Pharmacopoeia
A pharmacopoeia is a collection of recognized pharmaceutical rules about quality, testing, storage, and labeling of medicines and the substances used in their manufacture and testing, materials and methods.
Pharmacy History differentiates:
- Official pharmacopoeias ( pharmacopoeias ): They are based on a legislative act and is binding valid.
- Recipe arias: The rules described based on agreement between health professional groups. This includes pharmacopoeias to veterinary medicinal products.
This distinction is independent of the actual title of a Pharmacopoeia.
European Pharmacopoeia
(Referred Pharmacopoeia Europaea, Ph. Eur, in Switzerland as a European Pharmacopoeia) The basis for the European Pharmacopoeia was laid in 1965. The elaboration of the European Pharmacopoeia is the responsibility of the European Pharmacopoeia Commission. This consists of national delegations with a maximum of three members per country. The headquarters of the European Pharmacopoeia Commission (European Directorate for the Quality of Medicines, EDQM ), the Euro Europe in Strasbourg.
It consists of four parts:
- European Pharmacopoeia - General Section, Monograph groups ( Ph. Eur, Volume 1 )
- European Pharmacopoeia - monographs A- J (Ph. Eur, Volume 2 )
- European Pharmacopoeia - monographs K -Z ( Ph. Eur, Volume 3 )
- European Pharmacopoeia - Supplements
General and the monographs form the base. The European Pharmacopoeia is published in English and French and will be translated by the competent authorities of Germany, Austria and Switzerland in the German language. Currently the output version is valid 7.
Pharmacopoeia in Germany
The legal basis for the pharmacopoeia in Germany is § 55 of the German Medicines Act.
It consists of three pharmacopoeias:
- European Pharmacopoeia (7th Edition )
- German Pharmacopoeia (DAB 2012)
- Homeopathic Pharmacopoeia (HAB 2012)
The appearance of each official version will be published in the Federal Gazette.
The German Pharmacopoeia contains provisions that supplement the European Pharmacopoeia. Thus, for example, analytical procedures or drugs that are not common in all countries of the European Pharmacopoeia Commission, regulated. The European Pharmacopoeia establishes specifications for areas that are commonly used in Europe or require uniform regulation.
The pharmacopoeias are usually of a general part in which general rules and procedures of the various areas of pharmacy are set, and monographs from which definitions, test methods contained on identity and purity and storage requirements for drugs and chemicals.
The rules of the Pharmacopoeia are set by committees and published by the Federal Ministry of Health. The office of the pharmacopoeia commissions has its seat at the Federal Institute for Drugs and Medical Devices.
Not part of the Pharmacopoeia, and no official work is the German Medicines Codex (DAC 99), which contains production rules. It is standard procedure for Defektur and recipe.
Dates of publication of the German Pharmacopoeia
The German Pharmacopoeia ( DAB) has appeared in more than ten issues. The edition of 1872 was the first, rich unified German Pharmacopoeia (Pharmacopoeia Germanica ) after the founding of the German Empire in 1871. Both the first edition, as well as its predecessor, the Pharmacopoeia Germaniae of 1865, were still written in Latin. Later editions to the DAB 6 were called pharmacopoeia for the German Reich.
- Pharmacopoeia Germanica, editio I, 1872 ( Pharm Germ. Edit. I = DAB 1)
- Pharmacopoeia Germanica, editio altera, 1883 ( Pharm Germ. Edit. II DAB = 2)
- Pharmacopoeia Germanica, editio III, 1890 ( Pharm Germ. Edit. III DAB = 3)
- German Pharmacopoeia 4 (DAB 4), 1900
- German Pharmacopoeia 5 (DAB 5), 1910
- German Pharmacopoeia 6 (DAB 6 ), 1926
- German Pharmacopoeia 7 (DAB 7 ), 1964 ( East Germany ), 1968 (FRG)
- German Pharmacopoeia 8 (DAB 8 ), 1978
- German Pharmacopoeia 9 ( DAB 9 ), 1986
- German Pharmacopoeia 10 (DAB 10 ), 1991
In the GDR, the German Pharmacopoeia 7 appeared as a separate edition. Then in 1978, published in 1983, 1985 and 1987 pharmacopoeias under the name Pharmacopoeia of the German Democratic Republic ( GDR AB with indication of the year or even 2 AB -DDR with year ).
In addition to the major issues are still some official supplement books ( Erg.-B. ) published; these included " drugs that are not included in the German Pharmacopoeia ":
- Supplementary Volume 3 to DAB, Erg.-B. 3, 1894
- Expansion book 4 for DAB, Erg.-B. 4, 1916
- Expansion book 5 for DAB, Erg.-B. 5, 1930
- Expansion book 6 for DAB, Erg.-B. 6, 1941
In the course of further development of the European Community, the importance of the DAB takes in relation to the European Pharmacopoeia steadily. Recent editions of the DAB with updates in short intervals years are now referred to by the year of expenditure, for example:
- German Pharmacopoeia 2004 (DAB 2004)
- German Pharmacopoeia 2006 (DAB 2006)
From the pharmacopoeias numerous non-official comments are published.
Switzerland
The valid pharmacopoeia in Switzerland is the 7th edition of the European Pharmacopoeia ( Ph. Eur 7 ) with its Supplements as well as the 10th edition of the Swiss Pharmacopoeia ( Ph. Helv 10; Pharmacopoeia Helvetica 10 ) and its amendments.
Austria
In Austria, next to the Ph. Eur applies the Austrian Pharmacopoeia ( ÖAB - Austriaca Pharmacopoeia ) and the German HAB ( homeopathic pharmacopoeia ).
Homeopathic Pharmacopeia
The Homeopathic Pharmacopoeia ( HAB ) is similar to other pharmacopoeia and include a general part and a part with monographs. The monographs of the starting materials in addition to their usual quality standards also include information on potentiation up to that potency is from the weiterpotenziert with 43 % ethanol. The chapter " process technologies " in the general part contains, among other things, the description of manufacturing process of homeopathy, in part by Hahnemann, anthroposophy, organ therapy and Spagyrik based on historical preparation method or convention methods.
The most important manufacturing guidelines of the German and French homeopathic pharmacopoeia have been included in the European Pharmacopoeia. The HAB is a part of the pharmacopoeia according to § 55 of the German Medicines Act. It contains only rules that are not included in the European Pharmacopoeia ( European Pharmacopoeia ). An online edition does not yet exist. The official edition of the HAB can be purchased as a loose- leaf collection.