Item |
Specification |
Appearance |
Off-white or white powder |
Identification |
Chromogenic reaction: positive reaction |
|
HPLC: Under the content determination of record chromatograph chart, the main peak of retention time of test sample solution should be consistent with that of the reference substance solution. |
|
IR: Infrared absorption spectrum of the product shall be consistent with the reference substance of the map. |
Specific rotation |
Between+9.5oand +11.0o |
Clarity and color |
Solution should be clarified, such as turbidity, compared with 1 turbidity standard solution may not be thicker.
Solution should be colorless, such as color, compared with standard colorimetric liquid yellow 1, shall not be deeper.
|
Heavy metals |
Not more than 10ppm |
pH |
5.0~6.0 |
Loss on dry |
Not more than 0.5% |
Residue on ignition |
Not more than 0.1% |
Ferric salt |
Not more than 0.001% |
Sulfate |
Not more than 0.02% |
Chloride |
Not more than 0.02% |
Ammonium salt |
Not more than 0.02% |
Related substance
|
Cyclo-L-Alanyl-L-Glutamine≤0.2% |
|
Cyclo-L-Alanyl-L-Glutamyl≤0.04% |
|
L-Pyroglutamyl-L-Alanine≤0.15% |
|
L-Pyroglutamic acid≤0.05% |
|
D-Alanyl-L-Glutamine≤0.05% |
|
L-Alanyl-L-Glutamate≤0.5% |
|
Any unspecified impurity≤0.1% |
|
Any unspecified total impurities≤0.5% |
Bacterial endotoxin |
Not more than 0.050EU/mg |
Assay(on dried basis) |
Not less than 99.0% |