ITEMS

SPECIFICATION

RESULTS

Appearance

White or almost white, crystalline powder,

slightly hygroscopic

Conform

Assay

99~101.0%(Ahhydrous substance)

99.8%

Identification

A.Infrared absorption spectrophotometry

B.TLC

Conform

Specific optical rotation

-66^º~ -69^º

-68.21^º

Water

≤1.0%

0.56%

ImpurityA(TLC)

≤0.25%

＜0.25%

Stereochemical purity

(HPLC)

Impurity I≤0.1%

N.D.

Substances (HPLC)

ImpurityB≤0.3%

0.12%

ImpurityE≤0.4%

N.D.

ImpurityF≤0.2%

N.D.

ImpurityH≤0.2%

N.D.

Any other unknown impurity≤0.1%

0.06%

Total impurities≤1.0%

0.33%

Pd

≤5PPM

＜5PPM

Sulphated ash

≤0.1%

＜0.1%

Heavy metal

≤10PPM

＜10PPM

Residual Solvents

Acetone≤5000PPM

Ethanol≤5000PPM

Ethyl acetate≤5000PPM

Methylene chloride≤600PPM

＜5000PPM.

N.D.

N.D.

N.D.

Conclusion: Conforms to the standard of EP3