盐酸普罗帕酮标准品
Propafenone HCl
CAS: 34183-22-7
Molecular Formula: C21H28ClNO3
盐酸普罗帕酮标准品 - Names and Identifiers
| Name | Propafenone HCl |
| Synonyms | sa79 SA 79 wz884 WZ 884 Pronon Rythmol Arythmol Rytmonorm Fenoprain rytmonorm Rythmol SR Baxarytmon Rhythmonorm Propafenone HCl UNII-33XCH0HOCD PROPAFENONE HCL Propafenon hydrochlorid Propafenone hydrochloride Propafenon hydrochlorid [German] 2'-(2-Hydroxy-3-(propylamino)propoxy)-3-phenylpropiophenone hydrochloride Propiophenone, 2'-(2-hydroxy-3-(propylamino)propoxy)-3-phenyl-, hydrochloride 1-[2-[2-hydroxy-3-(propylamino)propoxy]phenyl]-3-phenylpropan-1-one hydrochloride 1-(2-(2-Hydroxy-3-(propylamino)propoxy)phenyl)-3-phenylpropan-1-one hydrochloride 1-[2-(2-HYDROXY-3-[PROPYLAMINO]-PROPOXY)PHENYL]-3-PHENYL-1-PROPANONE HYDROCHLORIDE 1-Propanone, 1-(2-(2-hydroxy-3-(propylamino)propoxy)phenyl)-3-phenyl-, hydrochloride |
| CAS | 34183-22-7 |
| EINECS | 251-867-9 |
| InChI | InChI=1/C21H27NO3.ClH/c1-2-14-22-15-18(23)16-25-21-11-7-6-10-19(21)20(24)13-12-17-8-4-3-5-9-17;/h3-11,18,22-23H,2,12-16H2,1H3;1H |
盐酸普罗帕酮标准品 - Physico-chemical Properties
| Molecular Formula | C21H28ClNO3 |
| Molar Mass | 377.9 |
| Melting Point | 165-1670C |
| Boling Point | 519.6°C at 760 mmHg |
| Flash Point | 268°C |
| Solubility | Soluble in methanol (50 mg/ml), water(slightly soluble in cold water), ethanol, acetone |
| Vapor Presure | 1.27E-11mmHg at 25°C |
| Appearance | neat |
| Color | White to Off-White |
| Maximum wavelength(λmax) | ['303nm(MeOH)(lit.)'] |
| Merck | 14,7794 |
| Storage Condition | 2-8°C |
| Physical and Chemical Properties | Character: white crystalline powder, odorless, bitter. This product is slightly soluble in ethanol, chloroform or glacial acetic acid, and slightly soluble in water. |
| Use | For the prevention and treatment of ventricular or supraventricular ectopic tachycardia, tachycardia, pre-excitation syndrome and the prevention of ventricular fibrillation after shock cardioversion |
盐酸普罗帕酮标准品 - Risk and Safety
| Risk Codes | R46 - May cause heritable genetic damage R22 - Harmful if swallowed |
| Safety Description | S53 - Avoid exposure - obtain special instructions before use. 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.) |
| WGK Germany | 3 |
| RTECS | UH2833000 |
| HS Code | 2922504500 |
| Toxicity | LD50 in rats (mg/kg): 18.8 i.v.; 700 orally (Hapke, Prigge) |
盐酸普罗帕酮标准品 - Standard
Authoritative Data Verified Data
This product is 3-phenyl-l-[2-[3-(propy1)-2-cyclopropoxy] phenyl]-1-acetone hydrochloride. The content of C21H27N03 • HC1 shall not be less than 99.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
盐酸普罗帕酮标准品 - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is slightly soluble in ethanol, chloroform or glacial acetic acid, and slightly soluble in water.
melting point
The melting point of this product (General 0612) is 171~174°C.
Last Update：2022-01-01 15:34:57
盐酸普罗帕酮标准品 - Differential diagnosis
Authoritative Data Verified Data
- take about 20mg of this product and add 4ml ethanol to dissolve it. Add the human dinitrophenylhydrazine test solution and shake to generate golden yellow precipitate.
- take this product, dissolve and dilute with ethanol to make a solution containing about 20ug per lml, and measure by UV-Vis spectrophotometry (General rule 0401), at 210nm, there is a maximum absorption at the wavelength of 248nm and 304nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 395).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:34:58
盐酸普罗帕酮标准品 - Exam
Authoritative Data Verified Data
clarity of the fermentation solution
take 0.10g of this product, add 20ml of methanol, heat and dissolve in a water bath at about 60°C, let it cool, and the solution should be clear; If it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), should not be more concentrated.
Related substances
take this product, add an appropriate amount of acetonitrile to dissolve, dilute with mobile phase to prepare a solution containing about 1mg of Propafenone Hydrochloride in each lml as a test solution; Take an appropriate amount for precision measurement, A solution containing about 1mg per 1 ml was prepared as a control solution by quantitative dilution with the mobile phase. According to the high performance liquid chromatography (General 0512) test, using octanosilane bonded silica gel as filler, 0.0015mol/L dipotassium hydrogen phosphate (adjusted to pH 2.5 with phosphoric acid)-acetonitrile (65:35) as mobile phase; The detection wavelength was 220nm. The number of theoretical plates shall not be less than 2000 based on the Propafenone peak. 10 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 the area of the main peak of the control solution (0.1% ) , the sum of each impurity peak area shall not be greater than 3 times (0.3%) of the main peak area of the control solution.
residual solvent
take about 0.2g of this product, precision weighing, top empty bottle, Precision Add dimethyl sulfoxide 5ml to dissolve, seal, as a test solution; Another methanol, ethanol, an appropriate amount of acetone and ethyl acetate, precision weighing, quantitative dilution with dimethyl sulfoxide to make a solution containing about 0.12mg of methanol and 0.2mg of ethanol, propanol and ethyl acetate in each lml, precision measuring 5ml, top empty bottle, sealed, as a control solution. Test as residual solvent assay (General 0861 second method). (5%) phenyl-( 95%) methyl polysiloxane (or polar similar) as the fixing liquid; The initial temperature is 40°C, maintained for 7 minutes, at a rate of 8°C per minute to 120°C, it was maintained for 15 minutes; The inlet temperature was 200°C; The detector temperature was 250X:; The headspace bottle equilibration temperature was 90°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the external standard method to calculate the peak area, methanol, ethanol, acetone and ethyl acetate 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 0.5% (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 ignition residue shall not be more than 10 parts per million (ppm) and shall be inspected according to law (General rule 0821 second law).
Last Update：2022-01-01 15:34:58
盐酸普罗帕酮标准品 - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add anhydrous formic acid 2ml to dissolve, add acetic anhydride 50ml, according to the potential titration method (General rule 0701), immediately 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 37.79mg of C21H27N03. Hc1.
Last Update：2022-01-01 15:34:59
盐酸普罗帕酮标准品 - Category
Authoritative Data Verified Data
antiarrhythmic drugs.
Last Update：2022-01-01 15:34:59
盐酸普罗帕酮标准品 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:34:59
盐酸普罗帕酮标准品 - Propafenone Hydrochloride Tablets
Authoritative Data Verified Data
This product contains Propafenone Hydrochloride (C21H27N03 • HCI) should be 93.0% to 107.0% of the label.
trait
This product is white or off-white.
identification
- take an appropriate amount of fine powder of this product (about 20mg equivalent to Propafenone Hydrochloride), add 4ml of ethanol to dissolve Propafenone Hydrochloride, let stand for a moment, take the supernatant, add dinitrophenylhydrazine test solution, shake, that is, a golden yellow precipitate was formed.
- take the fine powder of this product, dissolve it with ethanol and dilute it to make a solution containing 20ug of Propafenone Hydrochloride per 1 ml, filter it, and measure the filtrate by UV-Vis spectrophotometry (General rule 0401), there is maximum absorption at wavelengths of 210Nm, 248nm and 304nm.
- take the fine powder of this product, add water to dissolve Propafenone Hydrochloride, filter, the filtrate shows chloride to identify (1) reaction (General rule 0301).
examination
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with water 1000ml as the dissolution medium, the speed is 75 rpm, according to the law, after 45 minutes, take the solution, filter, accurately take the appropriate amount of filtrate, and quantitatively dilute with water to make a solution containing about 25ug of Propafenone Hydrochloride per 1 ml, according to UV-visible spectrophotometry (General rule 0401), determine absorbance at 250nm wavelength; Take appropriate amount of Propafenone Hydrochloride reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 25ug per 1 ml, which was determined by the same method, and the dissolution amount of each tablet was calculated. The limit is 70% 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, precise weighing, fine grinding, precise weighing appropriate amount (about 50mg equivalent to Propafenone Hydrochloride), put it in a 100ml measuring flask, add appropriate amount of ethanol, shake to dissolve Propafenone Hydrochloride, add ethanol to dilute to the scale, shake, filter, take a precise amount of filtrate to continue 5ml, 100ml flask, add ethanol to dilute to the scale, shake. The absorbance was measured at a wavelength of 0401 NM according to UV-Vis spectrophotometry (General Rule 220), and the absorption coefficient of C21H27N03 · HCl was calculated.
category
Same as Propafenone Hydrochloride.
specification
(l ) 50mg (2) lOOmg (3)150mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:35:00
盐酸普罗帕酮标准品 - Propafenone Hydrochloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of Propafenone Hydrochloride. Propafenone Hydrochloride (C21H27N03 • HCl) shall be present in an amount of 90.0% to 110.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- take 5ml of this product, put it on a water bath to dry, add 4ml of ethanol to dissolve the residue, add dinitrophenylhydrazine test solution, shake, and generate golden yellow precipitate.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at wavelengths of NM, NM and Nm.
examination
- the pH value should be 3.5 to 5.0 (General 0631).
- Related substances take this product and dilute it with mobile phase to prepare a solution containing about 1 mg of Propafenone Hydrochloride per 1 ml as a test solution; Take appropriate amount with precision, A solution containing approximately 1 ml per 1 ml was prepared as a control solution by quantitative dilution with the mobile phase. According to the method of Propafenone Hydrochloride related substances. 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.
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg Propafenone Hydrochloride containing endotoxin amount should be less than 1.5EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product, and quantitatively dilute it with ethanol to a solution containing about 20ug of Propafenone Hydrochloride per lml, according to ultraviolet-visible spectrophotometry (General rule 0401 ), the absorbance was measured at a wavelength of 248nm and calculated as the absorption coefficient of C21H27N03. HCl was 220.
category
Same as Propafenone Hydrochloride.
specification
(l)5ml:17.5mg (2)5ml:35mg (3)10ml:35mg (4)20ml:70mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:35:01
盐酸普罗帕酮标准品 - Propafenone Hydrochloride capsules
Authoritative Data Verified Data
This product contains Propafenone Hydrochloride (C21H27N03 • HCl) should be 90.0% ~ 110.0% of the label amount.
identification
- take an appropriate amount of the content of this product (about 20mg equivalent to Propafenone Hydrochloride), add 4ml of ethanol, dissolve Propafenone Hydrochloride, filter, take the filtrate and add dinitrophenylhydrazine test solution, shake, and generate golden yellow precipitate.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at wavelengths of 210mn, 248nm and 304nm.
- take the contents of this product, add water to dissolve Propafenone Hydrochloride, filter, filtrate chloride identification reaction (General 0301).
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, accurately weigh an appropriate amount (about 20mg equivalent to Propafenone Hydrochloride), put it in a 100ml children's bottle, and add an appropriate amount of ethanol, shake to dissolve Propafenone Hydrochloride (if necessary, heat it in a warm water bath and let it dissolve and then let it cool), dilute to the scale with ethanol, shake well, filter, and take 5ml of continued filtrate with precision, put 50ml measuring flask, add ethanol to dilute to the scale, shake. The absorbance was measured at a wavelength of 0401 NM according to UV-Vis spectrophotometry (General Rule 220), and the absorption coefficient of C21H27N03 · HCl was calculated.
category
Same as Propafenone Hydrochloride.
specification
(l)100mg (2)150mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:35:02
盐酸普罗帕酮标准品 - Reference Information
| pharmacological effects | 1. propafenone hydrochloride is an Ic sodium channel blocker and is a broad-spectrum antiarrhythmic drug. The experimental results in isolated animal myocardium show that 0.5~1 μg/min can reduce the depolarization of systolic phase, thus prolonging conduction, slightly prolonging the duration of action potential and effective refractory period, and can increase the threshold potential of myocardial cells, significantly reducing the spontaneous excitability of myocardium. It not only acts on the atrium and ventricle (mainly affects Pujinye fibers, but has little effect on the myocardium), but also acts on the formation and conduction of excitement. Clinical data show that the therapeutic dose (300mg orally and 30mg intravenously) can reduce myocardial stress, the effect is lasting, PQ and QRS are increased, and the effective refractory period of atrium and atrioventricular node is prolonged. It has an antagonistic effect on various types of experimental arrhythmia. The antiarrhythmic effect is related to its membrane stabilizing effect and competitive beta blocking effect. It still has a weak calcium antagonism (100 times weaker than verapamil), and has a mild myocardial inhibition effect, increasing end-stage diastolic blood pressure, and reducing stroke volume. Its effects are all proportional to the dose of the drug. It also has a mild effect of lowering blood pressure and slowing heart rate. 2. In vitro experiments show that propafenone can relax coronary artery and bronchial smooth muscle. 3. It has a local anesthetic effect similar to that of procaine. 4. Renal dysfunction occurred after 6 months of oral administration of 180~360(mg/kg)/day (12~24 times of the maximum recommended dose for adults) in rats, with inflammatory and non-inflammatory reactions in renal tubules and interstitium. Liver steatosis can be found when long-term rats are given 19 times the maximum recommended dosage for adults. |
| indication | is used for the prevention of paroxysmal ventricular tachycardia, paroxysmal supraventricular tachycardia and preexcitation syndrome with supraventricular tachycardia, atrial flutter or atrial fibrillation. It can also be used for the treatment of various premature beats. |
| pharmacokinetics | 1. the binding rate of this product to plasma protein is as high as 93%, and the bioavailability will be improved when the dose is increased. 2. The decline of liver function will also increase the bioavailability of drugs, and the clearance of propafenone will slow down when severe liver function is damaged. 3. The pharmacokinetic curve of propafenone is nonlinear. The half-life of the drug is 3.5~4 hours. This product is excreted by the kidneys, mainly metabolites, and a small part (<1%) is the original substance. 4. It cannot be drained through dialysis. |
| original research and reference preparations | 1. original research: first developed by Knoll Pharma and listed in Italy in 1983, with Rytmonorm trade names, tablets, specifications of 150mg and 300mg. It was subsequently listed in Germany, Japan (100mg and 150mg) and the United States. In 2001, Abbott Pharmaceuticals acquired Knoll Pharma and obtained the Rytmonorm holding rights. 2. FDA:RYTHMOL, GLAXO SMITH KLINE LLC,300 mg3, UK: PROPAFENONE NRIM 150MG TABLETS,150, 300mg, NRIM LIMITED MARLBOROUGH HOUSE4, Japan: Pronon Tab. 100mg, 150mg, TOA EIYO LTD. 5. domestic import situation (1) import: trade name yuefulong, specification 150mg, Abbott production (2) import localization: no |
| drug interaction | combined with quinidine can slow down the metabolic process. The combination with local anesthetics can increase the occurrence of side effects of the central nervous system. Propafenone can increase serum digoxin concentration and is dose-dependent. The combination with propranolol and metoprolol can significantly increase its plasma concentration and clearance half-life, but has no effect on propafenone. When combined with warfarin, it can increase warfarin blood concentration and prothrombin time. The combination with cimetidine increased the blood steady-state level of propafenone, but had no effect on its electrophysiological parameters. |
| biological activity | Propafenone HCl is a typical antiarrhythmic drug used to treat diseases related to rapid heartbeat, such as atrial and ventricular arrhythmia. |
| Target | Value |
| use | used to prevent and treat ventricular or supraventricular ectopic hyperactivity, tachycardia, preexcitation syndrome and prevention of ventricular fibrillation after electric shock cardioversion etc. used to prevent and treat ventricular or supraventricular ectopic hyperactivity, tachycardia, preexcitation syndrome and prevention of ventricular fibrillation after electric shock cardioversion etc. |
Last Update：2024-04-09 15:16:50
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