Pharmacopoeia.Where a substance for pharmaceutical use not described inan individual monograph of the Pharmacopoeia is used in amedicinal product prepared for the special needs of individualpatients, the need for compliance with the present generalmonograph is decided in the light of a risk assessment...
内容提示: EUROPEAN PHARMACOPOEIA 7.05.11. Characters section in monographs01/2008:511005.11. CHARACTERS SECTION INMONOGRAPHSThe General Notices indicate that the statements included inthe Characters section are not to be interpreted in a strictsense and are not requirements. For information of users, ...
before use of the product, whereapplicable.01/2008:1468PRODUCTS OF FERMENTATIONProducta ab fermentationeThis monograph applies to indirect gene products obtained byfermentation. It is not applicable to:— monographs in the Pharmacopoeia concerning vaccinesfor human or veterinary use;— products derived ...
EUROPEAN PHARMACOPOEIA 7.0Insulin preparations, injectabletest fails, adjust the injection volume to between 10 μL and20 μL, in order that the responses are within the linearityrange of the detector.Injection: 20 μL of the test solution.Calculate the content of porcine insulin C256H381N65O76...
pharmacopoeiaeuropeanmonographsmonographcontainersheading EUROPEAN PHARMACOPOEIA 8.0 1. General notices the preamble to the specification. The use of materials with different formulations, and the test methods and limits applied to them, are subject to agreement by the competent authority. The specifi...
The European Pharmacopoeia monographs for heparin preparations have been revised, reports the MHRA. In response to the recent increase in reports of adverse events associated with heparin preparations, in the US and parts of Europe,* the level of quality control testing has been strengthened in ...
European pharmacopoeia, volume II. Published under the direction of the Council of Europe (Partial Agreement) in accordance with the Convention on the Elaboration of a European Pharmacopoeia. Maisonneuve S. A., 57-Sainte-Ruffine, France, 1971. (U. S. distributor: Rittenhouse, 1706 Rittenhouse Sq...
Control of Impurities in the European Pharmacopoeia – Principles and update on new developments Dr. Michael Wierer Deputy Head, European Pharmacopoeia Department, EDQM, Council of Europe Contents 1. Principles of Ph.Eur. impurity control 2. Potentially genotoxic impurities in monographs 3. New ...
http://www.gmp-compliance.org/enews_05296_ICH-Q3D-implemented-in-the-European-Pharmacopoeia-Revision-of-Two-General-Monographs-with-Regard-to-Elemental-Impurities_15499,15332,S-AYL_n.html In apress release dated 30 November 2015, the EDQM announced the revision of two general pharmacopoeial monogra...
4479 General Notices (1) apply to all monographs and other texts 4441 EUROPEAN PHARMACOPOEIA 11.0 Index 1. General notices... 3 2.1. Apparatus ... 17 2.1.1. Droppers ...