Romazicon Flumazenil USP 78755-81-4 Antidote Raw Material Powder
1. Flumazenil description:
Flumazenil Product Name: Flumazenil
Flumazenil Synonyms: Ethyl 8-fluoro-5-methyl-6-oxo-5, 6-dihydro-4h-imidazo[1, 5-a][1, 4]benzodiazepine-3-carboxylate; FLUMAZENIL; 8-FLUORO-5, 6-DIHYDRO-5-METHYL-6-OXO-4H-IMIDAZO[1, 5-A][1, 4]BENZO-DIAZEPINE-3-CARBOXYLIC ACID ETHYL ESTER; 8-FLUORO-5, 6-DIHYDRO-5-METHYL-6-OXO-4H-IMIDAZO[1, 5-A][1, 4]BENZODIAZEPINE-3-CARBOXYLIC ACID ETHYL EST; 4H-IMIDAZO[1, 5-A][1, 4]BENZODIAZEPINE-3-CARBOXYLIC ACID, 8-FLUORO-5, 6-DIHYDRO-5-METHYL-6-OXO-, ETHYL ESTER; RO 15-1788; Flumazenil, Flumazepil; FlumazenilUsDmf
Flumazenil CAS: 78755-81-4
Flumazenil MF: C15H14FN3O3
Flumazenil MW: 303.29
Flumazenil EINECS:
Flumazenil Product Categories: Active Pharmaceutical Ingredients; GABA/Glycine receptor; GABA; Amines; Heterocycles; Intermediates & Fine Chemicals; Pharmaceuticals; ZEBETA; Other APIs; Antagonist; API
Flumazenil Mol File: 78755-81-4. Mol
Flumazenil Chemical Properties Colourless crystals
Flumazenil Usage Imidazodiazepine which selectively blocks the central effects of classic benzodiazepines. It is used as benzodiazepine antagonist.
Flumazenil Usage beta-blocker, antihypertensive
Flumazenil Usage benzodiazepine antagonist sedation reversal drug
2. Flumazenil COA
|
Items of analysis |
Specification |
Results |
|
Appearance |
White crystalline powder |
White Crystalline Powder |
|
Identification |
The sample'S IR spectrum is according with spectrum of Flumazenil,The retention time of the major peak Flumazenil in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation |
Conforms |
|
Melting point |
198ºC to 202ºC |
200.6ºC to 200.9ºC |
|
Appearance of solution |
The solution is clear and is not Intenser than reference solution BY7 |
Conforms |
|
Impurity C |
NMT 0.2% |
0.02% |
|
Impurity A |
NMT 0.10% |
Not detected |
|
Impurity B |
NMT 0.2% |
0.03% |
|
Impurity D |
NMT 0.10% |
0.03% |
|
Impurity E |
NMT 0.10% |
Not detected |
|
Impurity F |
NMT 0.10% |
Not detected |
|
Individual unknown impurituy |
NMT 0.10% |
0.02% |
|
Total impurities |
NMT 0.5% |
0.1% |
|
Loss on drying |
NMT 0.5% |
0.2% |
|
Sulphated ash |
NMT 0.1% |
0.05% |
|
Heavy metals |
≤0.5 ppm |
5ppm |
Microbial limits
(for Injection) |
Bacteria not more than 50CFU/g |
<10 CFU/g |
|
Microbial limits |
Mildew and microzyme not more than 50CFU/g |
<10 CFU/g |
|
Microbial limits |
Escherichia coli absence |
Absence |
|
Ethanol |
NMT2000ppm |
Not detected |
|
Chloroform |
NMT30ppm |
Not detected |
|
Acetic acid |
NMT4000ppm |
Not detected |
|
Dichloromethane |
NMT600ppm |
<0.002% |
|
Ethyl ethanoate |
NMT5000ppm |
<0.003% |
|
DMF |
NMT750ppm |
Not detected |
|
Assay (On dried substance) |
98.0-102.0% |
99.80% |
|
Bacterial endotoxins |
not more than 25.0 USP Endotoxin Units per mg of flumazenil. |
not more than 8.0 USP Endotoxin Units per mg of flumazenil. |
|
Guarantees the nature time |
36 months |
36 months |
China (Mainland)
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