RAMANTADINE HYDROCHLORIDE
1-(1-adamantyl)ethylamine hydrochloride
CAS: 1501-84-4
Molecular Formula: C12H22ClN
RAMANTADINE HYDROCHLORIDE - Names and Identifiers
| Name | 1-(1-adamantyl)ethylamine hydrochloride |
| Synonyms | ROFLUAL MERADANE FLUMADINE Rimantadine HCl IFLAB-BB F1386-0449 Rimantadine hydrochloride RAMANTADINE HYDROCHLORIDE 1-Adamantane ethylamine hydrochloride 1-(1-ADAMANTYL)ETHANAMINE HYDROCHLORIDE 1-(1-ADAMANTYL)ETHYLAMINE HYDROCHLORIDE 1-(1-adamantyl)ethylamine hydrochloride 1-(1-aminoethyl)adamantane hydrochloride ALPHA-METHYL-1-ADAMANTANEMETHYLAMINE HYDROCHLORIDE |
| CAS | 1501-84-4 |
| EINECS | 604-725-9 |
| InChI | InChI=1/C12H21N.ClH/c1-8(13)12-5-9-2-10(6-12)4-11(3-9)7-12;/h8-11H,2-7,13H2,1H3;1H |
| InChIKey | OZBDFBJXRJWNAV-UHFFFAOYSA-N |
RAMANTADINE HYDROCHLORIDE - Physico-chemical Properties
| Molecular Formula | C12H22ClN |
| Molar Mass | 215.76 |
| Melting Point | >300°C(lit.) |
| Boling Point | 247.8°C at 760 mmHg |
| Flash Point | 99.3°C |
| Water Solubility | Freely soluble in water. |
| Solubility | Chloroform (Slightly), DMSO (Slightly, Heated), Methanol (Slightly), Water (Slig |
| Vapor Presure | 0.0251mmHg at 25°C |
| Appearance | White crystal |
| Color | White to Off-White |
| Merck | 14,8224 |
| Storage Condition | Inert atmosphere,Room Temperature |
| MDL | MFCD00072023 |
| Physical and Chemical Properties | White crystalline powder. Soluble in ethanol, chloroform or water. Melting point 373-37513 (sealed tube). |
| Use | Anti-Virus, for infections caused by influenza A strain Virus |
RAMANTADINE HYDROCHLORIDE - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful 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. |
| WGK Germany | 3 |
| RTECS | AU4717000 |
| HS Code | 29213000 |
| Toxicity | LD50 oral in rat: 640mg/kg |
RAMANTADINE HYDROCHLORIDE - Standard
Authoritative Data Verified Data
This product is a-methyl tricyclo [3.3.1.13 '7] decane-1-methylamine hydrochloride. Calculated as dry product, containing C12H21N • HCl shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
RAMANTADINE HYDROCHLORIDE - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is soluble in fermentation broth, soluble in water or ethanol.
Last Update：2022-01-01 15:06:29
RAMANTADINE HYDROCHLORIDE - Differential diagnosis
Authoritative Data Verified Data
- take 0.lg of this product, add 2ml of sodium hydroxide solution, shake to make oil beads, add 2ml of chloroform to extract, take 1ml of three-gas methane layer, add 2%, 4-dinitrochlorophenyltrichloromethane solution (1ml) was yellow within 10 minutes.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product can identify the reaction of (1) (General rule 0301).
Last Update：2022-01-01 15:06:30
RAMANTADINE HYDROCHLORIDE - Exam
Authoritative Data Verified Data
acidity
take 0.2g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 4.5~6.5.
clarity and color of solution
take 0.2g of this product and add 20ml of water to dissolve. The solution should be clear and colorless. In case of color development, it shall not be deeper in comparison with the yellow No. 1 Standard Colorimetric solution (General rules 0901 first method).
sulfate
take 1.0g of this product and check it according to law (General rule 0802). Compared with the control solution made of 5.0 ml of standard potassium sulfate solution, it shall not be deeper (0.05%).
ammonium salt
take 2.5g of this product, put it in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake well, take 2ml, add 2ml of sodium hydroxide solution, shake to make it into oil beads, add 2ml of chloroform for extraction, stand for about 5 minutes, take 2ml of water layer, check according to law (General rule 0808), from "add ammonia-free distilled water to 50ml", with standard gasification ammonium solution 2.0ml of the control solution prepared as described above should not be deeper (0.08%).
Related substances
take about 40mg of this product, put it in a separatory funnel, add 10ml of 1 mol/L sodium hydroxide solution, shake it to make it into oil beads, add 10ml of n-hexane precisely, shake it for extraction, and let it stand for stratification, the n-hexane layer was taken as a test solution; An appropriate amount was taken in a precise amount, and quantitatively diluted with n-hexane to prepare a solution containing about 40ug per 1 ml, and the solution was shaken to serve as a control solution. According to the gas chromatography (General 0521) test, the capillary column with 5% phenyl-95% methyl polysiloxane (or similar polarity) as the stationary liquid is the column; The column temperature is 150°C; the inlet temperature was 220°C; The detector temperature was 250°C. 2ul of test solution and 2ul of control solution were respectively injected into human gas chromatograph, and the chromatogram was recorded to 3 times of the retention time of 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%).
residual solvent
take about lg of this product, accurately weigh it, put it in a 10ml measuring flask, add methanol to dissolve and dilute it to the scale, shake it well, and use it as a test solution; in addition, an appropriate amount of toluene was accurately weighed and quantitatively diluted with methanol to prepare a solution containing about 0.089mg per 1 ml, and the solution was shaken to be used as a reference solution. According to the determination method of residual solvent (General rule 0861 third method), the capillary column with polyethylene glycol (PE020M)(or similar polarity) as stationary liquid is used as the column; The column temperature is 40°C; the inlet temperature was 220°C; The detector temperature was 200°C. The sample solution and the reference solution are respectively 2u1 and injected into human gas chromatograph respectively, and the chromatogram is recorded. According to the external standard method to calculate the peak area, the residual amount of toluene should comply 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 1.0g 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).
arsenic salt
take 2.0g of this product, add l.Og of calcium hydroxide, put it in a quartz crucible, add a small amount of water, stir it evenly, dry it, and check it according to law (the first method of general rule 0822), and must not pass 0.0001%.
Last Update：2022-01-01 15:06:31
RAMANTADINE HYDROCHLORIDE - Content determination
Authoritative Data Verified Data
take this product 0.15g, precision weighing, add chloroform 2ml dissolved, add glacial acetic acid 30ml and Mercury acetate test solution 7ml, add crystal violet indicator solution 1 drop, with perchloric acid titration solution (O. 1 mol/L) titration to the solution shows blue color, and the titration result is corrected with blank test. Each 1 ml of high-gas acid titrant (0.1 mol/L) corresponds to 21.58mg of C12H21N-HCl.
Last Update：2022-01-01 15:06:32
RAMANTADINE HYDROCHLORIDE - Category
Authoritative Data Verified Data
antiviral drugs.
Last Update：2022-01-01 15:06:32
RAMANTADINE HYDROCHLORIDE - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 15:06:32
RAMANTADINE HYDROCHLORIDE - Rimantadine hydrochloride tablets
Authoritative Data Verified Data
This product contains rimantadine hydrochloride (C12H21N • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is a white tablet or film-coated tablet, White after removing the coating.
identification
- take the product, remove the coating, triturate, weigh an appropriate amount (approximately equivalent to 0.lg of rimantadine hydrochloride), shake with 10ml of ethanol, filter, and evaporate the filtrate to dryness. Add 2ml of sodium hydroxide solution to the residue, shake to make it into oil beads, add 2ml of trichloromethane to extract, take 1ml of trichloromethane layer, and add 1ml of 2% 2, 4-dinitrochlorobenzene trichloromethane solution, yellow color was noted within 10 minutes.
- take 1 tablet of this product, grind it, add dichloromethane 20ml to dissolve rimantadine hydrochloride, filter it, and evaporate it. The infrared absorption spectrum of the residue should be consistent with that of the reference substance of rimantadine hydrochloride (General rule 0402).
- take an appropriate amount of fine powder of this product (about equivalent to rimantadine hydrochloride O.lg), add 10ml of water, shake, filter, filtrate chloride identification (1) reaction (General 0301).
examination
- Related substances take this product (film-coated tablets are removed from coating), grind it finely, weigh an appropriate amount (about 0.2g equivalent to rimantadine hydrochloride), put it in a 25ml measuring flask, and add an appropriate amount of water, fully shake to dissolve, dilute to the scale with water, shake well, filter, Take 5ml of continuous filtrate accurately, put it in the separating funnel, Add 10ml of 1 mol/L sodium hydroxide solution, shake, the sample was extracted by shaking with 10ml of human n-hexane, and layered by standing. The n-hexane layer was taken as the sample solution, as a control solution. The determination was carried out according to the method for related substances of rimantadine hydrochloride. 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%).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 500ml as the dissolution medium, the speed of 50 rpm, according to the law, after 30 minutes, take 10ml of solution, filter, take 2ml of filtrate accurately, add 5ml of 1 mol/L sodium hydroxide solution, shake, add internal standard solution (take appropriate amount of adamantane, N-hexane was added, dissolved and diluted to prepare a solution containing about 0.35mg per 1 ml) 1 ml was extracted, and the mixture was allowed to stand and layered, and the n-hexane layer was taken as a test solution. Separately take the rimantadine hydrochloride reference substance, precision weigh, add the appropriate amount of methanol to dissolve and dilute quantitatively with the dissolution medium to make a solution containing about 0.2mg per 1 ml, take 2ml precisely, the same method was used as the reference solution from "5ml of 1 mol/L sodium hydroxide solution was added. The capillary column with 5% phenyl -0521 methyl polysiloxane (or similar polarity) as the stationary liquid is the column as determined by gas chromatography (General rule 95%); The column temperature is 150 ℃; the inlet temperature is 220°C; The detector temperature is 250°C, and 2ul of each of the above two solutions is accurately measured, respectively injected into the human gas chromatograph, and the chromatogram is recorded, the dissolution amount of each tablet was calculated by the peak area according to the internal standard method. 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
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to 0.6g of rimantadine hydrochloride), put it in a 100ml measuring flask, add 70ml of anhydrous ethanol, shake to dissolve rimantadine hydrochloride, dilute to the scale with absolute ethanol, shake well, filter, take 25ml of continued filtrate precisely, evaporate on a water bath, dry at 105°C for 10 minutes, and let cool, add 2ml of chloroform to dissolve, Add 30ml of glacial acetic acid and 7ml of Mercury acetate, add 1 drop of crystal violet indicator solution, and use perchloric acid titration solution (0.1 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 21.58mg of C12H21N-HCl.
category
Same as rimantadine hydrochloride.
specification
O.lg
storage
sealed storage.
Last Update：2022-01-01 15:06:33
RAMANTADINE HYDROCHLORIDE - Rimantadine Hydrochloride Granules
Authoritative Data Verified Data
This product contains rimantadine hydrochloride (C12H21N • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or white particles.
identification
- take an appropriate amount of this product (about 0.lg equivalent to rimantadine hydrochloride), add 5ml of sodium hydroxide solution, shake to dissolve rimantadine hydrochloride, add 2ml of chloroform to extract, take 1ml of chloroform layer, add 2%, 4-dinitrochlorophenyltrichloromethane solution (1ml) was yellow within 10 minutes.
- take the contents of 1 bag of this product, grind it, add methylene chloride 20ml to dissolve rimantadine hydrochloride, filter, evaporate, and the infrared absorption spectrum of the residue should be consistent with the spectrum of the reference substance of rimantadine hydrochloride (General 0402).
- take an appropriate amount of the content of this product (about equivalent to rimantadine hydrochloride O.lg), add water of 10 ml, shake, filter, filtrate chloride identification (1) reaction (General 0301).
examination
- the contents under the item of difference in loading amount of related substances should be mixed evenly, weigh an appropriate amount (equivalent to 0.2g of rimantadine hydrochloride), put it in a 25ml measuring flask, and add an appropriate amount of water, fully shake to dissolve, dilute to the scale with water, shake well, filter, Take 5ml of continuous filtrate accurately, put it in the separating funnel, Add 10ml of 1 mol/L sodium hydroxide solution, shake, the sample was extracted by shaking with 10ml of human n-hexane, and layered by standing. The n-hexane layer was taken as the sample solution, as a control solution. The determination was carried out according to the method for related substances of rimantadine hydrochloride. 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%).
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
Take 20 bags of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 0.6g equivalent to rimantadine hydrochloride), put it in a 100ml measuring flask, add 70ml of anhydrous ethanol, shake to dissolve rimantadine hydrochloride, dilute to the scale with absolute ethanol, shake well, filter, take 25ml of continued filtrate precisely, evaporate on a water bath, dry at 105°C for 10 minutes, and let cool, add 2ml of chloroform to dissolve, Add 30ml of glacial acetic acid and 7ml of Mercury acetate test solution, add 1 drop of crystal violet indicator solution, and use perchloric acid titration solution (0.1 mol/L) titration to a blue color of the solution, and the results of the titration were corrected by a blank test. Per 1 ml of perchloric acid titrant (0.1 mol/L) corresponds to 21.58mg of C12H21N • HCl.
category
Same as rimantadine hydrochloride.
specification
(l)50mg (2)100mg
storage
sealed storage.
Last Update：2022-01-01 15:06:34
RAMANTADINE HYDROCHLORIDE - Reference Information
| Target | Value |
| use | antiviral drugs. It works early in the viral replication cycle by inhibiting the dehulling of viral particles within the host cell. It is used to prevent infection caused by influenza A virus strain. Antiviral drugs, used for infection caused by influenza A virus strain Used to synthesize antiviral drug intermediates |
| Production method | Production method Adamantadane bromide is added to ethylene bromide under the catalysis of aluminum tribromide. The product and potassium hydroxide are heated to eliminate two molecules of hydrogen bromide to obtain acetylene. Under the catalysis of mercury oxide, hydrate with sulfuric acid to obtain ketone, then form oxime with hydroxylamine, and finally reduce with lithium aluminum hydride (or catalytic hydrogenation under Pd/C) to obtain rimantadine. |
| category | toxic substances |
| toxicity classification | poisoning |
| acute toxicity | oral administration-rat LD50: 640 mg/kg; Abdominal cavity-mouse LD50: 135 mg/kg |
| flammability hazard characteristics | combustible; combustion produces toxic nitrogen oxides and hydrogen chloride smoke |
| storage and transportation characteristics | warehouse ventilation and low temperature drying |
| fire extinguishing agent | dry powder, foam, sand, carbon dioxide, mist water |
Last Update：2024-04-09 02:00:07
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View History
RAMANTADINE HYDROCHLORIDE
反式巴豆酸
PHENYLOXYL ACETIC ACID
3-Hexene, 2,5-dimethoxy-2,5-dimethyl-, (Z)- (9CI)
Tin(II) chloride dihydrate, For analysis ACS
叔丁基硫醚
4-(BROMOMETHYL)TETRAHYDROPYRAN4-溴甲基四氢吡喃
反式巴豆酸
PHENYLOXYL ACETIC ACID
3-Hexene, 2,5-dimethoxy-2,5-dimethyl-, (Z)- (9CI)
Tin(II) chloride dihydrate, For analysis ACS
叔丁基硫醚
4-(BROMOMETHYL)TETRAHYDROPYRAN4-溴甲基四氢吡喃