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.

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.