Items Standard Analysis data
Appearance White to off-white powder Conforms
Melting point(ºC) 135-145ºC 138°C
Optical Rotation[α]D20
(1%,MeOH) -34.5±1.0 -33.5
TLC semi- Conforms to reference,≤0.25%pGlu-OH Conforms
Purity (HPLC) ≥98.0% 99.0%
Assay(NaOH) 98.0-102.0% 99.0%
Water content(KF) ≤1.0% 0.48%
Enantiomeric purity ≤0.5% D-Enantiomer conforms