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

Table 10

Accelerated stability study of NMS injection studied from 1–6 months at various temperature and humidity conditions.

	25°C/60% RH (1 month)	40°C/75% RH (1 month)	25°C/60% RH (3 months)	40°C/75% RH (3 months)	2–8°C (3 months)	25°C/60% RH (6 months) (upright)	25°C/60% RH (6 months) (inverted)
(%) of Impurity A	0.02	0.04	0.02	0.04	0.02	0.03	0.03
(%) of unknown impurities	0.02	0.05	0.07	0.07	0.07	0.04	0.05
(%) of total impurities	0.04	0.09	0.09	0.11	0.09	0.07	0.08