Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs. Vielle (EDQM): The new chapter ‘Test for bacterial endotoxins using recombinant factor C’ (2.6.32) describes a ...
As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges. Pharmacopeias have historically provided collections of medical recipes intended to ensure accurate ...
“EDQM may, therefore, block applications at receipt from May 2024 in case these are considered deficient to start the assessment process.” The directorate published the updated guideline days before ...
EDQM analyzed a random sample of 30 deficiency letters sent after carrying out initial evaluations of new CEP applications. The top deficiency was a lack of details or poor description of the ...
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