Samples
Purity of samples
Charge Heterogeneity of
Bioacitivity Of samples
Raman spectroscopy
Criteria
HWM%≤3.0,Main Peak%≥97.0
Acid Peak%≤42.0, Main Peak%≥45.0, Basic Peak%≤ 18.0
75–125%
pass
Positive control Within the standard range Within the standard range Within the standard range pass
12-h light treatment Within the standard range Within the standard range Within the standard range pass
24-h light treatment Within the standard range Within the standard range Within the standard range pass
48-h light treatment Within the standard range Within the standard range Within the standard range pass
96-h light treatment Outside the standard range Within the standard range Outside the standard range Fail
12-h heat treatment Outside the standard range Within the standard range Within the standard range Fail
24-h heat treatment Outside the standard range Within the standard range Outside the standard range Fail
48-h heat treatment Outside the standard range Within the standard range Outside the standard range Fail
96-h heat treatment Outside the standard range Outside the standard range Outside the standard range Fail