General monograph Substances for pharmaceutical use".General chapter 5.1.10 is expanded with further considerations regarding the setting up of limits.In order for the policy to be applied, the following changes are proposed to existing Ph. Existing limits remain in individual monographs to maintain the use of well-established limits. "BET specifications are kept in individual monographs for substances for pharmaceutical use. Amongst others they announced for existing monographs: Commission at its 149th Session in June 2014. In September, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published in Pharmeuropa online the information about their new policy for bacterial Endotoxins, which was approved by the Ph.
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