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

Table 11

Accelerated stability study of NMS injection studied for 6 months at various temperature and humidity conditions and temperature cycling study.

	40°C/75% RH for 6 months (upright)	40°C/75% RH for 6 months (inverted)	2–8°C for 6 months (upright)	2–8°C for 6 months (inverted)	Temperature cycling study
(%) of Impurity A	0.07	0.07	0.02	0.02	0.07
(%) of unknown impurities	0.04	0.05	0.05	0.05	0.14
(%) of total impurities	0.11	0.12	0.07	0.07	0.21