Background & Aim: Hydroxycinnamic acids are one of the most important bioactive substances of Echinacea drugs. These compounds possess immuno-enhancing activity and thus, total hydroxycinnamic acids are mostly used as the main criterion for quality control of Echinacea purpurea and its drugs.  Hence, the quality control of Echinacea requires to develo...

Ethics Statement Production of specific pathogen–free eggs (VALO BioMedia GmbH, OsterholzScharmbeck, Germany) was performed in accordance with the guidelines of the European Pharmacopoeia (EP7.0.5.2.2.) and the US Department of Agriculture Veterinary Services (Memorandum 800.65). All procedures regarding embryonated chicken eggs were in accordance with the German Animal Protection Law. For infe...

Medicated chewing gums are defined by the European Pharmacopoeia 1 and the guidelines for pharmaceutical dosage forms as „„solid single dose preparations with a base consisting mainly of gum that are intended to be chewed but not swallowed, providing a slow steady release of the medicine contained‟‟2. It can be either used for local treatment of mouth disease or systemic delivery by direct intr...

The influence of temperature and relative air humidity on the stability of cefaclor monohydrate in crystalline form and in its pharmaceutical preparations (oral suspension and slow release tablets) was investigated. The process of degradation was studied by using high-performance liquid chromatography with ultraviolet (UV) detection, as described in the monograph of cefaclor in European Pharmac...

An international collaborative study has been organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the World Health Organization (WHO) 2nd International Standard (IS) for Vancomycin. Twelve laboratories from 10 different countries participated. The potency of the candidate material, a freeze-dried preparation, was estimated by microbiological assay...

Background Mycoplasma testing on cell lines or biological products used to be performed based on classical methods such as agar and broth medium and/or indicator cell culture. However, these methods require a long incubation period and are not adapted for samples, like live-attenuated vaccine viruses (which can not completely be neutralized) or cell therapy products (with short shelf life). NAT...

The development and validation of suitable alternatives for the replacement of in vivo challenge testing in the evaluation of vaccines is an important goal for national authorities and manufacturers involved in the assessment of quality, safety and efficacy of such products. To that end, 13 laboratories from 9 European countries, including 5 manufacturers, 7 authorities and EDQM3, have taken pa...