Impurities Testing
Found 4 free book(s)
ICH Topic Q 3 A Impurities Testing Guideline: Impurities ...
www.pharma.gally.chImpurities Testing Guideline: Impurities in New Drug Substances Step 5 NOTE FOR GUIDANCE ON IMPURITIES TESTING: IMPURITIES IN NEW DRUG SUBSTANCES (CPMP/ICH/142/95) APPROVAL BY CPMP May 1995 DATE FOR COMING INTO OPERATION (STUDIES COMMENCING AFTER) 1 November 1995. CPMP/ICH/142/95 1/11
Nitrosamines EMEA-H-A5(3)-1490 - Information on ...
www.ema.europa.euimpurities if amines (see examples above) are present in any step of the synthesis. ... Step 2 confirmatory testing: in the event that a risk of presence of nitrosamines is identified as a result of the risk evaluation, confirmatory testing should be carried out using appropriately
Guideline on Inhalational medicinal products
www.ema.europa.euimpurities, process validation, stability testing, specifications) as well as safety and efficacy aspects, are described in other guidance documents, including ICH guidelines. Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the analytical procedures used primarily for inhalation and nasal products (e.g ...
Annex 9 Guide to good storage practices for pharmaceuticals
www.who.int• The stability testing of pharmaceutical products containing ... The undesired introduction of impurities of a chemical or microbio-logical nature, or of foreign matter, into or onto a starting m aterial, or intermediate or finished product during production, sampling, pack-