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We validated a new contaminant detection method suitable for analysis of nalmefene
hydrochloride injection. This validation was more thorough than that of prior similar studies
of nalmefene hydrochloride injection, because it included a determination of the correction
factors and durability testing. With two known impurities as controls, this method accurately
determined the content of both known impurities with good reproducibility and stability. In
addition, the method is accurate and feasible for laboratory implementation.
To validate the related substance includes: durability, solution stability and precision.
Durability results show that the method applicability. Solution stability according to the
results; Product into 12 hours as ...