PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride
CAS: 318-98-9
Molecular Formula: C16H22ClNO2
PROPRANOLOL HYDROCHLORIDE - Names and Identifiers
| Name | Propranolol Hydrochloride |
| Synonyms | Propranolol HCl PROPRANOLOL HCL PROPANOLOL HYDROCHLORIDE Propranolol Hydrochloride PROPRANOLOL HYDROCHLORIDE DL-PROPRANOLOL HYDROCHLORIDE Propranolol Hydrochloride (200 mg) dl-1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride (RS)-1-[(1-METHYLETHYL)AMINO]-3-(1-NAPHTHALENYLOXY)-2-PROPANOL HYDROCHLORIDE |
| CAS | 318-98-9 |
| EINECS | 206-268-7 |
| InChI | InChI=1/C16H21NO2.ClH/c1-12(2)17-10-14(18)11-19-16-9-5-7-13-6-3-4-8-15(13)16;/h3-9,12,14,17-18H,10-11H2,1-2H3;1H |
| InChIKey | ZMRUPTIKESYGQW-UHFFFAOYSA-N |
PROPRANOLOL HYDROCHLORIDE - Physico-chemical Properties
| Molecular Formula | C16H22ClNO2 |
| Molar Mass | 295.8 |
| Melting Point | 163-165°C(lit.) |
| Boling Point | 434.9°C at 760 mmHg |
| Flash Point | 9℃ |
| Water Solubility | SOLUBLE |
| Solubility | H2O: 50mg/mL, clear, colorless |
| Vapor Presure | 2.48E-08mmHg at 25°C |
| Appearance | powder |
| Color | white |
| Merck | 14,7840 |
| BRN | 4164259 |
| Storage Condition | 2-8°C |
| Use | For a variety of functional arrhythmias, supraventricular and ventricular ectopic extrasystoles, atrial fibrillation and anesthesia-induced arrhythmias |
PROPRANOLOL HYDROCHLORIDE - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S22 - Do not breathe dust. 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. S7 - Keep container tightly closed. |
| UN IDs | UN1230 - class 3 - PG 2 - Methanol, solution |
| WGK Germany | 3 |
| RTECS | UB7525000 |
| FLUKA BRAND F CODES | 10 |
| HS Code | 29221990 |
| Hazard Class | IRRITANT |
| Toxicity | LD50 in mice (mg/kg): 565 orally; 22 i.v.; 107 i.p. (Martin, Linee) |
PROPRANOLOL HYDROCHLORIDE - Standard
Authoritative Data Verified Data
This product is 1-isopropylamino-3-(l-naphthyloxy)-2-propanol hydrochloride. The content of C16H21N02 • HCl shall not be less than 99.0% calculated on a dry basis.
Last Update：2024-01-02 23:10:35
PROPRANOLOL HYDROCHLORIDE - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is soluble in water or ethanol, and slightly soluble in chloroform.
melting point
The melting point of this product (General 0612) is 162~165 ℃.
Last Update：2022-01-01 15:35:02
PROPRANOLOL HYDROCHLORIDE - Differential diagnosis
Authoritative Data Verified Data
- take this product, dissolve and dilute with fermentation broth to prepare a solution containing about 20ug per 1 ml, and measure by UV-Vis spectrophotometry (General 0401), there is an absorption maximum at a wavelength of 290nm and 319mn.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 396).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:35:03
PROPRANOLOL HYDROCHLORIDE - 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 5.0~6.5.
clarity and color of solution
take l.Og of this product, add water 20ml to dissolve, the solution should be clear and colorless; If the color is colored, compared with the yellow No. 1 Standard Colorimetric solution (General rule 0901 first method), it should not be deeper.
free naphthol
Take 20mg of this product, add 2ml of ethanol and 2ml of 10% sodium hydroxide solution, shake to dissolve, add 1ml of nitrogen benzene sulfonic acid test solution, shake well, and place for 3 minutes, no deeper (20%) compared to a solution of α-naphthol in ethanol (0.03% α-naphthol per 1ml) of control prepared by the same method.
Related substances
take this product, add the mobile phase to dissolve and dilute to make a solution containing about 1 mg per 1 ml, as a test solution; Take an appropriate amount of precision, A solution containing about 2ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. Tested according to high performance liquid chromatography (General 0512). Silica gel bonded with eighteen alkyl silane as filler; Acetonitrile-water-acid (55:45:0.1) mixture (take sodium dodecyl sulfate 1.6g and dihydrogen tetrabutyl ammonium phosphate 0.31g dissolved in mL of mixture, using 2mol / L sodium hydroxide solution to adjust the pH value to 3.3) as mobile phase; The detection wavelength was 292nm. Take the sample solution 20 u1 and inject it into human liquid chromatograph. The retention time of propranolol peak is about 5 minutes, the number of theoretical plates shall not be less than 3000 based on the propranolol peak, and the tailing factor shall not be more than 2.0. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 7 times of the retention time of the main component chromatographic 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 (0.1%) of the area of the main peak of the control solution; the sum of each impurity peak area shall not be greater than 2 times (0.4%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105 ℃, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 15:35:04
PROPRANOLOL HYDROCHLORIDE - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add acetic anhydride-glacial acetic acid (7:3) 40ml mixture to dissolve, according to the potential titration method (General 0701), with perchloric acid titration solution (O. 1 mol/L) titration, and the titration results were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 29.58mg of C16H21N02-HCl.
Last Update：2022-01-01 15:35:05
PROPRANOLOL HYDROCHLORIDE - Category
Authoritative Data Verified Data
B adrenergic receptor blockers.
Last Update：2022-01-01 15:35:05
PROPRANOLOL HYDROCHLORIDE - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:35:05
PROPRANOLOL HYDROCHLORIDE - Propranolol Hydrochloride Tablets
Authoritative Data Verified Data
This product contains propranolol hydrochloride (C16H21N02 • 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 (equivalent to 0.lg of propranolol hydrochloride), add 20ml of ethanol, stir to dissolve propranolol hydrochloride, filter, evaporate the filtrate, and identify the residue according to the item of propranolol hydrochloride (3) one trial showed the same response.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at wavelengths of NM and Nm.
examination
- Content uniformity take 1 tablet of this product, put it in a 50ml measuring flask, add 1 ml of water, shake to completely disintegrate, Add 30ml of methanol, and follow the method under the content determination item, from the "shaking for 5 minutes", the content shall be determined according to law and shall comply with the regulations (General rule 0941).
- dissolution the dissolution of this product was determined according to the dissolution and release determination method (General rule 0931, Method 1), and the hydrochloric acid solution (1-100) was used as the dissolution medium at RPM, according to the law, after 30 minutes, an appropriate amount of the solution was taken, filtered, and the filtrate was taken and subjected to ultraviolet-visible spectrophotometry (General rule 0401), and the absorbance was measured at a wavelength of MN. In addition, the Propranolol hydrochloride reference substance was accurately weighed, dissolved and quantitatively diluted with dissolution medium to make a solution containing 10ug per lml, and the dissolution amount of each tablet was calculated by the same method. 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
Take 20 tablets of this product, precise weighing, fine grinding, precise weighing appropriate amount (about equivalent to 20mg of propranolol hydrochloride), put it in a 100ml measuring flask, add 2ml of water, shake for 5 minutes to dissolve propranolol hydrochloride, dilute to scale with methanol, shake, filter, Take 5ml of filtrate accurately, put it in 50ml measuring flask, dilute to scale with methanol, shake well, the absorbance was measured at a wavelength of 0401 mn according to UV-Vis spectrophotometry (General Rule 207), and the absorption coefficient of C16H21N02-HCl was calculated.
category
Same as propranolol hydrochloride.
specification
lOmg
storage
sealed storage.
Last Update：2022-01-01 15:35:06
PROPRANOLOL HYDROCHLORIDE - Propranolol hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of propranolol hydrochloride. Propranolol hydrochloride (C16H21N02 • 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 an appropriate amount of this product and add a few drops of silicotungstic acid test solution, which will produce light pink precipitate.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of Nm.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 3.0 to 4.0 (General 0631).
- Related substances this product was taken as a test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with a mobile phase to prepare a solution containing about 2ug of propranolol hydrochloride per 1 ml as a control solution. If there are impurity peaks in the chromatogram of the test solution, the single impurity peak area shall not be greater than the main peak area of the control solution (0.2%); the sum of each impurity peak area shall not be greater than 4 times (0.8%) of the main peak area of the control solution.
- bacterial endotoxin this product, according to the law to check (General 1143), each 1 mg Propranolol hydrochloride containing endotoxin should be less than 50EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
accurately measure the product, and quantitatively dilute it with methanol to make a solution containing about 20ug of propranolol hydrochloride in each lml, shake well, and then perform ultraviolet-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 290nm, and the absorbance was calculated as an absorption coefficient of C16H21N0 · HCI of 207.
category
Same as propranolol hydrochloride.
specification
5ml:5mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:35:07
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CAS: 318-98-9
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CAS: 318-98-9
Tel: 0086-551-65418684
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Mobile: 0086 189 4982 3763
QQ: 2881500840
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