tem

Specification

Results

Characteristic

White or almost white powder

White powder

Identifications

A.HPLC

Retention time conforms to that of the reference standard.

Conforms

B. Amino acids

Asp:0.90-1.10; Glu:0.90-1.10

Pro:0.90-1.10; Gly:0.90-1.10

Leu:0.90-1.10; Tyr:0.7-1.05

Half-Cys:1.4-2.1; Ile:0.90-1.10

Conforms

PH

3.0-6.0

5.0

Related substances(HPLC)

Impurity A≤1.0%

Impurity B≤1.0%

Impurity C≤1.5%

Other single impurity≤0.5%

Total impurities≤5.0%

0.11%

0.34%

0.1%

0.13%

0.8%

Acetic acid(HPLC)

6.0%-10.0%

7.4%

Water(KF)

NMT5.0%

1.2%

Bacterial endotoxins

Less than 300IU/mg

Conforms

AcN(GC)

Not more than 0.041%

Conforms

MeOH(GC)

Not more than 0.3%

Conforms

Triethylamine(GC)

Not more than 0.032%

Conforms