| ≥1 piece |
Tests and Results
Test Requirement Result
Assay 98.0% ~ 102.0% 99.06%
Specific rotation +14.5??~ + 16.5?? +14.67??
Transmittance ?Y95.0 % 99.07%
Loss on drying ?ü 4.5% 2.24%
Residue on ignition ?ü 0.2% 0.09%
Diketopiperazine ?ü 1.5% 0.17%
L-|á-aspartyl-L-phenylalanine ?ü 0.25% 0.17%
Organic volatile impurities Conform to USP Conform
Other related substances ?ü 2.0% 0. 01%
Appearance of solution Conform to EP Conform
Heavy metals (as Pb) ?ü 10ppm < 5ppm
Lead ?ü 1ppm < 1ppm
Arsenic ?ü 3ppm < 2ppm
PH 4.5 ~ 6.0 5.18
Statement The product meets the requirements of USP27