1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride
1-(2,6-dimethylphenoxy)-2-propanamine hydrochloride
CAS: 5370-01-4
Molecular Formula: C11H18ClNO
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Names and Identifiers
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Physico-chemical Properties
| Molecular Formula | C11H18ClNO |
| Molar Mass | 215.72 |
| Density | 1.12 g/cm3 |
| Melting Point | 200-203°C |
| Boling Point | 271.5ºC at 760 mmHg |
| Solubility | Soluble in water or ethanol, almost insoluble in ether |
| Appearance | White to off-white solid |
| Color | white |
| Maximum wavelength(λmax) | ['272nm(MeOH)(lit.)'] |
| Merck | 14,6169 |
| pKa | 9.0(at 25℃) |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic |
| MDL | MFCD00216024 |
| Use | Antiarrhythmic drugs |
| In vitro study | Mexiletine is a local anesthetic, antiarrhythmic drug (Class Ib), similar in structure to lidocaine, but effective orally. Mexiletine inhibits the sodium ion influx required for pulse initiation and conduction, thereby reducing the rate of action potential rise. It achieves a reduction in the flow of sodium ions by inhibiting the sodium channel. Mexiletine reduces the effective refractory period (ERP) of cardiac Purkinje fibers. The decrease in ERP is less than the decrease in action potential duration (APD), which results in an increase in the ERP/APD ratio. It did not significantly affect resting membrane potential or sinus node automaticity, left ventricular function, systolic arterial pressure, atrioventricular (AV) conduction velocity, QRS or QT interval. |
| In vivo study | Mexiletines are able to work quickly and have counteracting Kinetics, which means that they have no or little effect when the heart rate is slow, and have a greater effect when the heart rate is fast. It shortens the action potential duration, reduces the refractoriness, and lowers the Vmax of partially depolarized cells with fast response action potentials. Mexiletine does not change nor reduce the duration of action potentials. Mexiletine is well absorbed from the gastrointestinal tract (90% bioavailability). |
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R36/37/38 - Irritating to eyes, respiratory system and skin. R22 - Harmful if swallowed |
| Safety Description | S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| WGK Germany | 3 |
| RTECS | KR9300000 |
| HS Code | 2922190900 |
| Toxicity | LD50 in male, female rats, mice, rabbits (mg/kg): 350, 400, 310, 400, 180, 160 orally; in male, female rats, mice (mg/kg): 27, 30, 43, 50 i.v. (Kast) |
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Standard
Authoritative Data Verified Data
This product is (±)-l-(2, 6-dimethylphenoxy)-2-propylamine hydrochloride. The content of C11H17NO • HCl shall not be less than 98.5% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Almost odorless.
- This product is soluble in water or ethanol, and almost insoluble in ether.
melting point
The melting point of this product (General 0612) is 200~204°C
Last Update：2022-01-01 15:32:30
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 0.1g of this product, add 2ml of water to dissolve, and add 2 drops of Iodine test solution to generate brown-red precipitate.
- take this product, add 0.01mol/L hydrochloric acid solution to dissolve and dilute to make a solution containing about 0401 mg per 1 ml, and measure according to ultraviolet-visible spectrophotometry (general rule), there is a maximum absorption at a wavelength of 261nm, and the absorbance is 0.44 to 0.48.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 381).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:32:31
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Exam
Authoritative Data Verified Data
acidity
take l.Og of this product, Add 10ml of water to dissolve, and measure it according to law (General rule 0631). The pH value should be 4.0~5.5.
clarity and color of solution
take 0.5g of this product, add 0901 of water to dissolve, the solution should be clear and colorless; If the color is colored, check according to law (General rule first law), and compare with the orange-yellow No. 3 Standard Colorimetric solution, not deeper.
Related substances
take about 50mg of this product, accurately weigh it, put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as a test solution; Take another 2,6-dimethyl phenol (impurity I) standard sample, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 2mg per 1ml, precision measuring 1ml, put in 200ml measuring flask, then, 1ml of human test solution was added precisely, diluted to the scale with the mobile phase, and then shaken to serve as a control solution. According to the high performance liquid chromatography (General 0512) test, using eighteen alkyl silane bonded silica gel as filler; Methanol-O. 1 mol/L sodium acetate (50:50)(with glacial acetic acid to adjust the pH value to 5.8 0.1) as mobile phase; The detection wavelength was 262nm. The number of theoretical plates shall not be less than 1000 calculated by mexiletine peak, the separation degree between mexiletine peak and impurity I peak shall be greater than 6.0, and the separation degree between mexiletine peak and adjacent impurity peak shall meet the requirements. 20 u1 of the test solution and the control solution were respectively injected into the human 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 peak, the peak area shall be calculated according to the external standard method, and shall not exceed 0.2%; the Peak area of other single impurity shall not be greater than 0.4 times (0.2%) of the peak area of Sino-US Schiff in the control solution, and the sum of the peak areas of other impurities shall not be greater than the peak area of Sino-US Schiff in the control solution except for impurity I Peak (0.5%).
loss on drying
take this product, dry to constant weight at 105 ℃, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
take 2.0g of this product and check it according to law (General rule 0841). The remaining residue 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).
Last Update：2022-01-01 15:32:32
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Content determination
Authoritative Data Verified Data
take this product about 0.16g, precision weighing, add glacial acetic acid 25ml and acetic anhydride 25ml, shake to dissolve, according to the potential titration method (General rule 0701), immediately with perchloric acid titration solution (O. 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 21.57mg of C11H17NO. HCl.
Last Update：2022-01-01 15:32:32
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Category
Authoritative Data Verified Data
antiarrhythmic drugs.
Last Update：2022-01-01 15:32:32
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:32:33
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Mexiletine Hydrochloride Tablets
Authoritative Data Verified Data
This product contains mexiletine hydrochloride (C11H17NO • HCl) should be 93.0% ~ 107.0% of the label amount.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (about 0.5g of mexiletine hydrochloride), add 10ml of water, stir, dissolve mexiletine hydrochloride, filter, the filtrate showed the same reaction according to the tests of identification (1) and (4) under mexiletine hydrochloride.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of Nm.
examination
- Related substances take an appropriate amount of fine powder of this product (about 50mg of mexiletine hydrochloride), put it in a 10ml measuring flask, add mobile phase to dissolve mexiletine hydrochloride, dilute it to the scale, and shake it well, filter, take the filtrate as a test solution; Take 1ml of precision, 100ml flask, diluted with mobile phase to the scale, shake, as a control solution. According to the chromatographic conditions under the content determination item, except that the detection wavelength was 262NM. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, 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%).
- 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 with eighteen alkyl silane bonded silica gel as filler; With methanol-O. The mobile phase consisted of 1 mol/L sodium acetate solution (50:50) (pH adjusted to 5.8±0.1 with glacial acetic acid). The detection wavelength was at 216nm. The number of theoretical plates shall not be less than 1000 calculated by mexiletine peak, and the degree of separation between mexiletine peak and adjacent impurity peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine, precision weighing an appropriate amount (about 50mg equivalent to mexiletine hydrochloride), put it in a 100ml measuring flask, add water 70ml, sonicate mexiletine hydrochloride for about 10 minutes, let it cool, dilute to scale with water, shake well, filter with micropore filter membrane (0.45um), and take 5ml of continued filtrate with precise volume, put it in a 100ml measuring flask, dilute it to scale with water, shake well, use it as a test solution, and record the chromatogram with 20u1 injection, precision weighing, dissolved in water and quantitative dilution of solution containing 25ug per lml, the same method. According to the external standard method to calculate the peak area, that is.
category storage
Same as mexiletine hydrochloride.
specification
(l)50mg (2)100mg
Last Update：2022-01-01 15:32:33
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Mexiletine hydrochloride injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution of mexiletine hydrochloride. Containing mexiletine hydrochloride (C11H17NO • HC1) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take 1ml of this product and add 2 drops of Iodine test solution to produce brown-red precipitate.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of 261mn.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 4.5 to 0631 (general).
- precise amount of related substances: Take appropriate amount of this product and quantitatively dilute it with mobile phase to prepare a solution containing about 5mg of mexiletine hydrochloride per 1ml as the test solution, precision weighing, dissolving and quantitatively diluting with mobile phase to make a solution containing about 2mg per 1ml. Take 1ml for precision measurement, put it in a 200ml measuring flask, and then add 1ml of human test solution, dilute to the scale with the mobile phase, shake, and serve as a control solution. 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 according to the method for determining the related substances of mexiletine hydrochloride, 0.2% of the labeled amount of mexiletine hydrochloride shall not be passed, and the peak area of other individual impurities shall not be greater than that of mexiletine hydrochloride in the control solution (0.5%); Except for impurity I peak, the sum of the peak areas of other impurities shall not be greater than 2 times (1.0%) The Peak area of mexiletine hydrochloride in the control solution. Bacterial endotoxin take this product, check according to law (General 1143), each 1 mg mexiletine hydrochloride containing endotoxin amount should be less than 0.50EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision measure 2ml of this product, put it in a 200ml measuring flask, and add O. The Olmol/L hydrochloric acid solution was diluted to the scale, and was shaken well. As the test solution, the absorbance was measured at the wavelength of 261nm by ultraviolet-visible spectrophotometry (General rule 0401); another mexiletine hydrochloride reference, precision weighing, plus O.Olmol/L hydrochloric acid solution is dissolved and quantitatively diluted to make a solution containing about 0.5mg per 1 ml, which is determined and calculated by the same method.
category
Same as mexiletine hydrochloride.
specification
2ml:lOOmg
storage
sealed and kept in a cool dark place.
Last Update：2022-01-01 15:32:34
1-Methyl-2-(2,6-xyloxy)ethylamine hydrochloride - Mexiletine hydrochloride capsules
Authoritative Data Verified Data
This product contains mexiletine hydrochloride (C11H17NO • HCI) should be 90.0% ~ 110.0% of the label amount.
trait
The content of this product is white powder.
identification
- take an appropriate amount of the contents of this product (about 0.5g equivalent to mexiletine hydrochloride), add 10ml of water, shake, filter; Filtrate identification under mexiletine hydrochloride (1), (4) the test showed the same response.
- the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General 0401), and there was a maximum absorption at a wavelength of 261mn.
examination
should comply with the relevant provisions under the capsule (General rule 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 50mg of mexiletine hydrochloride) accurately, and put it in a 100ml measuring flask, add about 50ml of 0.01mol/L hydrochloric acid solution, fully shake to dissolve mexiletine hydrochloride, and use O. Dilute Olmol/L hydrochloric acid solution to the scale, shake well, filter with 0401 um microporous membrane filter, take the filtrate as the test solution, according to ultraviolet-visible spectrophotometry (general rule), determine the absorbance at the wavelength of 261nm; Take the reference substance of mexiletine hydrochloride, precisely weigh, add 0.01mol/L hydrochloric acid solution to dissolve and quantitatively dilute to make a solution containing about 0.5mg per 1 ml, the same method of determination, calculation, that is.
category
Same as mexiletine hydrochloride.
specification
(l)50mg (2)100mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:32:35
Supplier List
Multiple SpecificationsSpot supply
Product Name: Mexiletine hydrochloride Visit Supplier Webpage Request for quotationCAS: 5370-01-4
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Multiple SpecificationsSpot supply
Product Name: Mexiletine hydrochloride Visit Supplier Webpage Request for quotationCAS: 5370-01-4
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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