Takkmint
Trimetazidine HCL
CAS: 13171-25-0
Molecular Formula: C14H24Cl2N2O3
Takkmint - Names and Identifiers
| Name | Trimetazidine HCL |
| Synonyms | Takkmint Vastarel F Yoshimilon Youmetazine Trimetazidine HCL Trimetazidine 2HCl Trimetazidine 3HCl Trimetazidine Dihydrochloride 1-(2,3,4-trimethoxybenzyl)piperazine 1-(2,3,4-trimethoxybenzyl)piperazinediium 1-(2,3,4-trimethoxybenzyl)piperazine dihydrochloride 1-(2,3,4-TRIMETHOXYBENZYL)PIPERAZINE DIHYDROCHLORIDE 1-[(2,3,4-Trimethoxy-phenyl)methyl]piperazine Dihydrochloride 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride,Trimetazidine dihydrochloride |
| CAS | 13171-25-0 |
| EINECS | 236-117-0 |
| InChI | InChI=1/C14H22N2O3/c1-17-12-5-4-11(13(18-2)14(12)19-3)10-16-8-6-15-7-9-16/h4-5,15H,6-10H2,1-3H3/p+2 |
| InChIKey | XIRALXKCBGTYSC-UHFFFAOYSA-N |
Takkmint - Physico-chemical Properties
| Molecular Formula | C14H24Cl2N2O3 |
| Molar Mass | 339.26 |
| Melting Point | 231-235°C(lit.) |
| Boling Point | 364°C at 760 mmHg |
| Flash Point | 174°C |
| Solubility | Freely soluble in water, sparingly soluble in alcohol. |
| Vapor Presure | 1.73E-05mmHg at 25°C |
| Appearance | neat |
| Color | White to Off-White |
| Merck | 14,9705 |
| Storage Condition | Refrigerator |
| Stability | Hygroscopic |
| In vitro study | Trimetazidine upregulates the expression of miR-21, and miR12 targets PTEN and promotes PI3K signaling pathway, thus hindering the apoptotic effect brought about by hypoxia/reperfusion. |
| In vivo study | In the heart of wild-type C57BL/6J mice, treatment with TMZ(Trimetazidine) reduced the area of myocardial infarction. Both AMPK and ERK signaling pathways mediate and participate in the Myocardial Protection of TMZ against ischemic injury of the heart. Trimetazidine converts fatty acid oxidation metabolism to glucose oxidation metabolism and improves the contractile function of cardiomyocytes under hypoxic conditions. |
Takkmint - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| WGK Germany | 3 |
| RTECS | TM2976100 |
| HS Code | 29339900 |
| Hazard Class | IRRITANT |
| Toxicity | LD50 in male, female mice, rats (mg/kg): 91, 107, 124, 124 i.v.; 264, 245, 327, 288 i.p.; 528, 608, 1147, 987 orally (Harpey) |
Takkmint - Standard
Authoritative Data Verified Data
This product is l- (2,3, 4-trimethoxybenzyl) piperazine dihydrochloride. The content of C14H22N203 • 2HC1 shall be between 98.0% and 102.0% calculated as dry.
Last Update：2024-01-02 23:10:35
Takkmint - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is very soluble in water, soluble in glacial acetic acid, soluble in methanol, slightly soluble in ethanol, almost insoluble in ether; In 0.1 mol/ L hydrochloric acid solution or 0.lmol/ L sodium hydroxide solution is very soluble.
Last Update：2022-01-01 14:22:57
Takkmint - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add 1ml of water to dissolve, add 1% of p-benzoquinone ethanol solution (take 1, 4-benzoquinone lg, add 5ml of glacial acetic acid to dissolve, add ethanol to lOOml)1ml was heated, boiled for 2-3 minutes, and allowed to cool. The Solution turned red.
- take this product, add 0.1 mol/ L hydrochloric acid solution was dissolved to prepare a solution containing 20ug per 1 ml, and the maximum absorption was measured by ultraviolet-visible spectrophotometry (General 0401) at a wavelength of Nm.
- 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 14:22:58
Takkmint - Exam
Authoritative Data Verified Data
acidity
take 0.50g of this product, Add 10ml of water to dissolve, and determine according to law (General rule 0631), the pH value should be 2.3~3.3.
clarity and color of solution
take 0.5g of this product and add 5ml of water to dissolve the solution. 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), it shall not be deeper in comparison with the yellow No. 1 Standard Colorimetric solution (General rule 0901 first method).
Related substances
take 0.2g of this product, put it in a 50ml measuring flask, add water to dissolve and dilute to the scale, shake well, and use it as a test solution, in a 100ml measuring flask, dilute to the scale with water, shake well, take 1ml precisely, put it in a 10ml measuring flask, dilute to the scale with water, shake well, as a control solution; 1ml of the control solution was accurately measured and placed in a 10ml measuring flask, diluted with water to the scale, and shaken to obtain a sensitivity solution. Octadecyl silicone-bonded silica gel was used as a filler (0512 X 4.6mm, 5uM) as tested by high performance liquid chromatography (General Document 1). The mobile phase A was 0.287% anhydrous sodium heptane sulfonate solution-methanol (643:357), adjusted to pH 10% with 3.0 phosphoric acid, and the mobile phase B was methanol, and the gradient elution was carried out according to the following table, and the detection wavelength was 240mn. Take about 20mg of trimetazidine hydrochloride control, add 2ml of water to dissolve, add 3ml of 30% hydrogen peroxide solution, shake, 25~35°C for 1~2 hours (Control of oxidative degradation of impurities is about 2% ) , as the system applicable solution, take 10u1 injection liquid chromatograph, chromatogram ^ retention time of trimetazidine peak is about 30 minutes, relative retention time of oxidative degradation impurity peak is about 0.95, the separation degree of the oxidative degradation impurity peak from the main peak and its adjacent impurity peaks shall meet the requirements. Take 10ul sensitivity solution, injection liquid chromatography, the signal to noise ratio of the main component peak should not be less than 10. Then, 10 u1 of the test solution and 10 u1 of the control solution are respectively accurately measured and injected into the liquid chromatograph to record the chromatogram. 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 (0.2% ) , the sum of each impurity peak area shall not be greater than 2.5 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 (0.02%).
palazine
take this product, weigh it precisely, add methanol to dissolve and dilute quantitatively to make a solution containing lOmg per lml as a test solution; Take piperazine Hexahydrate (C4H10N2 • 6H20 ), methanol was added to dissolve and quantitatively diluted to prepare a solution containing 22.6ug per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel G thin layer plate, with ethanol-concentrated ammonia solution (80:20) for development, it was developed, taken out, dried, dried at 105 ° C. For 30 minutes, and sprayed with platinum iodide solution (0.3% chlorocapsule hexahydrate solution was mixed with 6% potassium iodide solution by equal volume). If the test solution shows impurity spots corresponding to the control solution, the color of the test solution should not be deeper than the main spot of the control solution (0.1%, based on anhydrous piperazine).
residual solvent
take an appropriate amount of this product, weigh it accurately, add water to dissolve it and make it contain 0.lg of the solution, as a test solution; Precision weighing anhydrous ethanol, dichloromethane, chloroform and toluene, diluted with water to make each 1 ml containing about 0.5mg, 0.06mg, A mixed solution of 0.006mg and 0.089mg was used as a control solution. 5ml of each of the test solution and the reference solution were accurately measured, respectively placed in the headspace bottle and sealed. According to the test for determination of residual solvents (General Principle 0861 second method), the capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane as stationary liquid is used as the column; The temperature is increased by program, and the initial temperature is 60°C, which is maintained for 6 minutes, the temperature was raised to 180°C at a rate of 10°C per minute for 1 minute; The headspace bottle equilibration temperature was 60°C and the equilibration time was 45 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree of each component peak shall meet the requirements. Then the sample solution and the reference solution were sampled by Headspace respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, ethanol, dichloromethane, chloroform and toluene 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 1.5% (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 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).
arsenic salt
take l.Og of this product, add 23ml of water to dissolve, add 5ml of hydrochloric acid, check according to law (General rule 0822 first law), should comply with the provisions (0.0002%).
Last Update：2022-01-01 14:22:59
Takkmint - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as A filler, and mobile phase A- mobile phase B(80:20) under the item of related substances was used as A mobile phase, and the detection wavelength was 231nm. The number of theoretical plates shall not be less than 3000 based on the calculation of trimetazidine peak, and the separation degree between trimetazidine peak and adjacent impurity peaks shall meet the requirements.
assay
take about 0.lg of this product, accurately weigh it, put it in a 100ml measuring flask, add appropriate amount of water to dissolve and dilute to the scale, shake well, take 5ml of precision measurement, put it in a 25ml measuring flask, dilute to scale with water, shake well, inject 10ul into liquid chromatograph with precision, record chromatogram. In addition, an appropriate amount of trimetazidine hydrochloride reference substance was determined by the same method and calculated by peak area according to external standard method.
Last Update：2022-01-01 14:22:59
Takkmint - Category
Authoritative Data Verified Data
anti-anginal drugs.
Last Update：2022-01-01 14:23:00
Takkmint - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 14:23:00
Takkmint - Trimetazidine Dihydrochloride Tablets (VASOREL)
Authoritative Data Verified Data
This product contains trimetazidine hydrochloride (C14H22N203 • 2HC1) should be 95.0% ~ 105.0% of the label.
trait
This product is a film-coated tablet, white or off-white after removal of the coating.
identification
- take an appropriate amount of the fine powder of this product (about 10 mg of trimetazidine hydrochloride), add 5ml of water, shake to dissolve trimetazidine hydrochloride, filter, and take 1ml of filtrate, according to the test of item (1) under the identification of trimetazidine hydrochloride, the same reaction was shown.
- take an appropriate amount of fine powder of this product and add 0. The lmol / L hydrochloric acid solution is made into a solution containing 20ug of trimetazidine hydrochloride per lm], filtered and irradiated by UV-Vis spectrophotometry (determination by General rule 0401), there is an absorption maximum at a wavelength of 231nm.
- take the product, remove the coating, grind it fine, weigh an appropriate amount of fine powder (about equivalent to trimetazidine hydrochloride lOOmg), add 10ml of methanol, shake to dissolve trimetazidine hydrochloride, filter, the filtrate was taken as a test solution; An appropriate amount of trimetazidine hydrochloride control was taken, and methanol was added to dissolve and prepare a solution containing 10 mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10ul of each of the above two solutions, respectively point on the same silica gel GF254 thin layer plate, with ethanol-concentrated ammonia (8:2) as the developing solvent, expand, take out, dry, set the UV lamp (254nm) under the view. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
- 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.
- two items (3) and (4) above can be selected as one item.
examination
- Related substances take an appropriate amount of the fine powder of this product (about 0.2g of trimetazidine hydrochloride), put it in a 50ml measuring flask, add an appropriate amount of water and ultrasound to dissolve trimetazidine hydrochloride, and dilute it to the scale with water, shake well, centrifuge (5000 rpm) for 15 minutes, take the supernatant as the test solution; Take 1ml of the test solution with precision, put it in a 100ml measuring flask, dilute it with water to the scale, 2ml of the control solution was accurately measured, placed in a 100ml measuring flask, diluted with water to the scale, and shaken to obtain a sensitivity solution. According to the method of trimetazidine hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, the chromatographic peaks before the relative retention time of 0.13 shall be subtracted, and 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%). The chromatographic peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored (0.02%). 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).
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), 0.05mol/L hydrochloric acid solution was used as the dissolution medium, and the rotation speed was 50 rpm, operate according to the law, after 30 minutes, take 10ml of the solution, filter, take the filtrate as the test solution; Take the appropriate amount of trimetazidine hydrochloride control, precision weighing, the dissolution medium was added and dissolved and diluted to prepare a solution containing 20ug per 1 ml, which was shaken well as a control solution. The absorbance of the above two Solutions was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution amount of each tablet was calculated. The limit shall be 70% of the labeled amount and shall be in accordance with the provisions of the other requirements under the tablet item (General rule 0101).
Content determination
Take 10 tablets of this product, put them in 100ml measuring flask respectively, add appropriate amount of water, sonicate to dissolve trimetazidine hydrochloride, dilute with water to the scale, shake, centrifuge (at 5000 rpm) for 15 minutes, take the supernatant as the test solution; Take the trimetazidine hydrochloride control by precision weighing, water was added for dissolution and quantitative dilution to prepare a solution containing 0.2 mg per 1 ml as a control solution. The content of each tablet was calculated according to the method under the item of trimetazidine hydrochloride content determination, and the average content of 10 tablets was obtained.
category
with trimetazidine hydrochloride.
specification
20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:23:01
Takkmint - Trimetazidine hydrochloride capsules
Authoritative Data Verified Data
This product contains tramadol hydrochloride (C14H22N203 • 2HC1) should be 90.0% ~ 110.0% of label amount.
trait
The contents of this product are white or off-white powder or granules and powder.
identification
- take an appropriate amount of the contents of this product (about 10mg of trimetazidine hydrochloride), add 5ml of water, shake to dissolve trimetazidine hydrochloride, filter, and take 1 ml of filtrate, according to the test of item (1) under the identification of trimetazidine hydrochloride, the same reaction was shown.
- take an appropriate amount of fine powder in the contents of this product and add 0.1 mol / L hydrochloric acid solution is made into a solution containing 20ug of trimetazidine hydrochloride per 1 ml, filtered and measured by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 231nm.
- 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.
examination
- relevant substances: take an appropriate amount of fine powder in the content of this product (equivalent to 0.2g of trimetazidine hydrochloride), put it in a 50ml measuring flask, add appropriate amount of water, and sonicate to dissolve trimetazidine hydrochloride, dilute to the scale with water, shake, centrifuge (5000 rpm) for 15 minutes, take the supernatant as the test solution; Take 1 ml of the test solution with precision and put it in a 100ml measuring flask, dilute with water to the scale, shake, as a control solution; Precision take the control solution 2ml, 100ml flask, diluted with water to the scale, shake, as a sensitivity solution. According to the method of trimetazidine hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, the chromatographic peaks before the relative retention time of 0.13 shall be subtracted, and 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%). The chromatographic peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored (0.02%). 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).
- dissolution: according to the dissolution and release determination method (General rule 0931 method 1), ML of mol/L hydrochloric acid solution was used as the dissolution medium, and the rotation speed was 50 rpm, operate according to law, after 30 minutes, take 10ml of the solution, filter, take the filtrate as the test solution; Take the appropriate amount of tramadol hydrochloride control, precision weighing, A solution containing 0.05 per 1 ml was prepared by dissolving and quantitatively diluting with a 20% mol/L hydrochloric acid solution, and shaken to obtain a control solution. According to the chromatographic conditions under the content determination item, each L01 of the test solution and the reference solution is accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded. According to the external standard method, the dissolution amount of each particle was calculated by the peak area. 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
Take 10 capsules of this product, pour the contents into 100ml measuring flask respectively, wash the capsule shell with appropriate amount of water, merge the lotion into the measuring flask, add appropriate amount of water and ultrasound to dissolve trimetazidine hydrochloride, dilute to the scale with water, shake, centrifuge (5000 rpm) for 15 minutes, take the supernatant as the test solution; Take the trimetazidine hydrochloride control by precision weighing, water was added for dissolution and quantitative dilution to prepare a solution containing 0.2mg per 1 ml as a control solution. The content of each granule was calculated according to the method under the item of trimetazidine hydrochloride content determination, and the average content of 10 granules was obtained.
category
with trimetazidine hydrochloride.
specification
20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:23:02
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View History
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