Items

Standard

Result

Appearance

White or slightly yellowish crystalline powder

White crystalline

powder

Related substances

Impurity A

≤0.15%

0.05%

Impurity B

≤0.15%

0.02%

Impurity C

≤0.2%

0.03%

Impurity D

≤0.2%

0.05%

Unspecified

impurity

≤0.1%

0.06%

Total impurities

≤1.0%

0.3%

Residual solvents

Methanol

≤0.3%

Undetected

Ehtanol

≤0.5%

0.03%

Methylene dichloride

≤0.06%

Undetected

N-hexane

≤0.03%

Undetected

Acetic acid

ethyl ester

≤0.5%

Undetected

Toluene

≤0.09%

0.025%

Acetic acid

≤0.5%

0.036%