Table 5.
Determination of CPS and its related substances in injection formulation
Sample |
Known related substances (%)
|
Unknown
Impurity (%) |
Total Impurities (% ) | Assay (% ) | ||
---|---|---|---|---|---|---|
Imp-1 | Imp-2 | Imp-3 | ||||
Brand I | 0.05 | 0.01 | 0.10 | ND | 0.14 | 101.44 |
Brand II | 0.05 | 0.02 | 0.03 | ND | 0.09 | 103.28 |
Brand III | 0.03 | 0.01 | 0.07 | ND | 0.10 | 102.38 |
ND: not detected.