European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products'

Pharmaeuropa text open for comments.

Inclusion of sartan-containing medicinal products in the scope of procedures A and C, and procedure A can be applied as a quantitative test. Addition of the requirement for performing a validation when a procedure is modified beyond the allowable adjustments of chromatographic conditions listed in Chromatographic separation techniques (2.2.46).

2.5.42. N-Nitrosamines in active substances and medicinal products
Reference number: PA/PH/SG (20) 68 ANP
Text number: 20542
Direct link to proposal MG 36.1 2024-03-31