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1996 ].The National Institute for Occupational Protection and Wellbeing (NIOSH) has proposed a method that may be applied to use occupational exposure banding to the broader spectrum of substances used in occupational options. The proposed NIOSH occupational exposure banding procedure makes use of out there, but normally limited, toxicological info
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Approach validation need to verify that the impurity profile for every API is within the restrictions specified. The impurity profile must be comparable to, or a lot better than, historic facts and, where by applicable, the profile established through course of action improvement or for batches utilized for pivotal clinical and toxicological report