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Suppliers for
Flumazenil
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Properties | CAS |
78755-81-4 | Formula |
C15H14FN3O3 |
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14 Registered suppliers
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
More details are to be found here
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%
More details are to be found here
More details are to be found here
More details are to be found here
More details are to be found here
More details are to be found here
More details are to be found here
More details are to be found here
Detailed information on the suppliers of
Flumazenil
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Properties:
... more properties and specification on Flumazenil
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Last update 2024-04-29
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