Amiodarone hydrochloride

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