Amitriptyline HCl
Amitriptylinehydrochloride
CAS: 549-18-8
Molecular Formula: C20H24ClN
Amitriptyline HCl - Names and Identifiers
| Name | Amitriptylinehydrochloride |
| Synonyms | Amiplin Normaln Amitriptyline HCl AMITRYPTILLINE HCL Amitriptylinehydrochloride Amitriptyline hydrochloride amitriptyline hcl methanol solution Amitriptyline Hydrochloride (200 mg) Amitriptyline hydrochloride solution 3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride |
| CAS | 549-18-8 |
| EINECS | 208-964-6 |
| InChI | InChI=1/C20H23N.ClH/c1-21(2)15-7-12-20-18-10-5-3-8-16(18)13-14-17-9-4-6-11-19(17)20;/h3-6,8-12H,7,13-15H2,1-2H3;1H |
Amitriptyline HCl - Physico-chemical Properties
| Molecular Formula | C20H24ClN |
| Molar Mass | 313.86 |
| Melting Point | 196-197°C |
| Boling Point | 398.2°C at 760 mmHg |
| Flash Point | 11°C |
| Water Solubility | almost transparency |
| Solubility | Easily soluble in water, ethanol, methanol, chloroform, insoluble in ether. |
| Vapor Presure | 1.5E-06mmHg at 25°C |
| Appearance | White to off-white powder |
| Color | white to off-white |
| Merck | 14,487 |
| pKa | 9.4(at 25℃) |
| PH | 4.5～6.0 (10g/l, 25℃) |
| Storage Condition | 2-8°C |
| Sensitive | Sensitive to light |
| MDL | MFCD00012537 |
| Physical and Chemical Properties | This product is white crystalline powder. Melting point 196-197 ℃, soluble in water, ethanol, methanol, chloroform, insoluble in ether. Odorless and bitter. |
| Use | Antidepressants, suitable for all types of depression and organic psychosis depressive symptoms |
| In vitro study | Amitriptyline inhibited Forskolin-stimulated ring AMP aggregation with an EC50 value of 16.2 μm in intact CHO/DOR cells. Amitriptyline concentration-dependently stimulated ERK1/2 and GSK-3β phosphorylation with an EC50 value of 9.0 μm in CHO/DOR cells. Amitriptyline (15 μm) stimulates ERK1/2 phosphorylation in C6 cells. Amitriptyline (30 μm) inhibits Forskolin-stimulated adenylate cyclase activity and antagonizes the inhibitory effect of (−)-U 50,488 in the nucleus accumbens of rats. Amitriptyline binds to the extracellular domains of TrkA and TrkB and promotes TrkA-TrkB receptor heterodimerization. Amitriptyline (< 500 nM) promotes TrkA autophosphorylation in primary neurons and induces neurite outgrowth in PC12 cells. Amitriptyline selectively protects T17 cells from apoptosis with an EC50 of 50 nM. |
| In vivo study | In mice, Amitriptyline (15 mg/kg, I. p.) activates TrkA and TrkB receptors and significantly reduces kainic acid-induced neuronal cell death. Amitriptyline (15 mg/kg and 30 mg/kg, I. p.) dose-dependently reduced immobility time in the forced swimming test (FST) in mice. In the mouse compulsive swimming test (FST), Amitriptyline (15 mg/kg, I. p.) showed a significant 24-h rhythm of immobility time in mice. Amitriptyline (1 mg/kg and 3 mg/kg) significantly increased the total walking distance of mice in the new cage experiment. Amitriptyline (10 mg/kg p.o., twice daily) greatly attenuated the hypothermic response to 8-OHDPAT and mCPP in mice. Amitriptyline (10 mg/kg p.o., twice daily) significantly reduced the serotonin transporter density in the cerebral cortex of mice by approximately 20%. |
Amitriptyline HCl - Risk and Safety
| Risk Codes | R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. R63 - Possible risk of harm to the unborn child R39/23/24/25 - R11 - Highly Flammable R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R36 - Irritating to the eyes R22 - Harmful if swallowed |
| Safety Description | S22 - Do not breathe dust. 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. S61 - Avoid release to the environment. Refer to special instructions / safety data sheets. S60 - This material and its container must be disposed of as hazardous waste. S7 - Keep container tightly closed. |
| UN IDs | UN 2811 6.1/PG 3 |
| WGK Germany | 3 |
| RTECS | HO9450000 |
| TSCA | Yes |
| HS Code | 29214990 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in mice, rats (mg/kg): 350, 380 orally; 65, 75 i.p. (Tobe) |
Amitriptyline HCl - Reference
| Reference Show more | 1. [IF=5.909] Xi He et al."One-pot synthesis of C-doping and defects co-modified g-C3N4 for enhanced visible-light photocatalytic degradation of bisphenol A."J Environ Chem Eng. 2021 Dec;:106911 |
Amitriptyline HCl - Standard
Authoritative Data Verified Data
This product is N, n-dimethyl-3-[10,ll-dihydro-5h-dibenzo [a,d] cycloheptatrien-5-subunit]-1-propylamine hydrochloride. The content of C20H23N • HCl shall not be less than 99.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
Amitriptyline HCl - Trait
Authoritative Data Verified Data
- This product is colorless crystal or white, white powder; Odorless or almost odorless.
- This product is soluble in water, methanol, ethanol or chloroform, and almost insoluble in ether.
melting point
The melting point of this product (General rule 0612 first method) is 195~199°C.
Last Update：2022-01-01 15:05:15
Amitriptyline HCl - Introduction
Amitriptyline inhibits serotonin receptor, norepinephrine receptor, 5-HT4, 5-HT2 and sigma 1 receptor with IC50 of 3.45 nM, 13.3 nM, 7.31 nM, 235 nM and 287 nM, respectively.
Last Update：2022-10-16 17:26:13
Amitriptyline HCl - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add 2ml sulfuric acid to dissolve, the solution shows red.
- take this product, add hydrochloric acid solution (9-1000) to dissolve and dilute to prepare a solution containing 12ug per lml, and measure by UV-visible spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 239nm, and the absorbance is 0.51 to 0.56.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 360).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:05:15
Amitriptyline HCl - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.5~6.0.
clarity and color of solution
take 0.20g of this product, Add 10ml of water to dissolve, the solution should be clear and colorless. In case of color development, it shall not be deeper in comparison with the standard colorimetric solution of Yellow No. 2 or orange No. 2 (General rule 0901 method 1).
Related substances
take this product, add mobile phase to dissolve and dilute to make a solution containing 0.2mg per 1 ml as a test solution; Take appropriate amount with precision, A solution containing 2ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the test of high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as filler; Methanol-water-triethylamine (60:40:0.3)(pH was adjusted to 3.1 with phosphoric acid) mobile phase; The detection wavelength was 240mn. The number of theoretical plates shall not be less than 3000 calculated as the peak of amitriptyline. The control solution and the test solution were respectively injected with human liquid chromatography, 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 area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
residual solvent
take an appropriate amount of this product, accurately weigh, add dimethylformamide to dissolve and dilute to make a solution containing about 20mg per lml, as a test solution; Take toluene, tetrahydrofuran and isopropanol, precision weighing, diluted with dimethylformamide to prepare a mixed solution containing about 17.8ug of toluene, 14.4ug of tetrahydrofuran and 100ug of isopropyl alcohol per 1 ml, as a reference solution. According to the test for determination of residual solvents (General Principle 0861 third method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column; The initial temperature is 80°C, the temperature was maintained for 10 minutes, and the temperature was increased to 200°C at a rate of 20°C per minute for 5 minutes; The inlet temperature was 250°C; And the detector temperature was 250°C. Take the reference solution lul and inject it into the human gas chromatograph, and the separation degree between peaks of each component shall meet the requirements; Then take 1ul of each sample solution and the reference solution, and inject the human gas chromatograph separately, record the chromatogram and calculate the peak area according to the external standard method. The residual amount of toluene, tetrahydrofuran and isopropanol shall meet the requirements.
loss on drying
take this product, with phosphorus pentoxide as desiccant, at 60°C under reduced pressure drying to constant weight, weight loss should not exceed 0.5% (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 ignition residue item shall not contain more than 15 parts per million of heavy metals as inspected by law (General rule 0821, Law II).
Last Update：2022-01-01 15:05:16
Amitriptyline HCl - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add glacial acetic acid 10ml and acetic anhydride 20ml to dissolve, according to the potential titration method (General rule 0701), 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 31.39mg of c20 h23n-HCL.
Last Update：2022-01-01 15:05:17
Amitriptyline HCl - Category
Authoritative Data Verified Data
antidepressants.
Last Update：2022-01-01 15:05:17
Amitriptyline HCl - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:05:17
Amitriptyline HCl - Amitriptyline Hydrochloride Tablets
Authoritative Data Verified Data
This product contains amitriptyline hydrochloride (C20H23N • HCI) should be labeled the amount of 90.0% to 110.0%.
trait
This product is sugar-coated tablet or film-coated tablet, White after removing the coating.
identification
- the solution under the item of dissolution was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of Nm.
- take 1 tablet of this product, grind it, add 4ml of water, shake it, filter it, add 2 drops of dilute nitric acid to the filtrate, and add 2 drops of silver nitrate test solution to generate white precipitate.
examination
- relevant substances: take an appropriate amount of the fine powder of this product, add the mobile phase to dissolve and dilute to prepare a solution containing 0.2mg of amitriptyline hydrochloride per 1 ml as the test solution; Take an appropriate amount for precision measurement, A solution containing 2ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. If there are impurity peaks in the chromatogram of the sample solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate according to law, after 45 minutes, take 10ml of solution, filter, take 5ml of filtrate accurately, put it in a 10ml measuring flask, dilute it to scale with dissolution medium, shake well, the absorbance was measured at a wavelength of 239mn according to ultraviolet-visible spectrophotometry (General 0401), and the elution amount per tablet was calculated as the absorption coefficient of C20H23N. HC1 was 444. The limit is 75% 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 eighteen alkyl silane bonded silica gel as filler; Methanol-water-triethylamine (60:40:0.3)(pH adjusted to 3.1 with phosphoric acid) mobile phase; The detection wavelength was 240mn. The number of theoretical plates shall not be less than 3000 calculated as the peak of amitriptyline.
- determination: 20 tablets of amitriptyline hydrochloride (sugar-coated tablets to remove coating) were accurately weighed and placed in a 200ml measuring flask, and the mixture was shaken with an appropriate amount of mobile phase to dissolve amitriptyline hydrochloride and diluted to the scale, filtration, precise amount of filtrate, diluted with mobile phase to make a solution containing about 0.02mg per lml, precise amount of 10u1 injection of human liquid chromatography, record chromatogram; Another amount of amitriptyline hydrochloride reference, the mobile phase was added and dissolved and diluted to prepare a solution containing about 0.02mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category storage
with amitriptyline hydrochloride.
specification
25mg
Last Update：2022-01-01 15:05:18
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