A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation
Table 3
Forced degradation data of neostigmine methylsulfate API.
Condition
Impurity A (% )
Total unknown impurities (% )
Total impurities (% )
Acid hydrolysis (1 mL of 1 N HCl) 60°C and 30 min
0.03
0.14
0.17
Alkali hydrolysis (1 mL of 1 N NaOH) 60°C and 30 min
6.03
0.10
6.13
Alkali hydrolysis (1 mL of 0.1 N NaOH) benchtop
0.20
0.01
0.21
Oxidative hydrolysis (1 mL of 30% H2O2) 60°C and 30 min
0.05
0.26
1.60
Oxidative hydrolysis (2 mL of 30% H2O2) 60°C and 30 min
