VASOMAX
Phentolamine Mesylate
CAS: 65-28-1
Molecular Formula: C18H23N3O4S
VASOMAX - Names and Identifiers
| Name | Phentolamine Mesylate |
| Synonyms | REGITIN VASOMAX REGITIN MESYLATE phentolamine mesilate Phentolamine Mesylate PHENTOLAMINE MESILATE PHENTOLAMINE MESYLATE phenomonomethanesulfonate PHENTOLAMINE METHANESULFONATE phentolaminemethanesulphonate phentolamine methanesulfonate Phentolamine methanesulfonate salt PHENTOLAMINE METHANESULFONATE SALT m-(n-(2-imidazolin-2-ylmethyl)-p-toluidino)- m-(n-(2-imidazolin-2-ylmethyl)-p-toluidino)-phenomonomethanesulfonate(sal |
| CAS | 65-28-1 |
| EINECS | 200-604-6 |
| InChI | InChI=1/C17H19N3O.CH4O3S/c1-13-5-7-14(8-6-13)20(12-17-18-9-10-19-17)15-3-2-4-16(21)11-15;1-5(2,3)4/h2-8,11,21H,9-10,12H2,1H3,(H,18,19);1H3,(H,2,3,4) |
| InChIKey | OGIYDFVHFQEFKQ-UHFFFAOYSA-N |
VASOMAX - Physico-chemical Properties
| Molecular Formula | C18H23N3O4S |
| Molar Mass | 377.46 |
| Density | 1.2256 (rough estimate) |
| Melting Point | 180-182°C(lit.) |
| Boling Point | 551°C at 760 mmHg |
| Flash Point | 287°C |
| Water Solubility | 50 mg/mL |
| Solubility | ethanol: soluble26 mg/mL H2O: soluble50 mg/mL |
| Vapor Presure | 9.48E-13mmHg at 25°C |
| Appearance | powder |
| Color | white to off-white |
| Merck | 14,7264 |
| Storage Condition | 2-8°C |
| Stability | Aq. Solutions Cannot be Stored |
| Refractive Index | 1.6320 (estimate) |
| MDL | MFCD00134201 |
| Use | α-adrenoceptor antagonist; peripheral vascular dilator. |
VASOMAX - Risk and Safety
| 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. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| UN IDs | 3249 |
| WGK Germany | 3 |
| RTECS | SL5430000 |
| HS Code | 29332900 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LDLo scu-rat: 275 mg/kg NIIRDN 6,667,82 |
VASOMAX - Standard
Authoritative Data Verified Data
This product is 3-[[(4, 5-dihydro-1h-imidazol-2-yl) methyl] (4-tolyl) amino] phenol methanesulfonate. Calculated as dry product, containing not less than 99.0% of C17H19N30 • CH403S.
Last Update：2024-01-02 23:10:35
VASOMAX - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is soluble in water or ethanol, slightly soluble in chloroform.
melting point
The melting point of this product (General rule 0612) is 176~181°C, and it is decomposed at the same time during melting.
Last Update：2022-01-01 11:38:57
VASOMAX - Differential diagnosis
Authoritative Data Verified Data
- take about 30mg of this product, add 15ml of water to dissolve it, divide it into three parts, add iodine test solution, potassium iodide test solution and trinitrophenol test solution respectively, and produce brown precipitate, white precipitate and yellow precipitate respectively.
- take 50mg of this product and 0.2g of sodium hydroxide, add several drops of water to dissolve, steam dry with small fire, then slowly heat to melt, continue to heat for several minutes, and let cool, add 0.5ml of water with a slight excess of dilute hydrochloric acid, heating, namely the occurrence of sulfur dioxide gas odor.
- The infrared absorption spectrum of this product should be consistent with that of the reference substance phentolamine mesylate (General rule 0402).
Last Update：2022-01-01 11:38:58
VASOMAX - Exam
Authoritative Data Verified Data
pH
take 0.10g of this product, Add 10ml of water to dissolve, add 1 drop of Methyl red indicator liquid, should be red; Add sodium hydroxide titration solution (0.lmol/L)0.05, should become yellow.
chloride
take 0.10g of this product, add 5M l of water and 1ml of dilute nitric acid, warm to 80°C, add 1ml of silver nitrate test solution, and no white turbidity.
Related substances
take about 10mg of this product, put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, and use it as a test solution. Take 1 ml 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. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 5 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%). The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
residual solvent
take an appropriate amount of this product, precision weighing, add an appropriate amount of N, N-dimethylformamide, immediately shake to dissolve and dilute to make about 0 per lml. lg solution, as the test solution; Another precision weighing methanol, ethanol, ethyl acetate and xylene appropriate amount, add N, N-dimethylformamide was dissolved and diluted to prepare a solution containing 0.3mg of toluene, 0.5mg of ethanol, 0.5mg of ethyl acetate and 0.217mg of xylene per 1 ml as a control solution. According to the determination method of residual solvent (General 0861 third method), 100% dimethyl polysiloxane is used as stationary liquid; The starting temperature is 40°C, and the temperature is raised to 80°C at the rate of 15 * C per minute for 5 minutes, then, the temperature is raised to 130°C at a rate of 6°C per minute for 1 minute, and then raised to 220°C at a rate of 40°C per minute for 3 minutes; The temperature of the injection port is 200°C; the detector temperature was 250°C. Take 1ul of reference solution and inject it into human gas chromatograph, and the separation degree between peaks of each component shall meet the requirements. 1 u1 of the test solution and the reference solution were respectively injected into the human Gas Chromatograph. The chromatogram was recorded and the peak area was calculated according to the external standard method. Methanol, ethanol, ethyl acetate and xylene residues shall 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
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 11:38:59
VASOMAX - 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 as a filler; 0.Olmol/L heptane sulfonate solution (containing 0. 1% triethylamine, adjusted to pH 3.0 with phosphoric acid)-acetonitrile (64:36) as mobile phase; The detection wavelength was 278nm. Take about 25mg of phentolamine mesylate reference substance, put it in a 25ml measuring flask, add 0.05 ml of 0.5 mol/L sodium hydroxide solution, and place it for 24 hours to degrade part of phentolamine mesylate into impurity I, 0.5ml of 0.05mol/L hydrochloric acid solution was added and neutralized, diluted with mobile phase to scale, and then shaken, and 20u1 of the solution was injected into human liquid chromatograph, the degree of separation between the phentolamine peak and the impurity I Peak (the main degradation product adjacent to the phentolamine peak is impurity I) shall be satisfactory. The number of theoretical plates is not less than 3000 calculated from the phentolamine peak.
assay
take about 25mg of this product, precision weighing, put in 25ml measuring flask, add water to dissolve and dilute to the scale, shake, take 5ml precision, put in 50ml measuring flask, dilute to scale with water, shake well, take 20 u1 with precision, inject human liquid chromatograph, record chromatogram; Take phentolamine mesylate reference substance, and determine with the same method. According to the external standard method, the peak area of phentolamine was calculated.
Last Update：2022-01-01 11:38:59
VASOMAX - Category
Authoritative Data Verified Data
a adrenergic receptor blockers.
Last Update：2022-01-01 11:39:00
VASOMAX - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:39:00
VASOMAX - PhentolamineMesylateTablets
Authoritative Data Verified Data
This product contains phentolamine mesylate (C17H19N30 • CH403S) should be 93.0% ~ 107.0% of the label amount.
trait
This product is white or white-like tablets or orange-red tablets or film-coated tablets with colorants, white or white-like after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 30mg equivalent to phentolamine mesylate), add 15ml of water, dissolve with shaking, filter, and divide the filtrate into three parts, add iodine test solution, potassium iodide test solution and trinitrophenol test solution respectively, A brown precipitate, a white precipitate and a yellow precipitate were generated, respectively.
- take an appropriate amount of fine powder of this product (about 50mg equivalent to phentolamine mesylate) and 0.2g of sodium hydroxide, add several drops of water to dissolve, evaporate to dryness with small fire, slowly heat to melt, continue to heat for several minutes, and cool, add 0.5ml of water with a slight excess of dilute hydrochloric acid, heating, namely the occurrence of sulfur dioxide gas odor.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of 278nm.
- 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
- Related substances appropriate amount of fine powder of this product (about 10mg equivalent to phentolamine mesylate) was placed in a 10ml measuring flask, and the mobile phase was added to dissolve and dilute to the scale, shake and filter, the continuous filtrate was taken as the test solution; 1ml of the test solution was accurately measured, placed in a 100ml measuring flask, diluted to the scale with the mobile phase, and shaken to serve as a control solution. According to the chromatographic conditions under the content determination item, 20Mk of the test solution and the control solution are respectively injected into the human liquid chromatograph, and the chromatogram is recorded to 5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity I peak shall not be greater than the main peak area of the control solution (1.0% ) , the Peak area of other single impurity peaks shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of the peak areas of each impurity shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The sample solution chromatogram is smaller than the dissolution of the main peak area of the control solution. According to the dissolution and release determination method (the first method of the general rule 0931), water 1000ml is used as the dissolution medium, the rotation speed is 50 rpm, and the operation is carried out according to law. After 15 minutes, the appropriate amount of the solution is taken, filtered, and the appropriate amount of the filtrate is taken, the solution containing about 20ug phentolamine mesylate per 1ml was prepared by quantitative dilution with dissolution medium. The absorbance was measured at the wavelength of 278mn by UV-Vis spectrophotometry (General rule 0401), precision weighing, dissolution and quantitative dilution of dissolution medium to prepare about 20% solution per 1 ml, the same method to determine, calculate the dissolution of each tablet. The limit is 80% 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.01mol/L sodium heptane sulfonate solution (containing 0.1% triethylamine, adjusted to pH 3.0 with phosphoric acid)-Acetonitrile (64:36) as mobile phase; The detection wavelength was 278nm. Take about 25mg of phentolamine mesylate reference substance, put it in a 25ml measuring flask, add 0.05 ml of 0.5 mol/L sodium hydroxide solution, and place it for 24 hours to degrade part of phentolamine mesylate into impurity I, add 0.05mol/L hydrochloric acid solution (ml), dilute to the scale with mobile phase, shake, and use 20u1 to inject human liquid chromatograph as the applicable solution for the system, the degree of separation between the phentolamine peak and the impurity I Peak (the main degradation product adjacent to the phentolamine peak is impurity I) shall be satisfactory. The number of theoretical plates is not less than 3000 calculated from the phentolamine peak.
- determination: take an appropriate amount of fine powder of this product (about 25mg equivalent to phentolamine mesylate), weigh it accurately, put it in a 25ml measuring flask, add water to dissolve phentolamine mesylate and dilute it to the scale, shake it well and filter it, precisely take 5ml of continuous filtrate, put it in 50ml measuring flask, dilute it to scale with water, shake well, use it as sample solution, precisely take 20 u1, inject human liquid chromatograph, record chromatogram; take an appropriate amount of phentolamine mesylate reference substance, weigh it precisely, add water to dissolve and quantitatively dilute it to make it contain about 0 in 1 ml. lmg solution, the same method for determination. According to the external standard method, the peak area of phentolamine was calculated.
category
Same as phentolamine mesylate.
specification
(l)40mg (2)50mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:39:01
VASOMAX - Phentolamine Mesilate Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of phentolamine mesylate plus 5% dextrose. Containing phentolamine mesylate (C17H19N3O • CH4O3S) shall be between 95.0% and 105.0% of label load.
trait
This product is colorless to yellowish clear liquid.
identification
- take about 3ml of this product, add 12ml of water to dilute, according to phentolamine mesylate under the item of identification (1) test, showed the same reaction.
- 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
- the pH value should be 2.5 to 5.0 (General 0631).
- relevant substances: take an appropriate amount of this product (about equivalent to 10 mg of phentolamine mesylate), put it in a 10ml measuring flask, dilute it with mobile phase until it is calibrated, shake well, and use it as a test solution, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. If there are impurity peaks in the chromatogram of the test solution, the sum of the area of each impurity peak shall not be greater than 2.5 times (2.5%) of the area of the main peak of the control solution. The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
- bacterial endotoxin this product, according to the law inspection (General 1143), per 1 mg phentolamine mesylate in the amount of endotoxin should be less than 5.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take an appropriate amount of this product (about 10mg equivalent to phentolamine mesylate), put it in a 100ml measuring flask, dilute it to the scale with water, shake it well, and use it as a test solution, according to phentolamine mesylate content determination method under the item of determination, obtained.
category
Same as phentolamine mesylate.
specification
(l)lml:5mg (2)lml:lOmg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:39:02
VASOMAX - Phentolamine mesylate capsules
Authoritative Data Verified Data
This product contains phentolamine mesylate (C17H19N3O • CH4O3S) should be 93.0% ~ 107.0% of the label amount.
trait
The content of this product is white powder.
identification
- take an appropriate amount of the content of this product (about 30mg equivalent to phentolamine mesylate), add 15ml of water, shake and dissolve, filter, and divide the filtrate into three parts, add iodine test solution, potassium iodide test solution and trinitrophenol test solution respectively, A brown precipitate, a white precipitate and a yellow precipitate were generated, respectively.
- take an appropriate amount of the contents of this product (about 50mg equivalent to phentolamine mesylate) and 0.2g of sodium hydroxide, add a few drops of water to dissolve, evaporate to dryness with small fire, slowly heat to melt, continue heating for several minutes, and cool, add 0.5ml of water with a slight excess of dilute hydrochloric acid, heating, namely the occurrence of sulfur dioxide gas odor.
- the solution under the content measurement was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of 278nm.
- 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
- take the content of the related substances under the content determination item, weigh an appropriate amount (about 10mg equivalent to phentolamine mesylate) accurately, put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, filter and take the filtrate as the test solution; Take 1ml of the test solution accurately, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake well, and use as the control solution. According to the chromatographic conditions under the content determination item, the test solution and the control solution are 20M1 respectively, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity I peak shall not be greater than the main peak area of the control solution (1.0%), the Peak area of other single impurity peaks shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of the peak areas of each impurity shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method>, with water 1000ml as the dissolution medium, the speed is 50 rpm, according to the law, after 15 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, dilute quantitatively with dissolution medium to make a solution containing about 20ug of phentolamine mesylate per lml, according to UV-Vis spectrophotometry (General rule 0401), measure absorbance at 278nm wavelength; Take appropriate amount of phentolamine mesylate reference, the dissolution medium is added to dissolve and quantitatively dilute to prepare a solution containing about 20ug per 1 ml, which is determined by the same method, and the dissolution amount of each particle is calculated. 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; 0.Olmol/L sodium heptane sulfonate solution (containing 0.1% triethylamine, adjusted to pH 3.0 with phosphoric acid)-acetonitrile (64:36) as mobile phase; The detection wavelength was 278nm. Take about 25mg of phentolamine mesylate reference substance, put it in a 25ml children's bottle, add 0.05 ml of 0.5 mol/L sodium hydroxide solution, and place it for 24 hours to degrade part of phentolamine mesylate into impurity I, add 0.05mol/L hydrochloric acid solution in ML, dilute to the scale with mobile phase, shake well, and use 20u1 to inject human liquid chromatograph, the degree of separation between the phentolamine peak and the impurity I Peak (the main degradation product adjacent to the phentolamine peak is impurity I) shall be satisfactory. The number of theoretical plates is not less than 3000 calculated from the phentolamine peak.
- determine the contents under the item of loading difference, mix evenly, weigh an appropriate amount (about 25mg of phentolamine mesylate) accurately, and put it in a 25ml measuring flask, add water to dissolve phentolamine mesylate and dilute to the scale, shake well, filter, Take 5ml of continued filtrate precisely, put it in a 50ml measuring flask, dilute to the scale with water, shake well, as a test solution, take 20ul with precision, inject human liquid chromatograph, record chromatogram; Take appropriate amount of phentolamine mesylate reference substance, weigh accurately, add water to dissolve and quantitatively dilute to make about 0 in 1 ml. lmg solution, the same method for determination. According to the external standard method, the peak area of phentolamine was calculated.
category
Same as phentolamine mesylate.
specification
40mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:39:03
VASOMAX - Phentolamine mesylate for injection
Authoritative Data Verified Data
This product is a sterile freeze-dried product made of phentolamine mesylate plus an appropriate amount of mannitol. Containing phentolamine mesylate (C17H19N3O • CH4O3S) shall be between 90.0% and 110.0% of label load.
trait
This product is a loose mass or powder from white to off-white.
identification
- take about 30mg of this product, add 15ml of water to dissolve it, divide it into three parts, add iodine test solution, potassium iodide test solution and trinitrophenol test solution respectively, and produce brown precipitate, white precipitate and yellow precipitate respectively.
- 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
- acidity 5 bottles of this product, each bottle of water lml dissolved, combined, measured according to law (General 0631 ),pH value should be 4.5~6.5.
- relevant substances: take an appropriate amount of this product (about 10 mg of phentolamine mesylate), put it in a 10ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, and use it as a test solution; take 1ml of precision, 100ml flask, diluted with mobile phase to scale, shake, as a control solution. If there are impurity peaks in the chromatogram of the test solution, the area of impurity I peak shall not be greater than the area of the main peak of the control solution (1.0%), other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.02 times smaller than the main peak area of the control solution.
- Content uniformity one bottle of this product was added with water to dissolve phentolamine mesylate and quantitatively diluted to prepare a solution containing about 0.1 mg of phentolamine mesylate per 1 ml as a test solution. Determination of phentolamine mesylate content according to the method under the item, should comply with the provisions (General 0941).
- bacterial endotoxin this product, according to the law inspection (General 1143), per 1 mg phentolamine mesylate in the amount of endotoxin should be less than 5.0EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The average value of the measurement results under the content uniformity is obtained.
category
Same as phentolamine mesylate.
specification
1Omg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:39:04
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