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