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CAS NO.19774-82-4
APIs
Product name: Amiodarone Hcl
CAS NO: 19774-82-4
EINECS No.: 243-293-2
MW: 681.77
Appearance: white crystalline powder
Melting Range: 159~163°C
Purity:99%
Specification
Items |
Specifications |
Results |
Characters |
|
|
Appearance |
White or almost white, fine crystalline powder |
conforms |
Solubility |
Very slightly soluble in water, freely soluble in methylene chloride, soluble methanol, sparingly soluble in ethanol(96%) |
conforms |
Identification |
|
|
A) IR |
Conforms to Amiodarone HCL CRS |
Conforms |
B) Chlorides |
It gives reactions of chlorides |
Conforms |
Appearance of solution |
clear, NMT GY5 |
Conforms |
Melting Range |
159~163°C |
159.0~160.0°C |
pH |
3.2~3.8 |
3.63 |
Impurity H (by TLC) |
NMT 0.02% |
<0.02% |
Related Substance (by HPLC |
|
|
Impurity A |
NMT 0.20% |
0.07% |
Impurity B |
NMT 0.20% |
0.10% |
Impurity C |
NMT 0.20% |
conforms |
Impurity D |
NMT 0.20% |
0.05% |
Impurity E |
NMT 0.20% |
0.03% |
Impurity F |
NMT 0.20% |
conforms |
Impurity G |
NMT 0.20% |
0.01% |
Unspecified impurities |
NMT 0.20% |
0.02% |
Total impurities |
NMT 0.20% |
0.34% |
Iodides |
NMT 150ppm |
<150ppm |
Heavy metals |
NMT 20ppm |
<20ppm |
Loss on drying |
NMT 0.5% |
0.08% |
Sulphated ash |
NMT 0.1% |
0.02% |
Assay |
98.5%~101.0% |
100.00% |
Residual Solvents |
|
|
Ethanol |
NMT5000ppm |
782ppm |
Toluene |
NMT890ppm |
94ppm |
Conclusion |
The results can conforms with the EP6 |
Usage
1) Amiodarone Hcl is an anti-arrhythmic agent used for various types of cardiac dysrhythmias, both ventrucular and artrial.
2) It is also used in arrhythmias that are otherwise difficult to treat with medication.