Items of analysis
Specification
Resulst
Appearance
White granular
White powder
Assay
98%-102%
99.85%
Taste
Pure
Specific rotation
+14.5°-16.5°
+15.91°
Transmittance
95.0% min
99.0%
Loss on drying
4.5% max
2.94%
Residue on ignition
0.20% min
0.04%
L-a-Aspartyl-L-Phenylalanine
0.25% min
＜0.25%
pH
4.50-6.00
4.93
Organic Volatile Impurities
Conform to usp
conform
L-Phenylalanine
0.50% max
＜0.50%
Heavy metals(as Pb)
10ppm max
＜10ppm
Arsenic (AsP)
3ppm max
＜3ppm
5-benzyl-3,6-dioxo-2-piperazineacetic acid
1.5% max
＜1.5%
Other related substances
2.0% max
＜2.0%
Conclusion: compliance with FCCIV EP3