items

standard

result

appearance

white powder

conforms

solubility

soluble in water or 1% acetic acid at a concentration of ≥1mg/ml to give a clear, colorless solution

conforms

identity by hplc

the retention is same with the reference substance

conforms

amino acid composition

gly:0.85～1.10

pro:0.85～1.10

leu:0.85～1.10

cys:1.65～2.20

asn:0.85～1.10

gln:0.85～1.10

ile:0.85～1.10

tyr:0.85～1.10

1.02

1.06

1.01

1.88

0.96

1.01

0.99

1.02

ph

3.0～6.0

5.16

specific optical rotation

c=1,1%hac

-21.2°

purity

≥98.0%

99.12%

related substance(by hplc)

total impurities(%)≤2.0%

largest single impurity(%)≤1.0%

0.88%

0.55%

acetate content(by hplc)

≤12.0%

6.7%

water

≤8%

5.7%

peptide content (n%)

≥80.0%

87.6%

bacterial endotoxins

≤70iu/mg

conforms

residual organic solvents

acetonitrile ≤0.041%(by gc)

dmf ≤0.088%(by gc)

meoh ≤0.3% (by gc)

tfa ≤0.1% (by hplc)

dcm ≤0.06% (by gc)

mecn ≤0.041% (by gc)

conforms

assay

95%～105%

99.3%

conclusion

complies with the standard.