EDQM: Comments on the Nitrosamine Monograph possible

The updated text of the monograph "2.5.42. N-Nitrosamines in active substances and medicinal products" has been published on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) in the Pharmeuropa section and can be commented on until 31 March 2024, along with several other new drafts.

In addition to formal changes, the new text also contains the addition "and medicinal products" in the title, so that the complete monograph now refers not only to active substances but also to medicinal products containing these active substances. Newly added passages are marked with light green arrows, such as the paragraph under Table 1 "Scope of the validation" and Table "Validation parameters to be covered when a procedure is applied to substances outside the scope of the initial validation, or when a procedure has been considerably modified". The dark green arrows again frame deletions of passages and text deletions.

You can view and comment on the updated text of the monograph "2.5.42. N-Nitrosamines in active substances and medicinal products" on the Pharmeuropa website after registering once.

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