Items
|
Standard
|
Result
|
Appearance
|
White to almost white powder
|
White powder
|
Individual impurity
|
≤0.10%
|
0.03%
|
Assay, on dry base
|
98.5%~101.0%
|
99.2%
|
Chromatographic Purity by HPLC
|
≥99.5%
|
99.8%
|
Enantiomers
|
≤0.1%
|
ND
|
Melting point
|
71C~84
ºC
|
76.5
ºC~80.5ºC
|
Specific rotation (20/D)
|
-5.8
°~-6.8°(C=1, AcOH)
|
-6.0
°
|
Solubility
|
Soluble in AcOEt (1g in 10ml)
|
Clear
|
Lost on Drying
|
≤0.5%
|
0.23%
|
Boc-glycine
|
≤0.02
|
ND
|
Boc-alanine
|
≤0.02
|
0.02%
|
Boc-isoleucina
|
≤0.08%
|
0.02%
|
Boc-leucina
|
≤0.05%
|
ND
|
Conclusion
|
Conform to high purity grade standard
|
Package
|
25kg/barrel
|
Storage conditions
|
Store in a well-closed container, protected from light, at room temperature
|