Implementation of the Ph. Eur. suitability test for semi-micro determination of water

Author:

Atanasovska Biljana1,Acevska Jelena1,Nakov Natalija1

Affiliation:

1. Faculty of Pharmacy, University “Ss Cyril and Methodius”, Mother Theresa 47, 1000 Skopje, Republic of N. Macedonia

Publisher

Macedonian Pharmaceutical Association

Subject

General Medicine

Reference9 articles.

1. Connors, K.A., 1988. The Karl Fischer Titration of water. Drug Dev. Ind. Pharm. 14, 1891-1903. https://doi.org/10.3109/03639048809151996

2. European Pharmacopoeia (Ph. Eur.) 10th Edition. 2019. EDQM Council of Europe, Strasbourg, France

3. General European OMCL Network (GEON), Quality Management Document, PA/PH/OMCL (07) 108 R11. 2022. Qualification of equipment Annex 5: Qualification of automatic titrators.

4. ICH Q6A: Specifications: Test procedures and acceptance criteria for new drug substances and new drug products; chemical substances. 2000

5. Larsson, W., 2008. New Approaches to Moisture Determination in Complex Matrices based on the Karl Fischer Reaction in Methanolic and Non-Alcoholic Media. VMC, KBC, Umeå University, Umeå. ISBN: 978-91-7264-687-2.

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