2004/24/EC amending 2001/83/EC and 2004/28/EC amending 2001/82/EC 2 see www.pheur.org 3 Council of Europe European Treaty Series No. 50, 22/07/1964 and No. 134. 01/11/1992 4 Council of Europe European Treaty Series No. 123, 18/03/1986 5 Artiges, A. (1999). Alternatives to animals in the development and control of biological products for human and veterinary use. The role of the European Pharmac...

For many years now, a number of Western herbs have been widely used in health food products in Japan and as pharmaceuticals in Europe. There are few or no mandated criteria concerning the quality of these herbal health food products, thus clarification is warranted. Here, we performed disintegration tests of 26 pharmaceutical and health food products containing the Western herbs ginkgo leaf and...

Physicochemical and anticoagulant characteristics of 27 samples from recent batches of commercially produced unfractionated heparin have been determined as part of the process of establishment of the 5th International Standard Unfractionated Heparin. They have been compared with current heparin standards (European Pharmacopoeia, United States Pharmacopoeia, Chinese), with the 4th International ...

The methods for determination of chitosan content recommended in the Chinese Pharmacopoeia and the European Pharmacopoeia are not applicable for evaluation of the extent of deacetylation (deacetylation degree, DD) in chitooligosaccharides (COS). This study explores two different methods for assessment of DD in COS having relatively high and low molecular weights: an acid-base titration with bro...

Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class that is primarily used in the treatment of hypertension. During the scale-up of the lisinopril process, one unknown impurity was observed and is identified. The present work describes the origin, synthesis, characterization, and control of this impurity. This paper also describes the synthesis and characterization o...

Methods In this study, the VHC called Tipshaler (Protec’som, France) was evaluated with fluticasone (Flixotide, 50μg/dose, GSK, France) and beclomethasone (QVAR, 100μg/dose, MEDICIS, Canada). The method according to the European Pharmacopoeia used a constant flow rate (30 L / min) was used. Particle size distribution was measured using a NGI cascade impactor (Copley Scientific, Nottingham, Unit...

In the past few decades, single enantiomers and stereoisomers have overtaken achiral molecules in the percentage of approved drugs in the market. Because isomers can have different biological/pharmacological/toxicological properties, authorities such as the European Pharmacopoeia and the FDA have asserted escalated emphasis on controlling isomer content in drug compounds and require that stereo...

Backgrounds: Thallium-201 is produced through 203Tl (p, 3n) 201pb 201Tl reaction by cyclotron. This radioisotope has known as one of the cyclotron radioisotopes which is used for myocardial perfusion in the coronary artery disease, Tl-201 after chemical purification and quality control in the form of 201Tl-chlorid is ready to send to the hospitals. Materials and methods: In this work the effect...

Pharmacopoeia is an official reference containing a selected drugs/medicinal preparations with their description, tests for their identity, purity and potency and with their average doses. A few famous pharmacopoeia and other reference books are the Indian Pharmacopoeia (IP), the British Pharmacopoeia (BP); the United States Pharmacopoeia (USP); the British Pharmaceutical Codex (BPC); the Natio...