A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation
Table 4
Forced degradation data of neostigmine methylsulfate injection.
Condition
Impurity A (% )
Total unknown impurities (% )
Total impurities (% )
Acid hydrolysis (2 mL of 1 N HCl) 60°C and 30 min
0.86
0.03
0.89
Alkali hydrolysis (5 mL of 0.1 N NaOH) benchtop
9.98
0.02
10.00
Alkali hydrolysis (5 mL of 0.1 N NaOH) 60°C and 30 min
