BGC > Product Search > Flumazenil | 78755-81-4

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
Melting point	198~202℃
Appearance of solution	The solution is clear and is not intenser than reference solution BY7
Impurity C	≤ 1.0%
Related substances
Known impurities
Impurity A	≤ 0.10%
Impurity B	≤ 0.2%
Impurity D	≤ 0.10%
Impurity E	≤ 0.10%
Impurity F	≤ 0.10%
Individual unknown impurity	≤ 0.10%
Total impurities	≤ 0.2%
Loss on drying	≤ 0.5%
Sulphated ash	≤ 0.1%
Heavy metals	≤ 20ppm
Bacterial endotoxings (for injection)	≤ 0.56EU/mg
Microbial limits (for injection)
Bacteria	not more than 50CFU/g
Mildew and microzyme	not more than 50CFU/g
Escherichia coli	absence
Residual solvents
Ethanol	≤ 2000ppm
Chloroform	≤ 30pm
Acetic acid	≤ 4000ppm
DMF	≤ 750ppm
Assay (on dried substance)	99.0~101.0%

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
Melting point	198~202℃
Appearance of solution	The solution is clear and is not intenser than reference solution BY7
Impurity C	≤ 1.0%
Related substances
Known impurities
Impurity A	≤ 0.10%
Impurity B	≤ 0.2%
Impurity D	≤ 0.10%
Impurity E	≤ 0.10%
Impurity F	≤ 0.10%
Individual unknown impurity	≤ 0.10%
Total impurities	≤ 0.2%
Loss on drying	≤ 0.5%
Sulphated ash	≤ 0.1%
Heavy metals	≤ 20ppm
Bacterial endotoxings (for injection)	≤ 0.56EU/mg
Microbial limits (for injection)
Bacteria	not more than 50CFU/g
Mildew and microzyme	not more than 50CFU/g
Escherichia coli	absence
Residual solvents
Ethanol	≤ 2000ppm
Chloroform	≤ 30pm
Acetic acid	≤ 4000ppm
DMF	≤ 750ppm
Assay (on dried substance)	99.0~101.0%

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
Melting point	198~202℃
Appearance of solution	The solution is clear and is not intenser than reference solution BY7
Impurity C	≤ 1.0%
Related substances
Known impurities
Impurity A	≤ 0.10%
Impurity B	≤ 0.2%
Impurity D	≤ 0.10%
Impurity E	≤ 0.10%
Impurity F	≤ 0.10%
Individual unknown impurity	≤ 0.10%
Total impurities	≤ 0.2%
Loss on drying	≤ 0.5%
Sulphated ash	≤ 0.1%
Heavy metals	≤ 20ppm
Bacterial endotoxings (for injection)	≤ 0.56EU/mg
Microbial limits (for injection)
Bacteria	not more than 50CFU/g
Mildew and microzyme	not more than 50CFU/g
Escherichia coli	absence
Residual solvents
Ethanol	≤ 2000ppm
Chloroform	≤ 30pm
Acetic acid	≤ 4000ppm
DMF	≤ 750ppm
Assay (on dried substance)	99.0~101.0%

Molecular Formula: C15H14FN3O3
Molecular Weight: 303,29

Appearance white to off-white crystalline powder Off-white crystalline powder
Identification
A:IR Spetrum
B:HPLC
A. Sample IR spectrum corresponds with that
of the standard
Conforms
B. The RT of the major peak of the test
solution correcponds to that the standard
solution
Conforms
Residue on ignition ≤0.1% 0.04%
Loss on drying ≤0.5% 0.06% Heavy metals ≤0.002% ＜0.002%
Related compounds
( TLC)
N,N-Dimethylformamide diethyl acetal
(impurity C): ≤0.2%
＜0.2%

Appearance white to off-white crystalline powder Off-white crystalline powder
Identification
A:IR Spetrum
B:HPLC
A. Sample IR spectrum corresponds with that
of the standard
Conforms
B. The RT of the major peak of the test
solution correcponds to that the standard
solution
Conforms
Residue on ignition ≤0.1% 0.04%
Loss on drying ≤0.5% 0.06% Heavy metals ≤0.002% ＜0.002%
Related compounds
( TLC)
N,N-Dimethylformamide diethyl acetal
(impurity C): ≤0.2%
＜0.2%

Appearance white to off-white crystalline powder Off-white crystalline powder
Identification
A:IR Spetrum
B:HPLC
A. Sample IR spectrum corresponds with that
of the standard
Conforms
B. The RT of the major peak of the test
solution correcponds to that the standard
solution
Conforms
Residue on ignition ≤0.1% 0.04%
Loss on drying ≤0.5% 0.06% Heavy metals ≤0.002% ＜0.002%
Related compounds
( TLC)
N,N-Dimethylformamide diethyl acetal
(impurity C): ≤0.2%
＜0.2%