Bupropion (hydrochloride) (CRM)
bupropion hydrochloride
CAS: 31677-93-7;31667-93-7
Molecular Formula: C13H18ClNO.HCl
Bupropion (hydrochloride) (CRM) - Names and Identifiers
| Name | bupropion hydrochloride |
| Synonyms | bupropionhcl Bupropion HCl Bupropion Impurity 1 bupropion hydrochloride Bupropion Hydrochloride Bupropion, Hydrochloride Amfebutamone hydrochloride Bupropion hydrochloride salt Bupropion hydrochloride, 100ppm Bupropion (hydrochloride) (CRM) 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one 2-(t-Butylamino)-3'-chloropropiophenone hydrochloride 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one HCl (2S)-N-tert-butyl-1-(3-chlorophenyl)-1-oxopropan-2-aminium chloride |
| CAS | 31677-93-7 31667-93-7 |
| EINECS | 250-759-9 |
| InChI | InChI=1/C13H18ClNO.ClH/c1-9(15-13(2,3)4)12(16)10-6-5-7-11(14)8-10;/h5-9,15H,1-4H3;1H/t9-;/m0./s1 |
Bupropion (hydrochloride) (CRM) - Physico-chemical Properties
| Molecular Formula | C13H18ClNO.HCl |
| Melting Point | 233-234° |
| Boling Point | 334.8°C at 760 mmHg |
| Flash Point | 9°C |
| Water Solubility | Soluble in water (>25 mg/ml), ethanol 193mg/ml, 0.1 N HCl 333 mg/ml |
| Solubility | Soluble in DMSO (40 mg/ml) |
| Vapor Presure | 0.000125mmHg at 25°C |
| Appearance | solid |
| Color | white |
| Merck | 14,1499 |
| pKa | 7.9(at 25℃) |
| Storage Condition | 2-8°C |
| Stability | Stable for 2 years from date of purchase as supplied. Solutions in DMSO may be stored at -20°C for up to 3 months. |
| Physical and Chemical Properties | Melting point 233-234°C |
| Use | This product is the central nervous system drugs. |
Bupropion (hydrochloride) (CRM) - Risk and Safety
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 3 |
| RTECS | UG8858000 |
| HS Code | 2923900100 |
| Toxicity | LD50 in mice, rats (mg/kg): 230, 210 i.p.; 575, 600 orally (Soroko) |
Bupropion (hydrochloride) (CRM) - Standard
Authoritative Data Verified Data
This product is (±) -2-tert-butylamino-3 '-chlorophenylacetone hydrochloride. The content of C13H18ClNO • HC1 shall not be less than 99.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
Bupropion (hydrochloride) (CRM) - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder.
- This product is soluble in water, methanol or ethanol, and almost insoluble in ethyl acetate.
Last Update：2022-01-01 15:04:18
Bupropion (hydrochloride) (CRM) - Differential diagnosis
Authoritative Data Verified Data
- take an appropriate amount of this product and add water to make a solution containing about 10ug per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at the wavelength of 251mn and 299nm, and a minimum absorption at the wavelength of 227nm and 278nm.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:04:19
Bupropion (hydrochloride) (CRM) - Exam
Authoritative Data Verified Data
acidity
take 0.5g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 4.0~6.0.
clarity and color of solution
take 0.5g of this product and add 20ml of water to dissolve, 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 shall not be deeper in comparison with the yellow No. 1 Standard Colorimetric solution (General rule 0901 first method).
bromide
take this product l. Add 10ml of water to dissolve, add 3 drops of hydrochloric acid and lml of chloroform, while shaking, add 3 drops of 2% chloramine T solution (freshly prepared), if the chloroform layer is colored, 105 with standard potassium bromide solution (accurately weigh 0.1489g of potassium bromide dried at 1.0°C to constant weight, add appropriate amount of water to dissolve and make 100ml, shake well), the comparison of the control solution prepared by the same method should not be deeper (0.1%).
Related substances
take an appropriate amount of this product, add 50% methanol to dissolve and dilute to prepare a solution containing about 1 mg per 1ml as a test solution; Take 1ml for precision measurement and put it in a 200ml measuring flask, as a control solution, it was diluted to the scale with 50% methanol and shaken. Take 1ml of the control solution, put it in a 10ml measuring flask, dilute it to the scale with 50% methanol, and shake it to be used as a sensitivity solution. The appropriate amount of 3-chlorophenylacetone (impurity I) control and Bupropion hydrochloride was dissolved in 50% methanol and diluted to prepare a solution containing about 10ug of impurity I and 1 mg of bupropion hydrochloride per 1ml as the system applicable solution. According to the test of high performance liquid chromatography (General 0512), octyl silane bonded silica gel is used as the filler; 0.025mol/L potassium dihydrogen phosphate solution (adjust pH value to 7.0 with 1 mol/L sodium hydroxide solution)-Methanol-tetrahydrofuran (51:39:11) as mobile phase; Detection wavelength was 250mn. Take the system applicable solution 10u1 injection liquid chromatograph, the separation degree between impurity I and bupropion peak should be greater than 7. Take the sensitivity of the solution 10 A injection of liquid chromatography, the main component of the peak signal to noise ratio should be greater than 10. The sample solution and the control solution were respectively injected with 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 the area of the main peak of the control solution (0.5% ) , the sum of each impurity peak area shall not be greater than 2 times (1.0%) 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.
residual solvent
take this product about 0.5g, precision weighing, top empty bottle, precision plus 50% N,N-dimethylformamide solution 5ml to dissolve, sealed, as a test solution; in addition, the appropriate amount of acetonitrile, dichloromethane and trichloromethane was carefully weighed and diluted with 50% N,N-dimethylformamide solution to make about 41 acetonitrile mesh per 1 ml, respectively, the mixed solution of 60 tons of dichloromethane and 6ug of trichloromethane was accurately measured and 5ml 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, it was maintained for 5 minutes and heated to 200°C at a rate of 20°C per minute for 1 minute; The inlet temperature was 200°C and the detector temperature was 260°C. The Headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree of each component should meet the requirements. The test solution and the reference solution were injected with headspace, and the chromatograms were recorded. According to the external standard method to calculate the peak area, acetonitrile, dichloromethane and chloroform residues should be in accordance with the provisions.
loss on drying
take l.Og of this product, dry to constant weight at 105°C, and lose no more than 0.5% of weight (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:04:20
Bupropion (hydrochloride) (CRM) - Content determination
Authoritative Data Verified Data
take this product about 0.2g, precision weighing, add glacial acetic acid 20ml and acetic anhydride 10ml dissolved, according to the potential titration method (General rule 0701), with perchloric acid titration solution (0.1 mol/L) titration, and the titration results were corrected with a blank test. Each 1 ml perchloric acid titration solution (0.1 mol/L) corresponds to 27.62mg of C13H18C1N0. HCl.
Last Update：2022-01-01 15:04:20
Bupropion (hydrochloride) (CRM) - Category
Authoritative Data Verified Data
antidepressants.
Last Update：2022-01-01 15:04:21
Bupropion (hydrochloride) (CRM) - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:04:21
Bupropion (hydrochloride) (CRM) - Bupropion hydrochloride
Authoritative Data Verified Data
This product contains bupropion hydrochloride (C13H18C1N0 • HCl) should be 93.0% ~ 107.0% of label amount.
trait
This product is a film-coated tablet, white or off-white after removal of the coating.
identification
- take the control solution under the item of related substances as the test solution; Take an appropriate amount of bupropion hydrochloride reference, add methanol to dissolve and dilute to make a solution containing about 5ug per 1 ml, as a reference solution, it was measured according to the chromatographic conditions under the item of related substances. 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.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at wavelengths of NM and Nm.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- Related Substances: take an appropriate amount of fine powder of this product, weigh it accurately, dissolve it with 50% methanol and dilute it to make a solution containing about 1 mg per 1ml, which is used as a test solution; Take 1ml for precision measurement, set in a 50% measuring flask, dilute to the mark with methanol, and shake well to serve as a control solution. An appropriate amount of the reference substance of bupropion hydrochloride impurity n was accurately weighed, dissolved in 50% methanol and quantitatively diluted to prepare a solution containing 1ml as a reference solution. Take 1ml of the control solution, put it in a 10ml measuring flask, dilute it to the scale with 50% methanol, and shake it to be used as a sensitivity solution. The appropriate amounts of bupropion hydrochloride impurity I and Bupropion hydrochloride are taken respectively, dissolved in 50% methanol and diluted to prepare a solution containing about 1 ug of impurity I and 1 mg of bupropion hydrochloride per 1ml as a system-applicable solution. According to bupropion hydrochloride related substances determination method. The sample solution, the reference solution and the control solution were respectively injected with human liquid chromatography, and the chromatogram was recorded to 3 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 the main peak of the reference solution, the peak area shall be calculated according to the external standard method, and 0.5% of the labeled amount of bupropion hydrochloride shall not be exceeded; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.5% ), and the total amount of impurities shall not exceed 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.
- 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 30 minutes, take an appropriate amount of the solution, filter, take a precise amount of 3ml of the filtrate, put it in a 25ml measuring flask, dilute it with water to the scale, shake it well, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 252nm, water was added to dissolve and quantitatively diluted to prepare a solution containing about 10ug per 1 ml, which was determined by the same method. The dissolution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about 50mg equivalent to bupropion hydrochloride), put in 250ml measuring flask, add appropriate amount of water, ultrasonic dissolution of bupropion hydrochloride, dilute to the scale with water, shake, filter, Take 5ml of filtrate accurately, put it in a 100ml measuring flask, dilute to the scale with water, shake well, as a test solution, measure the absorbance at the wavelength of 252mn according to UV-Vis spectrophotometry (General rule 0401); Accurately weigh appropriate amount of bupropion hydrochloride reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about lOug per 1 ml, which was determined and calculated by the same method.
category
with bupropion hydrochloride.
specification
75mg
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:04:23
Bupropion (hydrochloride) (CRM) - Bupropion Hydrochloride Sustain Release Tablets
Authoritative Data Verified Data
This product contains bupropion hydrochloride (C13H18ClNO • HCl) 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
- take the control solution under the item of related substances as the test solution; Take an appropriate amount of bupropion hydrochloride control, add 50% methanol to dissolve and dilute to prepare a solution containing about 5ug per 1 ml, as a reference solution, test under the chromatographic conditions under the item of related substances. 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.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at wavelengths of NM and Nm.
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
examination
- Related Substances: take an appropriate amount of fine powder of this product, weigh it accurately, dissolve it with 50% methanol and dilute it to make a solution containing about 1 mg per 1ml, which is used as a test solution; Take 1ml for precision measurement, in a 200ml measuring flask, dilute to the scale with 50% methanol, shake well, and use as a control solution. Take an appropriate amount of bupropion hydrochloride impurity II reference, and weigh it precisely, A solution containing about 12ug per 1ml was prepared by dissolving and quantitatively diluting with 50% methanol as a control solution. Take 1ml of the control solution, put it in a 10ml measuring flask, dilute it to the scale with 50% methanol, and shake it to be used as a sensitivity solution. The appropriate amounts of bupropion hydrochloride impurity I and Bupropion hydrochloride are taken, dissolved in 50% methanol and diluted to prepare a solution containing about lOug of impurity I and 1 mg of bupropion hydrochloride per 1ml as a system applicable solution. According to the method for the determination of bupropion hydrochloride related substances, the sample solution, the reference solution and the control solution were respectively 10ul, and the human liquid chromatograph was injected respectively, the chromatogram was recorded to 3 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 the main peak of the reference solution, the peak area shall be calculated according to the external standard method, and 1.2% of the labeled amount of bupropion hydrochloride shall not be exceeded; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.5% ) , and the sum of the peak areas of other impurities shall not be greater than 2 times (1.0%) 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.
- 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 1 hour, 4 hours and 8 hours, take 10ml of the solution respectively, filter, and immediately add the dissolution medium of the same temperature and the same volume in the dissolution Cup, and take 5ml of the continued filtrate in a precise amount, put 50ml measuring flask, dilute to the scale with water, shake well, measure the absorbance at the wavelength of 2 5 2 n m respectively according to ultraviolet-visible spectrophotometry (General rule 0401); in addition, an appropriate amount of bupropion hydrochloride reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 10ug per lml, which was determined by the same method. The dissolution amount of each tablet at different times was calculated separately. The dissolution amount of each tablet at 1 hour, 4 hours and 8 hours shall be 20% ~ 40%, 45% ~ 70% and more than 75% of the labeled amount, and shall be in accordance with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 50mg equivalent to bupropion hydrochloride), put it in a 250ml measuring flask, add an appropriate amount of water, immediately and fully shake, add appropriate amount of water, heat at 40°C in water bath to dissolve bupropion hydrochloride, cool, dilute with water to scale, shake well, filter, Take 5ml of continued filtrate, put it in 100ml measuring flask, dilute with water to the scale, shake, as a test solution, according to UV-visible spectrophotometry (General 0401), at the wavelength of 252nm absorbance; in addition, an appropriate amount of bupropion hydrochloride reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 10ug per lml, which was determined and calculated by the same method.
category
with bupropion hydrochloride.
specification
0.15g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:04:24
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Product Name: Bupropion Hydrochloride Visit Supplier Webpage Request for quotationCAS: 31677-93-7
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Product Name: bupropion hydrochloride Request for quotation
CAS: 31677-93-7
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 31677-93-7
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
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