solution contains impurity I and impurity II; take 0.4ml of this solution, put it in a 25ml measuring flask, and take fluoxetine hydrochloride about 28mg, impurity ID control and impurity IV control about 1 mg respectively, put it in the above 25ml measuring flask, dissolve and dilute to the scale with the mobile phase as the system suitability solution. The detection wavelength was 215nm according to the chromatographic conditions under the content measurement. Take 10ul of the applicable solution of the system, inject human liquid chromatograph, adjust the proportion of mobile phase, so that the retention time of the main component peak is 10~18 minutes, the peak order is impurity I, impurity III, impurity IV, fluoxetine and impurity II (relative retention time is about 0.23,0.26,0.94,1.0 and 3.3, respectively), except that the separation degree between impurity I peak and impurity ID peak should be greater than 1.0, the degree of separation between other peaks should meet the requirements. Take the sensitivity of l0ul injection solution into the liquid chromatograph, the signal to noise ratio of the main component peak height should be greater than 10. Take 10 u1 of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram to 4 times of the retention time of the main component peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of impurity I, impurity III and impurity IV, the Peak area of impurity I and impurity III shall not be greater than 2.5 times (0.25%) of the main peak area of the control solution, and the peak area of impurity IV shall not be greater than 1.5 times (0.15%) of the main peak area of the control solution; other single impurity peak area shall not be greater than the main peak area of the control solution (0.1%), 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 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 about 0.1kg of this product, precision weighing, top empty bottle, Precision Add 2ml of N ,N-dimethylformamide, shake to dissolve, seal, as a test solution; another precision weighing methanol, acetonitrile, n-hexane, ethyl acetate and toluene each appropriate amount, plus IV,IV-dimethylformamide dissolved and diluted to make each lml containing about 150ug of methanol, acetonitrile 20.5ug, respectively, the mixed solution of n-hexane 14.5ug, ethyl acetate 250ug and toluene 44.5ug was accurately measured and 2ml was placed in the headspace bottle, sealed and used as the 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, maintain for 7 minutes, at a rate of 10°C per minute to 110°C, and then at a rate of 20°C per minute to 200°C, maintain for 10 minutes; The temperature of the sample inlet is 200°C; the detector temperature was 250°C; The headspace bottle equilibration temperature was 90°C and the equilibration time was 40 minutes. Take the reference solution into the headspace, and the separation degree between the peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the external standard method, the residual amount of methanol, acetonitrile, n-hexane, ethyl acetate and toluene 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
take 1.0g of this product, place it in a uranium crucible, and inspect it according to law (General rule 0841). The remaining residue 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 after examination by law (General rule 0821, Law II).
Last Update：2022-01-01 15:07:06
Fluoxetine Hydrochloride (200 mg) - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
octyl silane-bonded silica gel as a filler (Agilent Zorbax Eclipse Plus C 8, 4.6mm X 250mm,5um or equivalent column); Triethylamine buffer solution (take 10ml of triethylamine, 980ml of water was added, shaken, adjusted to pH 6.0 with phosphoric acid, diluted to ML with water)-methanol-tetrahydrofuran (62:8:30) as mobile phase; Detection wavelength was 227nm.
assay
take about 55mg of this product, weigh it accurately, put it in a 50ml measuring flask, add an appropriate amount of mobile phase to dissolve fluoxetine hydrochloride and dilute it to the scale, shake it well, take 5ml with precision, place it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, use it as a test solution, take 10 u1 precisely, inject it into human liquid chromatograph, record the chromatogram, and take an appropriate amount of fluoxetine hydrochloride reference substance, same method determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:07:07
Fluoxetine Hydrochloride (200 mg) - Category
Authoritative Data Verified Data
antidepressants.
Last Update：2022-01-01 15:07:07
Fluoxetine Hydrochloride (200 mg) - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:07:07
Fluoxetine Hydrochloride (200 mg) - Fluoxetine Hydrochloride tables
Authoritative Data Verified Data
This product contains fluoxetine hydrochloride by fluoxetine (c17h18f3 no), should be 90.0% ~ 110.0% of the label amount.
trait
This product is white tablet.
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 fine powder of this product (about 20mg equivalent to fluoxetine), add 10ml of dichloromethane, fully shake, filter, and evaporate the filtrate on a water bath and dry it at 105°C for 30 minutes, the residue shall be determined by infrared spectrophotometry (General rule 0402), and the infrared absorption spectrum of the test article shall be consistent with that of the control (Spectrum set 837).
- Take appropriate amount of fine powder of this product, add appropriate amount of water, fully shake, filter, filtrate shows chloride to identify (1) reaction (General rule 0301).
examination
- Related substances take an appropriate amount of the fine powder of this product (about 50mg of fluoxetine), put it in a 25ml measuring flask, add an appropriate amount of mobile phase, shake it thoroughly, dilute it to the scale with the mobile phase, shake it well, and filter it, take the continued filtrate as the test solution; Take 5ml of precision measurement, put it in 50ml measuring flask, dilute it with mobile phase to scale, shake well, take 2ml of precision measurement and put it in 100ml measuring flask, dilute with mobile phase to the scale, shake, as a control solution; Precision take the control solution 25ml, 100ml flask, diluted with mobile phase to the scale, shake, as a sensitivity solution. Take about 22mg of fluoxetine hydrochloride, put it in a stopper tube, Add 10ml of 0.5mol/L sulfuric acid solution, water bath at 85°C for 3 hours, and let it cool. The solution contains fluoxetine hydrochloride impurity I and impurity II; take 0.4ml of this solution, put it in a 25ml measuring flask, take fluoxetine hydrochloride about 28mg and impurity IV about 1 mg respectively, put it in the above 25ml measuring flask, add mobile phase to dissolve and dilute to the scale, as a system suitability solution. According to the chromatographic conditions under the item of related substances of fluoxetine hydrochloride, take the applicable solution L01 of the system, inject the human liquid chromatograph, adjust the proportion of mobile phase, and make the retention time of the main component peak 10~18 minutes, the peak order was impurity I, impurity IV, fluoxetine and impurity II (relative retention time was about 0.23,0.94,1.0 and 3.3, respectively), the separation degree between peaks of each component shall meet the requirements. The sensitivity of lOul solution was injected into the liquid chromatograph, and the signal to noise ratio of the main component peak height should be greater than 10. Take 10 u1 of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram to 4 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the chromatographic peaks before the relative retention time of 0.35 shall be subtracted, and the area of a single impurity peak shall not be greater than 1.25 times (0.25%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 4 times (0.8%) of the main peak area of the control solution. 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%). 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).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 15 minutes, take the appropriate amount of crude liquid, filter, take the filtrate as the test solution; Take the appropriate amount of fluoxetine hydrochloride control, precision weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing about 11ug of fluoxetine per 1 ml as a control solution. Accurately measure 20ul of each of the above two solutions, and calculate the dissolution amount of each tablet according to the method under the content measurement item. 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 octanosilane-bonded silica gel as filler (Agilent Zorbax Eclipse Plus C 8,4.6mm X 250mm,5um or equivalent column); buffer solution with triethylamine (take triethylamine 10ml, add water 980ml, shake, adjust pH to 6.0 with phosphoric acid, dilute to 1000ml with water)-methanol-tetrahydrofuran (62:8:30) mobile phase; The detection wavelength was 227nm.
- determination: 10 tablets of this product were placed in a 100ml measuring flask respectively, and the appropriate amount of mobile phase was added. The fluoxetine hydrochloride was dissolved by ultrasound and allowed to cool, as the test solution, the filtrate 10u1 was accurately measured and injected into human liquid chromatograph, and the chromatogram was recorded, add mobile phase to dissolve and quantitatively dilute to prepare about 0.% fluoxetine hydrochloride per 1 ml. llmg solution, the same method. The content of each tablet was calculated by peak area according to external standard method, the result was multiplied by 0.8946, and the average content of 10 tablets was obtained.
category
with fluoxetine hydrochloride.
specification
1Omg (by c17h18f3 no)
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:07:08
Fluoxetine Hydrochloride (200 mg) - Fluoxetlne Hydrochloride Capsules
Authoritative Data Verified Data
This product contains fluoxetine hydrochloride by fluoxetine (c17h18f3 no), should be 90.0% ~ 110.0% of the label amount.
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 an appropriate amount of the contents of this product (about 20mg equivalent to fluoxetine), add 10ml of methanol, fully shake, filter, the filtrate is evaporated on a water bath, and dried at 105°C for 30 minutes, and take the residue, the infrared absorption spectrum of the test article shall be consistent with that of the control (Spectrum set 0402) as determined by infrared spectrophotometry (General rule 837).
- Take appropriate amount of the contents of this product, add appropriate amount of water, fully shake, filter, filtrate chloride identification (1) of the reaction (General 0301).
examination
- Related substances take an appropriate amount of the contents of this product (about 50mg equivalent to fluoxetine), put it in a 25ml measuring flask, add an appropriate amount of mobile phase, shake fully, dilute the mobile phase to the scale, shake and filter, take the continued filtrate as the test solution; Take 5ml of precision measurement, put it in 50ml measuring flask, dilute it with mobile phase to scale, shake well, take 2ml of precision measurement and put it in 100ml measuring flask, dilute with mobile phase to the scale, shake, as a control solution; Precision take the control solution 25ml, 100ml flask, diluted with mobile phase to the scale, shake, as a sensitivity solution. Take about 22mg of fluoxetine hydrochloride, put it in a stopper tube, Add 10ml of 0.5mol/L sulfuric acid solution, water bath at 85°C for 3 hours, and let it cool. The solution contains fluoxetine hydrochloride impurity I and impurity II; take 0.4ml of this solution, put it in a 25ml measuring flask, take fluoxetine hydrochloride about 28mg and impurity IV about 1 mg respectively, put it in the above 25ml measuring flask, add mobile phase to dissolve and dilute to the scale, as a system suitability solution. According to the chromatographic conditions under the items of related substances of fluoxetine hydrochloride, take the applicable solution l0ul of the system, inject the human liquid chromatograph, adjust the proportion of mobile phase, and make the retention time of the main component peak 10~18 minutes, the peak order was impurity I, impurity IV, fluoxetine and impurity II (relative retention time was about 0.23,0.94,1.0 and 3.3, respectively), the separation degree between peaks of each component shall meet the requirements. Take the sensitivity of the solution 10u1 injection liquid chromatography, the signal to noise ratio of the main component peak height should be greater than 10. The sample solution and the control solution were respectively injected into the liquid chromatograph at 10u1, and the chromatogram was recorded to 4 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the chromatographic peaks before the relative retention time of 0.35 shall be subtracted, and the area of a single impurity peak shall not be greater than 1.25 times (0.25%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 4 times (0.8%) of the main peak area of the control solution. 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%). The content uniformity of
- shall be calculated based on the content of each particle measured under the content determination item, and shall comply with the regulations (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 50 rpm, according to the law, after 15 minutes, the appropriate amount of the solution was filtered, and the filtrate was taken as the test solution, water was added to dissolve and quantitatively diluted to prepare a solution containing about 22ug of fluoxetine per 1 ml as a control solution. Respectively, the above two kinds of solutions are accurately absorbed and measured according to the method under the content determination item, the chromatogram is recorded, and the dissolution amount of each particle 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 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 octanosilane bonded silica gel as filler (Agilent Zorbax Eclipse Plus C8,4.6mm X 250mm,5um or equivalent chromatographic column); buffer solution with triethylamine (take triethylamine 10ml, add water 980ml, shake, adjust pH to 6.0 with phosphoric acid, dilute to 1000ml with water)-methanol-tetrahydrofuran (62:8:30) mobile phase; The detection wavelength was 227nm.
- determination Method: Take 10 capsules of this product, transfer the contents to 100ml measuring flask with mobile phase, wash the capsule shell with mobile phase, wash the same measuring flask with washing solution, and fully shake it, dilute to the scale with mobile phase, shake, filter, Take 5ml of filtrate accurately, put it in a 10ml measuring flask, dilute to the scale with mobile phase, shake well, as a test solution, take 10ul precisely, inject human liquid chromatograph, record chromatogram; Take appropriate amount of fluoxetine hydrochloride reference substance, precisely weigh, add mobile phase to dissolve and quantitatively dilute to make about 0 fluoxetine hydrochloride per 1 ml. llmg solution, the same method. The content of each granule was calculated by the peak area according to the external standard method, the result was multiplied by 0.8946, and the average content of 10 granules was obtained.
category
with fluoxetine hydrochloride.
specification
20mg (based on c17h18f3 no)
storability
light shielding, sealed storage.
Last Update：2022-01-01 15:07:09
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View History
Fluoxetine Hydrochloride (200 mg)
1-[4-(苄基)哌嗪-1-基]-2-氯-乙酮
1-(3-(三氟甲基)吡啶-2-基)哌嗪盐酸盐
Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-piperidinylmethyl)-
p-isobutyl-hydratropicacisodiumsalt
1-[4-(苄基)哌嗪-1-基]-2-氯-乙酮
1-(3-(三氟甲基)吡啶-2-基)哌嗪盐酸盐
Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-piperidinylmethyl)-
p-isobutyl-hydratropicacisodiumsalt