|
Item |
USP24 |
USP38 |
AJI92 |
EP8 |
|
Assay |
98.5-101.5% |
98.5-101.5% |
98.5~101.0% |
98.5-101.0% |
|
PH |
5.5-7.0 |
5.5-7.0 |
5.5-6.5 |
--- |
|
Specific rotation[a]D20 |
--- |
--- |
+39.5~+41.5° |
+40.0-+43.0 |
|
Specific rotation[a]D25 |
+38.9°-+41.8° |
+38.9°-+41.8° |
--- |
--- |
|
Transmittance(T430) |
--- |
--- |
≥98.0% |
clear & colorless ≤BY6 |
|
Chloride(Cl) |
≤0.05% |
≤0.05% |
≤0.02% |
≤0.02% |
|
Ammonium(NH4) |
--- |
--- |
≤0.02% |
--- |
|
Sulfate(SO4) |
≤0.03% |
≤0.03% |
≤0.02% |
≤0.03% |
|
Iron(Fe) |
≤30PPM |
≤30PPM |
≤10PPM |
≤10PPM |
|
Heavy metals(Pb) |
≤15PPM |
≤15PPM |
≤10PPM |
≤10PPM |
|
Arsenic |
≤1.5PPM |
--- |
≤1PPM |
--- |
|
Other amino acids |
--- |
individual impurities≤0.5% total impurities≤2.0% |
≤0.5% |
--- |
|
Ninhydrin-positive substances |
--- |
--- |
--- |
conform |
|
Loss on drying |
≤0.30% |
≤0.30% |
≤0.20% |
≤0.5% |
|
Residue on ignition |
≤0.30% |
≤0.30% |
≤0.10% |
≤0.10% |
|
Organic volatile impurities |
conforms |
--- |
--- |
--- |