A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation

Table 9

Accelerated stability study data of NMS API.

Conditions	Neostigmine methylsulfate API
	Impurity A (% )	Total impurities (% )
40°C/75% RH, 1 M	0.06	0.21
25°C/60% RH, 3 M	0.06	0.23
40°C/75% RH, 3 M	0.06	0.25
25°C/60% RH, 6 M	0.05	0.10
40°C/75% RH, 6 M	0.05	0.10