DL-4-Amino-3-p-chlorophenylbutanoic acid
Baclofen
CAS: 1134-47-0
Molecular Formula: C10H12ClNO2
DL-4-Amino-3-p-chlorophenylbutanoic acid - Names and Identifiers
DL-4-Amino-3-p-chlorophenylbutanoic acid - Physico-chemical Properties
| Molecular Formula | C10H12ClNO2 |
| Molar Mass | 213.66 |
| Density | 1.2069 (rough estimate) |
| Melting Point | 208-210°C |
| Boling Point | 364.3±32.0 °C(Predicted) |
| Flash Point | 174.1°C |
| Water Solubility | Soluble in dilute NaOH or dilute HCl. Soluble in water at approximately 4mg/ml at pH 7.6 |
| Solubility | 1 M HCl: 50mg/mL |
| Vapor Presure | 6.01E-06mmHg at 25°C |
| Appearance | solid |
| Color | white to very faintly yellow |
| Merck | 14,937 |
| pKa | pKa 3.87±0.1(H2O) (Uncertain) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.5500 (estimate) |
| Physical and Chemical Properties | Melting Point: 189 - 191 water-soluble:<0.1g/100 mL at 18 C Appearance: white crystal powder |
| Use | Used as a spinal cord muscle relaxant, sedative |
DL-4-Amino-3-p-chlorophenylbutanoic acid - Risk and Safety
| Risk Codes | R61 - May cause harm to the unborn child R25 - Toxic if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. S22 - Do not breathe dust. 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.) S52 - Not recommended for interior use on large surface areas. S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | MW5084200 |
| HS Code | 2922492050 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in male mice, rats (mg/kg): 45, 78 i.v.; 103, 115 s.c.; 200, 145 orally (Tadokoro) |
DL-4-Amino-3-p-chlorophenylbutanoic acid - Standard
Authoritative Data Verified Data
This product is B- (aminomethyl)-4-chloro-hydrocinnamic acid. The content of C10H12ClNO2 shall not be less than 99.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
DL-4-Amino-3-p-chlorophenylbutanoic acid - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is slightly soluble in water, very slightly soluble in methanol, insoluble in chloroform; Slightly soluble in dilute acid or dilute alkali.
Last Update：2022-01-01 11:33:02
DL-4-Amino-3-p-chlorophenylbutanoic acid - Differential diagnosis
Authoritative Data Verified Data
- take the test solution under the item of related substances as the test solution; Take an appropriate amount of baclofen reference substance and add diluent (take methanol 75ml and glacial acetic acid 10ml, dilute to 250ml with water) dissolve and dilute to make a solution containing about 4mg per 1 ml as a control solution. According to the chromatographic conditions under the item of related substances, 10ul of each of the above two solutions is injected into the human liquid chromatograph respectively, and the chromatogram is recorded. 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.
- take this product, add water to dissolve and dilute to make a solution containing about 0401 mg per lml, according to UV-visible spectrophotometry (general rule), at 259nm, there is a maximum absorption at the wavelength of 266nm and 275nm, and a minimum absorption at the wavelength of 272nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 701).
Last Update：2022-01-01 11:33:03
DL-4-Amino-3-p-chlorophenylbutanoic acid - Exam
Authoritative Data Verified Data
Related substances
take this product, precision weighing, add diluent (take methanol 75ml and glacial acetic acid 10ml, dilute to 250ml with water) dissolve and quantitatively dilute to make a solution containing about 4mg per 1 ml, as a test solution; An appropriate amount was taken in a precise amount, and diluted quantitatively with a diluent to prepare a solution containing about 8UG and 2ug per 1 ml as a control solution and a sensitivity solution. Additionally, the reference substance of impurity I was precision weighed, dissolved with methanol and quantitatively diluted to prepare a solution containing about 1 ml per 1 ml, which was used as a reference solution. According to the high performance liquid chromatography method (General rule 0512) test, using eighteen alkyl silane bonded silica gel as filler (4.6mm x mm,5um or equivalent column), the mobile phase was 0.3mol/L glacial acetic acid solution-methanol -0.36mol/L sodium pentanesulfonate solution (550:440:20), and the detection wavelength was 265nm, the resolution between baclofen peak and impurity I peak should meet the requirements. Inject the sensitive solution lOul into the liquid chromatograph and record the chromatogram. The signal-to-noise ratio of baclofen peak should be greater than 10, they were injected into the liquid chromatograph, and the chromatogram was recorded 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, the peak area shall be calculated according to the external standard method, and shall not exceed 1.0%; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (0.2% ) ; The total amount of impurities shall not exceed 2.0%. The peak less than the main peak area of the sensitivity solution in the chromatogram of the test solution is negligible (0.05%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (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 0.2%.
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 11:33:03
DL-4-Amino-3-p-chlorophenylbutanoic acid - Content determination
Authoritative Data Verified Data
take this product about 0701 mg, precision weighing, add glacial acetic acid 20ml dissolution, according to the potential titration method (general rule), 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 21.37mg of C10H12C1N02.
Last Update：2022-01-01 11:33:04
DL-4-Amino-3-p-chlorophenylbutanoic acid - Category
Authoritative Data Verified Data
Central muscle relaxants.
Last Update：2022-01-01 11:33:04
DL-4-Amino-3-p-chlorophenylbutanoic acid - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:33:04
DL-4-Amino-3-p-chlorophenylbutanoic acid - Baclofen tablets
Authoritative Data Verified Data
This product contains baclofen (C10H12CIN02) should be 90.0% -110.0% of the label.
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 control solution.
examination
- for related substances, take the test solution under the content determination item as the test solution; Respectively, take appropriate amount of precise amount, and use diluent (methanol 75ml and glacial acetic acid 10ml, dilute with water to 250ml, Shake) quantitative dilution to prepare solutions containing about 20UG and 2ug of baclofen per 1 ml as control solution and sensitivity solution. In addition, the reference substance of impurity I was accurately weighed, dissolved in methanol and quantitatively diluted to prepare a solution containing about 80/zg in 1 ml as a reference solution. According to the chromatographic conditions under the content determination item, the sensitivity solution 10M1 is injected into the liquid chromatograph, and the chromatogram is recorded. The signal-to-noise ratio of baclofen peak should be greater than 10, the control solution and the reference solution were injected into the liquid chromatograph respectively, and the chromatogram was recorded to 4 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall be calculated by external standard method, and 2.0% of the labeled amount of baclofen 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 4 times (2.0%) of the main peak area of the control solution. The peak less than the main peak area of the sensitivity solution in the chromatogram of the test solution is negligible (0.05%).
- Content uniformity: Take 1 tablet of this product, place it in a test tube, and measure it according to the method under the item of content determination, in which the concentration of the reference solution is diluted into a solution containing 1 mg per l M, the provisions shall be met (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, and the operation is carried out according to law. After 30 minutes, 10ml of the solution is taken, filtered, and the chromatographic conditions under the item of content determination are taken, the continuous filtrate 50 u1 was accurately measured, and the liquid chromatograph was injected. The chromatogram was recorded. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 20ug per 1 ml, which was used as a reference solution and was measured by the same method. According to the external standard method, the dissolution amount of each tablet is calculated by the peak area, and the limit is 80% of the labeled amount, which 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 (4.6mm X 250mm, 5um or performance equivalent column); the mobile phase was 0.3mol/L glacial acetic acid solution-methanol -0.36mol/L sodium pentanesulfonate solution (550:440:20), and the detection wavelength was 265mn. The number of theoretical plates shall not be less than 1500 calculated by Baclofen peak, and the separation degree between baclofen peak and adjacent peaks shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision taking an appropriate amount (equivalent to Baclofen 40mg), put in the test tube, add human dilution solution (methanol 75ml and glacial acetic acid 10ml, dilute to 250ml with water, shake well) 10ml, ultrasonic dissolve baclofen, centrifuge for 20 minutes, take the supernatant as test solution, lOul was accurately measured and injected into human Liquid Chromatograph. The chromatogram was recorded. According to the external standard method to calculate the peak area, that is.
category
Same as baclofen.
specification
10mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:33:05
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CAS: 1134-47-0
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CAS: 1134-47-0
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