Europäisches Arzneibuch: Neue Ausgabe von Pharmeuropa

Im Rahmen der "Rapid Implementation" wird in allen 20 Aminosäurenmonographien des Europäischen Arzneibuchs im Kapitel "Production" auf die Monographie "Products of fermentation" verwiesen. Die Liste der geänderten 20 Monographien ist dem Inhaltsverzeichnis zu entnehmen. Diese Änderungen traten am 1. Januar 1999 in Kraft.

Weiterhin ist eine aktuelle Auflistung (Stand: Oktober 1998, 12 Seiten) der Substanzen, die über ein Zertifikat nach dem Zertifikatsystem des Europäischen Arzneibuchs verfügen, enthalten. Außerdem werden im Rahmen der internationalen Harmonisierung zur Information die Inhaltsverzeichnisse des Japanese Pharmacopoeial Forum Vol. 7, No. 4/October 1998 sowie das Pharmacopoeial Forum (USP) Vol. 24, No. 5/Sept.-Oct. 1998 sowie Vol. 24, No. 6/Nov.-Dec. 1998 publiziert.

Das Inhaltsverzeichnis von "Pharmeuropa" Vol. 10.4, December 1998, ist nachstehend abgedruckt. Stellungnahmen sollten bis 31. März 1999 an das Bundesinstitut für Arzneimittel und Medizinprodukte, Geschäftsstelle der ArzneibuchKommission, Seestraße 10,D-13353 Berlin, mit Kopie an das Technical Secretariat of the European Pharmacopoeia Commission, B.P. 907, F-67029 Strasbourg Cedex 1 (France), Tel. (00333) 88412036, Telex 880388f, Fax (00333) 88412771 gerichtet werden.

Bearbeitet und mitgeteilt von Dr.Gert Auterhoff, Bundesverband der Pharmazeutischen Industrie e.V., Abteilung Pharmazie, Karlstraße 21, D-60329 Frankfurt a.M.

Inhalt von Pharmeuropa 10. 4.

General Information CD-ROM 1999 Conditions of sale of CRS Prepublication brochure - order form Press releases: -European co-ordination of the monitoring of the quality of medicinal products authorised by the community -Annual meeting of the European network of official medicines control laboratory (OMCL) -Seville conference: a decisive step in the international harmonisation process

Scientific Notes The development of a liquid chromatographic method to limit related substances in Mefenamic acid and a survey of the purity of samples of diverse origin Liquid chromatographic method for the assay of Benzathine benzylpenicillin and the determination of impurities

International Conference Biologicals beyond 2000: challenges for quality standards in an evolving field Strasbourg, France, 27-28 September 1999 & Satellite symposium on veterinary biologicals Strasbourg, 29. September 1999

Readers' Tribune Capillary electrophoresis in the pharmaceutical industry

Certification of Conformity of the Monographs of the Ph. Eur.

Certificates issued by the EDQM

Contents of USP and JP Forums

Official Announcement -Rapid Implementation Corrigenda to the 2nd Edition - "Standard Terms" Products of fermentation Human plasma for fractionation Monographs on amino acids -Alanine -Aspartic acid -Arginine -Arginine hydrochloride -Cysteine hydrochloride monohydrate -Cystine -Glutamic acid -Histidine -Histidine hydrochloride monohydrate -Isolucine -Leucine -Lysine hydrochloride -Methionine -Phenylalanine -Proline -Serine -Threonine -Tryptophan -Tyrosine -Valine Lactitol monohydrate Sodium valproate Draft monographs for comment Bismuth subnitrate heavy Bismuth subsilicylate Calcitriol Carbamazepine Cell substrates for the production of vaccines for human use (5.2.3) Cholecalciferol Cholecalciferol concentrate (oily form) Cholecalciferol concentrate (powder form) Cholecalciferol concentrate (water-dispersible form) Conjugated estrogens Determination of water content in biologicals by coulometry Dextran 1 for injection Dextrin Ergocalciferol Etofenamate Etomidate Ferric chloride hexahydrate Flumetasone pivalate Flurbiprofen Gelatin Goserelin Hepatitis A (inactivated and Hepatitis B (rDNA) Vaccine (adsorbed) Hepatitis B vaccine (rDNA) Iopamidol Liquid chromatographic determination of actic acid in synthetic peptides Maltitol Maltitol, liquid Manganese sulphate monohydrate Mannitol Mefloquine hydrochloride Mesna Methylthionimium chloride for external and oral use Nimesulide Nitric acid Nomegestrol acetate Paracetamol Pethidine hydrochloride Potassium carbonate Premixes for medicated feeding stuffs for veterinary use Raman spectroscopy Silica, dental type Sorbitol Sorbitol, liquid (crystallising) Sorbitol, liquid (non crystallising) Sugar spheres Sulfanilamide Sulphuric acid Sumatriptan succinate Tiapride hydrochloride Tramazoline hydrochloride monohydrate Vitamin A Vitamin A concentrate, synthetic (oily form) Vitamin A concentrate, synthetic (powder form) Vitamin A concentrate, synthetic (solubilisate/microemulsion) White soft parafin Xylitol Yellow soft paraffin Enquiry

Monographs on biologicals: Replacement of the test for pyrogens by the test for bacterial endotoxins in biologicals National Pharmacopoeia Authorities