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Neue Ausgabe von Pharmeuropa

(ga). Die 176 Seiten starke Ausgabe von "Pharmeuropa®", Vol. 16.4, Oktober 2004, dem Informationsmedium der Europäischen Arzneibuch-Kommission, enthält 49 europäische Monographie-Entwürfe, die bis zum 31. Dezember 2004 zur Diskussion gestellt werden.

Es sind dies u. a. fünf Monographien über Drogen

  • Artichoke leaf
  • Cynarae scolymi folium)
  • Centaury (Centaurii herba)
  • Purple coneflower herb (Echinaceae purpureae herba)
  • Purple coneflower root (Echinaceae purpureae radix)
  • Rhubarb (Rhei radix)

und zwei Allgemeine Monographien über: 2.8.18 Herbal drugs: Determination of Aflatoxins und 2.8.20 Herbal drugs: Sampling and Sample Preparation.

Von Interessse sind die Kommentare, die zu einigen überarbeiteten Monographien des Nachtrags 5.1 der 5. Ausgabe des Europäischen Arzneibuchs enthalten sind. Die 5. Ausgabe tritt am 1. Januar 2005 in Kraft. Hingewiesen sei auch auf die 4 Bestimmungsmethoden 2.7.4 Assay of Human Coagulation Factor VIII 2.7.11 Assay of Human Coagulation Factor IX 2.7.21 Assay of Human von Willebrand Factor 2.7.22 Assay of Human Coagulation Factor XI.

Interessant ist auch der Vergleich der im Europäischen Arzneibuch in der Homöopathie verwendeten offiziellen lateinischen Namen der Monographien mit den englischen resp. französischen und sonstigen in nationalen Arzneibüchern verwendete Namen, also z. B. Englischer Name: Acetic acid, glacial Lateinischer Name: Acidum aceticum glaciale sonstige national verwendete Namen: Acidum aceticum (D, CH, UK, A), S Aceticum acidum (N, NL) Zur Information sind die Inhaltsverzeichnisse von Pharmacopoeial Forum (USP) Vol. 30, No. 4 (Jul – Aug 2004) und Japanese Pharmacopoeial Forum Vol. 13, No. 2 (May 2004) abgedruckt.

Das Inhaltsverzeichnis von "Pharmeuropa®" Vol. 16.4, Oktober 2004 ist nachstehend abgedruckt. Stellungnahmen sollten bis 31. Dezember 2004 an das Bundesinstitut für Arzneimittel und Medizinprodukte, Geschäftsstelle der Arzneibuch-Kommissionen, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, mit Kopie an das European Directorate for the Quality of Medicines, B.P. 907, F-67029 Strasbourg Cedex 1 (France), Tel. (3 33) 88 41 20 26, Fax (3 33) 88 41 27 71, E-Mail: info@pheur.org gerichtet werden.

Bearbeitet und mitgeteilt von Dr. Gert Auterhoff, Stellvertr. Geschäftsführer Medizin und Pharmazie, Geschäftsfeld Pharmazie, Bundesverband der Pharmazeutischen Industrie e. V. (BPI), Karlstr. 21, 60329 Frankfurt/Main (Germany)

Inhaltsverzeichnis von Pharmeuropa 16.4, Oktober 2004 Publication of Supplements 5.1 and 5.2 General Information

Electronic version of the 5th Edition of the European Pharmacopoeia CRS: conditions of sale List of CRS adopted at the June 2004 session List of texts adopted at the June 2004 session Lists of texts published in Supplement 5.1 Comments concerning some revised/ corrected texts published in Supplement 5.1 Titles used in homoeopathy Updated work programme of the European Pharmacopoeia (June 2004) Pharmeuropa Bio Proceedings of conferences List of Standard Terms: updated 2004 40th Anniversary of the European Pharmacopoeia The first Editions of the European Pharmacopoeia (1964 – 1996)

Press releases

  • Meeting of the Pharmacopoeial Discussion Group (Rockville, 7 – 11 June 2004)
  • Lithuania becomes the 33rd member of the European Pharmacopoeia
  • 9th Annual meeting of the European network of official medicines control laboratories (OMCL)(Langen, Germany, 10 – 14 May 2004)

International Conferences Chemicals

2 – 3 December 2004, Strasbourg, France 17 February 2005, London, United Kingdom 20 – 21 April 2005, New Jersey, United States 1 – 2 December 2005, Strasbourg, France

Homoeopathy

11 February 2005, Strasbourg, France

European Pharmacopoeia 5th Edition: key role for quality the regulatory system

Symposium included in the Pharmaceutical Sciences Fair 16 June 2005 (morning session), Nice, France

Certification

27 – 28 October 2005

Certification of Suitability of the Monographs of the Ph. Eur.

New procedure for management of revisions/renewals of certificates of suitability to the European Pharmacopoeia monographs Guideline on requirements for revision/renewal of certivicates Certificates of suitability: implementation of the 5th Edition of the European Pharmacopoeia List of certificates

Enquiry

Glycerol monostearate 40 – 55

Scientific Notes

Agarose as an Alternative Supporting Medium for Protein Composition Determination in Therapeutic Immunoglobulins (corrigendum of the article published in Pharmeuropa 16.3)

Draft Monographs for Comment

PLEASE NOTE THAT THE DURATION OF ENQUIRY IS NOW 3 MONTHS β-Acetyldigoxin Activated coagulation factors (2.6.22) Adenovirus vectors for human use Adrenaline tartrate Alternative methods for control of microbiological quality (5.1.6) Artichoke leaf Assay of human coagulation factor VIII (2.7.4) Assay of human coagulation factor IX (2.7.11) Assay of human coagulation factor XI (2.7.22) Assay of human von Willebrand factor (2.7.21) Bacterial cells used for the manufacture of plasmid vectors for human use (5.2.10) Centaury Digoxin Dopexamine dihydrochloride Enalaprilat dihydrate Etidronate disodium Febantel for veterinary use Feline chlamydiosis vaccine (inactiva-ted) Flow cytometry (2.7.24) Fumitory Gene transfer medicinal products for human use Guaiacol Herbal drugs: determination of aflatoxins (2.8.18) Herbal drugs: sampling and sample preparation (2.8.20) Human haematopoietic progenitor cells Lansoprazole Marek's disease vaccine (live) Microbiological control of cell therapy products (2.6.27) Mycoplasma gallisepticum vaccine (inactivated) Newcastle disease vaccine (inactivated) Noradrenaline hydrochloride Noradrenaline tartrate Nucleic acid amplification techniques (2.6.21) Numeration off CD34+ cells in haematopoietic products (2.7.23) Oxazepam Plamid vectors for human use Poxvirus vectors for human use Prekallikrein activator (2.6.15) Purple coneflower herb Purple coneflower root Pyrrolidone Reagents used in the production of cell and gene therapy products (5.13) Rhubarb Sodium tetrachloroaurate dihydrate for homoeopathic preparations Terazosin hydrochloride dihydrate Thioctic acid Triamterene Venlafaxine hydrochloride Vigabatrin

International Harmonisation

Particle size analysis by light diffraction (2.9.31) Characterisation of crystalline and partially crystalline solids by X-ray powder diffraction (XRPD) (2.9.33) PDG state of work (July 2004) Projected timeable for publication and implementation of texts signed off by the PDG (August 2004) Contents of the USP Forum (Vol. 30, No. 4) Contents of the JP Forum (Vol. 13, No. 2)

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