What is the timing of the new standard?
A. USP’s standards–revision process involves international collaboration among USP experts, industry, regulators, and the general public. When there is no specific medical emergency, as is the case with elemental impurities, it is beneficial to allow careful deliberation and scientific dialog to reach conclusions that are supported by a maximum number of interested stakeholders. In addition, where the new standards represent a significant change from existing standards, as is also the case with elemental impurities, it is important to provide sufficient time for manufacturers to incorporate the changes in their processes necessary to implement the new standards.
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