Chlorhydrate de papaverine [French] - Names and Identifiers
Name | Papaverine Hydrochloride
|
Synonyms | Lapav Dipav Vasal PAP H Myobid Alapav Dynovas Copavin Pameion Pavased Delapav Papacon Pavakey Pavabid Pavacen Dilaves Paveron Optenyl Pavnell Pavacap Durapav Cerebid Drapavel Pavatest Ro-Papav Vasospan Dispamil Cerespan Vaso-Pav Therapav Forpavin Papalease NSC 35443 Cepaverin Pavagrant HSDB 3147 Paverolan Artegodan CCRIS 3804 NCI-C56359 Spasmo-nit Cardiospan Papaversan Cardoverina Pap-Kaps-150 Papanerin-HCl Papaverine HCl UNII-23473EC6BQ Papaverinium chloride Papanerin-HCl [German] papaverin hydrochloride Papavarine chlorhydrate Papaverine chlorohydrate Papaverine Hydrochloride Chlorhydrate de papaverine Papaverine monohydrochloride Papaverine Hydrochloride (200 mg) Chlorhydrate de papaverine [French] 1-(3,4-dimethoxybenzyl)-6,7-dimethoxyisoquinoline 6,7-Dimethoxy-1-veratrylisoquinoline hydrochloride Isoquinoline, 6,7-dimethoxy-1-veratryl-, hydrochloride 6,7,3',4'-Tetramethoxy-1-benzylisoquinoline hydrochloride Isoquinoline, 6,7-dimethoxy-1-veratryl-, hydrochloride (8CI) 1-(3,4-Dimethoxybenzyl)-6,7-dimethoxyisoquinoline hydrochloride 1-(3,4-DIMETHOXYBENZYL)-6,7-DIMETHOXYISOQUINOLINE HYDROCHLORIDE Isoquinoline, 1-((3,4-dimethoxyphenyl)methyl)-6,7-dimethoxy-, hydrochloride
|
CAS | 61-25-6
|
EINECS | 200-502-1 |
InChI | InChI=1/C20H21NO4.ClH/c1-22-17-6-5-13(10-18(17)23-2)9-16-15-12-20(25-4)19(24-3)11-14(15)7-8-21-16;/h5-8,10-12H,9H2,1-4H3;1H |
Chlorhydrate de papaverine [French] - Physico-chemical Properties
Molecular Formula | C20H22ClNO4
|
Molar Mass | 375.85 |
Melting Point | 226°C (dec.) |
Boling Point | 483.2°C at 760 mmHg |
Flash Point | 172.2°C |
Water Solubility | freely soluble |
Solubility | H2O: 25mg/mL |
Vapor Presure | 5.01E-09mmHg at 25°C |
Appearance | powder |
Color | white |
Merck | 14,7019 |
BRN | 3921435 |
PH | pH (20g/l, 25℃) : 3.0~4.0 |
Storage Condition | Amber Vial, Refrigerator |
Stability | Stable, but may be light sensitive. |
Sensitive | Light Sensitive |
Use | Used as vasodilator |
Chlorhydrate de papaverine [French] - Risk and Safety
Risk Codes | R22 - Harmful if swallowed
R34 - Causes burns
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.)
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S16 - Keep away from sources of ignition.
|
UN IDs | UN 1544 6.1/PG 3 |
WGK Germany | 1 |
RTECS | NW8575000 |
FLUKA BRAND F CODES | 8 |
TSCA | Yes |
HS Code | 29391900 |
Hazard Class | 6.1 |
Packing Group | III |
Toxicity | LD50 in mice, rats (mg/kg): 27.5, 20 i.v.; 150, 370 s.c. (Levis) |
Chlorhydrate de papaverine [French] - Standard
Authoritative Data Verified Data
This product is l-[(3, 4-dimethoxyphenyl) methyl]-6, 7-dimethoxyisoquinoline hydrochloride. The content of C20H21N04 • HCl shall not be less than 99.0% calculated on a dry basis.
Last Update:2024-01-02 23:10:35
Chlorhydrate de papaverine [French] - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is dissolved in chloroform, slightly soluble in water, slightly soluble in ethanol, almost insoluble in ether.
Last Update:2022-01-01 15:35:32
Chlorhydrate de papaverine [French] - Differential diagnosis
Authoritative Data Verified Data
- take about 0.1g of this product, add 10ml of water to dissolve, heat to about 50°C, drop a slight excess of ammonia test solution to make it alkaline, stir constantly to precipitate and place it for 5 minutes, after filtration, the precipitate was washed with a small amount of water, dried at 105 ° C. For 1 hour, and measured according to law (General 0612). The melting point was 146 to 148 ° C. As shown in Fig.
- take about 10mg of this product, Add 10ml of water to dissolve, add 3 drops of dilute hydrochloric acid and 5 drops of potassium ferricyanide test solution to generate light yellow precipitate (different from other opioid alkaloids).
- take 5mg of this product, add 1ml of formaldehyde sulfuric acid test solution, the solution should be colorless or light yellow, gradually turning into deep rose red, finally, it becomes purple (morphine or an esterification of morphine is immediately purple or pansy).
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 405).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update:2022-01-01 15:35:32
Chlorhydrate de papaverine [French] - Exam
Authoritative Data Verified Data
acidity
take 0.20g of this product, Add 10ml of water to dissolve it, and determine it according to law (General rule 0631). The pH value should be 3.0~4.0.
color of solution
take 0.2g of this product, add the new boiling and cooling water 10ml after dissolution, and Orange Yellow No. 2 Standard Colorimetric liquid (General Principles 0901 The first method) comparison, not deeper.
Related substances
take this product and dilute it with mobile phase to make a solution containing about 1 mg per 1ml as a test solution. Take 1ml for precision measurement, put it in a 100ml measuring flask, and dilute it to the scale with mobile phase, as a control solution. According to the high performance liquid chromatography (General 0512) test, using eighteen alkyl silane bonded silica gel as filler; With 0.005mol/L sodium heptane sulfonate 0.Olmol /L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid)-methanol (50:50) as mobile phase; The detection wavelength was 250nm; The resolution of papaverine peak and adjacent impurity peaks should meet the requirements, the number of theoretical plates shall not be less than 2000 calculated from the papaverine peak. 20 u1 of each of the control solution and the test solution were injected into the liquid chromatograph respectively, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
easily carbonized
take this product 50mg, add sulfuric acid 2ml dissolved, such as color, and the same volume of the control solution [take potassium permanganate titration solution (0.02mol /L )2ml add water to 1000ml], not deeper.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update:2022-01-01 15:35:33
Chlorhydrate de papaverine [French] - Content determination
Authoritative Data Verified Data
take this product about 0.3g, precision weighing, add glacial acetic acid 30ml 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 titration results were corrected with a blank test.
per 1 ml of perchloric acid titration solution (0.1 mol /L)
Last Update:2022-01-01 15:35:34
Chlorhydrate de papaverine [French] - Category
Authoritative Data Verified Data
Last Update:2022-01-01 15:35:34
Chlorhydrate de papaverine [French] - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 15:35:34
Chlorhydrate de papaverine [French] - Papaverine hydrochloride tablets
Authoritative Data Verified Data
This product contains papaverine hydrochloride (C20H21N04 • HCl) should be 93.0% ~ 107.0% of the label amount.
trait
This product is white tablet.
identification
take an appropriate amount of this product fine powder (about 60mg equivalent to papaverine hydrochloride), add 10ml of water, shake to dissolve papaverine hydrochloride, filter, filtrate under the identification of papaverine hydrochloride (2), (3), (5) the test showed the same response.
examination
- Content uniformity: Take 1 tablet of this product, put it in mortar, grind it with appropriate amount of water, transfer it to 250ml measuring flask with 50ml of water, add 3ml of hydrochloric acid, and shake it for 15 minutes, dilute to scale with water, shake, filter, take the filtrate 1ml accurately, put it in 50ml measuring flask, dilute to scale with water, shake well. According to UV-visible spectrophotometry (General rule 0401 ), the absorbance is measured at a wavelength of 250nm, and the content is calculated according to the law as the absorption coefficient of C20H21N04 • HCl is 1830, the provisions shall be met (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, with 0.1 mol/ L hydrochloric acid solution was quantitatively diluted to prepare a solution containing 2.4ug of papaverine hydrochloride per 1 ml. The absorbance was measured at a wavelength of 0401 NM according to UV-Vis spectrophotometry (General rule 1830), and the elution amount of each tablet was calculated as the absorption coefficient of c20 h21n04-HCl was. 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, precision weighing, fine grinding, precision weighing appropriate amount (about 0.12g equivalent to papaverine hydrochloride), set the separation funnel, add water 20ml, shake, add 7.5ml of ammonia solution, and extract 6 times (30ml, 15ml, 10ml, 10ml, 10ml) with chloroform shaking, after washing with 10ml of the same water, filter with absorbent cotton wetted with chloroform, wash the filter with chloroform twice, 10ml each time, combine the chloroform solution, put the water bath to dry, and add anhydrous ethanol 5ml, dry to dryness, then add 5ml of anhydrous ethanol, dry to no ethanol odor, dry at 105°C for half an hour, add 10ml of glacial acetic acid, shake to dissolve, add 1 drop of crystal violet indicator solution, titrate with perchloric acid titration solution (0.0 5mol /L) until the solution is green, and the titration results are corrected by blank test. Each 1 ml perchloric acid titration solution (0.05mol/L) corresponds to 18.79mg of c20 h21n04. HCl.
category
Same as papaverine hydrochloride.
specification
30mg
storage
light shielding, sealed storage.
Last Update:2022-01-01 15:35:35
Chlorhydrate de papaverine [French] - Papaverine hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of papaverine hydrochloride. Containing papaverine hydrochloride (C20H21NO4 • HCl) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless to light yellow clear liquid.
identification
- 5ml of this product was dried by evaporation on a water bath, and the residue was tested according to item (2) for identification under papaverine hydrochloride, showing the same result.
- 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.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 2.5 to 4.0 (General 0631).
- the color of this product, compared with the yellow 5 standard colorimetric liquid (General Principles 0901 The first method), not deeper.
- Related Substances: take this product and dilute it with mobile phase to make a solution containing about 1 mg per 1ml, which is used as a test solution. Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. If there are impurity peaks in the chromatogram of the test solution, except for the peaks of excipients before the relative retention time of 0.3, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- bacterial endotoxin take this product, according to the law inspection (General 1143), per 1 mg of papaverine hydrochloride containing endotoxin should be less than 2.5 EU.
- sterile take this product, using membrane filtration method, flushing fluid (pH 7.0 sterile sodium chloride-peptone buffer) dosage of not less than 100ml/membrane, with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101 ), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
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; With 0.005mol/L sodium heptane sulfonate 0.Olmol /L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid)-methanol (50:50) as mobile phase; The detection wavelength was 250nm; The resolution of papaverine peak and adjacent impurity peaks should meet the requirements, the number of theoretical plates shall not be less than 2000 calculated from the papaverine peak.
- determination precision: take an appropriate amount of this product and quantitatively dilute it with mobile phase to make a solution containing about 60% of papaverine hydrochloride in each lml, as the test solution, and inject 20ul into human liquid chromatograph for precision measurement, the chromatogram was recorded, and the reference substance of papaverine hydrochloride was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as papaverine hydrochloride.
specification
lml:30mg
storage
light shielding, closed storage.
Last Update:2022-01-01 15:35:36