English to Russian Medical Medical: Pharmaceuticals

Table 1 Validation Results Summary for Determination of Related Substances (continued)
Parameter
Study Description
Results
Linearity
Drug substance:
Single preparation of 10 concentrations from 0.05% to 120% of the sample solution
BAL17701, BAL8728, BAL19712, BAL4815, BAL31265 and BAL30145:
Single preparation of 5 concentrations from 0.05% to 5% of the sample solution
BAL19875, BAL17704, BAL20019, BAL19717, BAL31264, BAL20027 and BAL30655:
Single preparation of 5 concentrations from 0.04% to 4% of the sample solution