78755-81-4 - Names and Identifiers
Name | Flumazenil
|
Synonyms | FMZ RO15-1788 FLUMAZENIL RO 15-1788 Ro 15-1788 Flumazenil FluMazenil USP ethyl 8-fluoro-5-methyl-6-oxo-5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate ethyl 8-fluoro-5-methyl-6-oxo-5,6-dihydro-4h-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate 8-FLUORO-5,6-DIHYDRO-5-METHYL-6-OXO-4H-IMIDAZO[1,5-A][1,4]BENZODIAZEPINE-3-CARBOXYLIC ACID ETHYL EST 8-FLUORO-5,6-DIHYDRO-5-METHYL-6-OXO-4H-IMIDAZO[1,5-A][1,4]BENZO-DIAZEPINE-3-CARBOXYLIC ACID ETHYL ESTER 4H-IMIDAZO[1,5-A][1,4]BENZODIAZEPINE-3-CARBOXYLIC ACID, 8-FLUORO-5,6-DIHYDRO-5-METHYL-6-OXO-, ETHYL ESTER 8-Fluoro-5,6-dihydro-5-methyl-6-oxo-4H-
Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic
acid ethyl ester
|
CAS | 78755-81-4
|
EINECS | 616-650-9 |
InChI | InChI=1/C15H14FN3O3/c1-3-22-15(21)13-12-7-18(2)14(20)10-6-9(16)4-5-11(10)19(12)8-17-13/h4-6,8H,3,7H2,1-2H3 |
78755-81-4 - Physico-chemical Properties
Molecular Formula | C15H14FN3O3
|
Molar Mass | 303.29 |
Density | 1.39±0.1 g/cm3(Predicted) |
Melting Point | 201-203°C |
Boling Point | 528.0±50.0 °C(Predicted) |
Flash Point | 273.1°C |
Water Solubility | 128 mg/L |
Solubility | Soluble in DMSO to 25mM |
Vapor Presure | 3.1E-11mmHg at 25°C |
Appearance | solid | white |
Color | white |
Merck | 14,4135 |
pKa | 0.86±0.20(Predicted) |
Storage Condition | Sealed in dry,2-8°C |
Stability | Stable for 2 years from date of purchase as supplied. Solutions in DMSO may be stored at -20°C for up to 3 months. |
Refractive Index | 1.633 |
MDL | MFCD00242764 |
Physical and Chemical Properties | Crystallization in alcohol, melting point 20l ~ 203 deg C. Acute toxicity LD50 mice, rats (mg/kg):4000,1360 intraperitoneal injection; 4300,6000 oral. |
78755-81-4 - Risk and Safety
Hazard Symbols | Xi - Irritant
|
Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin.
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Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S27 - Take off immediately all contaminated clothing.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
|
WGK Germany | 2 |
RTECS | NI2922170 |
HS Code | 2933997500 |
Toxicity | LD50 in mice, rats (mg/kg): 4000, 1360 i.p.; 4300, 6000 orally (Hunkeler) |
78755-81-4 - Standard
Authoritative Data Verified Data
This product is 8-fluoro-5, 6-dihydro-5-methyl-6-oxo-4h-imidazo-[1,5-a][1,4] benzodiazepane-3-carboxylic acid ethyl ester. Calculated as dry product, containing no less than 99.0% of C15H14FN3O3.
Last Update:2024-01-02 23:10:35
78755-81-4 - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is soluble in chloroform or glacial acetic acid, slightly soluble in methanol, almost insoluble in water.
melting point
The melting point of this product (General rule 0612 first method) is 198~202°C, and it is decomposed at the same time during melting.
Last Update:2022-01-01 13:40:22
78755-81-4 - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, Dropwise add glacial acetic acid to make it just soluble, add dilute bismuth potassium iodide solution to generate orange red precipitate.
- This product is dissolved in methanol and diluted to make a solution containing 4ug per lml, which is determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at a wavelength of 244Nm and a minimum absorption at a wavelength of 227nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 993).
- This product shows the identification reaction of organic fluoride (General rule 0301).
Last Update:2022-01-01 13:40:23
78755-81-4 - Exam
Authoritative Data Verified Data
clarity and color of acetic acid solution
take this product 0.lg, add acetic acid 10ml after dissolution, the solution should be clear and colorless.
Related substances
The product was taken, and the mobile phase was added to make a test solution containing 1.0 mg per 1 ml and a control solution containing 10ug per 1 ml. Test according to high performance liquid chromatography (General 0512). Silica gel bonded with eighteen alkyl silane was used as filler; Dilute phosphoric acid solution (2.0 of water was taken, pH was adjusted to with phosphoric acid)-methanol-tetrahydrofuran (80:13:7) was used as mobile phase; the detection wavelength was 230nm. The number of theoretical plates shall not be less than 3000 based on the flumazenil peak. 20ul of control solution and 20ul of test solution were respectively injected into human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of principal 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 0.2 times (0.2%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.2% (General rule 0831).
ignition residue
take 1.0g of this product, put it in a platinum crucible, 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 taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update:2022-01-01 13:40:23
78755-81-4 - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, add glacial acetic acid 30ml and acetic anhydride 20ml dissolved, according to the potential titration method (General rule 0701), with perchloric acid titration solution (O. 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 30.33mg of C15H14FN3O3.
Last Update:2022-01-01 13:40:24
78755-81-4 - Category
Authoritative Data Verified Data
benzodiazepine antagonists.
Last Update:2022-01-01 13:40:24
78755-81-4 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 13:40:25
78755-81-4 - Flumazenil Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of flumazenil. The fluorine-containing Masini (C15H14FN3O3) shall be 90.0%-110.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
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 control solution.
examination
- the pH value should be 3.5 to 4.2 (General 0631).
- Related substances this product was taken as a test solution; An appropriate amount was taken in a precise amount, and water was added for quantitative dilution to prepare a solution containing about 1 ton of fluorine-containing Masini per 1 ml, which was used as a control solution. The determination was carried out according to the method for related substances of clemazini. 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 (1.0%), 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.
- bacterial endotoxin take this product, according to the law inspection (General 1143), the amount of endotoxin per 1 mg flumazenil should be less than 25EU.
- 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; Dilute phosphoric acid solution (1000ml of water, adjusted to pH 2.0 with phosphoric acid)-methanol-tetrahydrofuran (80:13:7) as mobile phase; Detection wavelength, 230nm. The number of theoretical plates shall not be less than 3000 based on the flumazenil peak.
- determination of this product, as a test solution, the precise amount of 20u1 injection of human liquid chromatography, record the chromatogram; Another flumazenil reference product about 20mg, precise weighing, in a 200ml measuring flask, add 20ml of methanol, shake to dissolve, dilute to the scale with water, shake well, and measure with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as flumazenil.
specification
(l)2ml:0.2mg (2)5ml:0.5mg (3)10ml:1.Omg
storage
protected from light and sealed.
Last Update:2022-01-01 13:40:25