| ≥1 piece |
|
Appearance |
White powder |
|
Assay |
98.0 ~ 102.0% |
|
Specific Rotation [a] n 20 |
+14.5º ~ +16.5º |
|
Transmittance |
≥95% |
|
Loss on drying |
≤4.5% |
|
Residue on ignition |
≤0.2% |
|
pH |
4.5~6.0 |
|
Heavy metals |
≤10PPM |
|
Arsenic |
≤3PPM |
|
Lead |
≤1PPM |
|
Organic volatile Impurities |
In conformity with FCCIV/USP24 |
|
Other related substances |
≤2.0% |
|
5-benzyl-3.6-dioxo-2-piperazineacetic acid |
≤1.5% |
|
L-a-aspartyl L-phenylalanine |
0.25% max |
|
L-phenylalanine |
0.5% max |
|
Total acrobic count |
≤100CFU/g |
|
Moulds and Yeasts |
≤100CFU/g |
|
E.Coli |
Negative |
|
Salmonella S.D. |
Negative |