Appearance

White or off-white powder

Identification By HPLC

Retention time is same with the reference substance

Amino Acid Analysis

Asp  0.7~1.1

Gly  0.8~1.1

Thr  0.9~1.2

Pro  0.9~1.4

Tyr  0.8~1.2

Ile  0.8~1.2

Cys  present

pH

4.0~6.0

Specific Optical Rotation

-45~-55 º (c=1%，HAc)

Purity (HPLC) :

NLT 98.5 %

Related Substances(HPLC)

Impurity A NMT 0.4%

Impurity B NMT 0.5%

Impurity C NMT 0.5%

Any unidentified impurities not more than 0.1%

Acetic acid (HPLC)

5.0%~12%

Water Content(Karl Fischer) :

≦8.0%

Residue Solvents:

Acetonitrile (ACN)

Dichloromethane (DCM)

N,N-DimethylFormamide(DMF)

Diisopropylether(DIPE)

Trifluoroacetic acid(TFA)

Ethanol

≤0.041%(w/w)

≤0.06%(w/w)

≤0.088%(w/w)

≤0.5%(w/w)

≤0.5%(w/w)

≤0.5%(w/w)

Bacterial endotoxins

NMT 12.2EU/mg

Assay (By Anhydrous,Acetic Acid-free)

96.0%~104.0%