What is European Pharmacopoeia monograph?
It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
What is a monograph in Pharmacopoeia?
A pharmacopoeial monograph is a compiled data about Active Pharmaceutical Ingredients (API) or Products (APP) with its identification tests, assay method, impurity profile, test for impurity, solubility, etc.
How do you cite European Pharmacopoeia?
The official abbreviation is ‘Ph. Eur. ‘ and not ‘EP’ (which is registered for the European Parliament). A good example of a reference would be: Ph.
What is the current version of the European Pharmacopoeia?
The 10th Edition of the European Pharmacopoeia, which is applicable in 38 European countries from 1 January 2020 and is used in over 100 countries worldwide, is now available!
Is BP and Ph Eur same?
It contains all texts and monographs of the European Pharmacopoeia (signposted with a chaplet of stars), as well as the national standards developed by the BP. Unsurprisingly, this means the BP contains a lot of information.
What is monograph used for?
Unlike a textbook, which surveys the state of knowledge in a field, the main purpose of a monograph is to present primary research and original scholarship ascertaining reliable credibility to the required recipient. This research is presented at length, distinguishing a monograph from an article.
Who is the author of the European Pharmacopoeia?
Council of Europe
Author: Council of Europe.; European Pharmacopoeia Commission.; European Directorate for the Quality of Medicines & Healthcare.
How do you reference a pharmacopoeia?
Pharmacopoeias (print) #, volume name. Place of publication: Publisher; Year of publication. Entry title; Page/s of entry.
What does a monograph contain?
Monographs provide basic pharmacokinetic information about each drug, some metabolic information and some review of literature on the compound.
What is BP monograph?
BP monographs are designed for products that are manufactured within the quality framework for medicinal products. When applied within this framework, the identification test (or tests) in the monograph are sufficient to confirm that the drug product contains the drug substance on the label.
How many monographs are in the European Pharmacopoeia 10th edition?
The 10th Edition (including Supplement 10.6) contains 2455 monographs (including dosage forms), 382 general texts (including general monographs and methods of analysis) and about 2860 descriptions of reagents.
When does the European Pharmacopoeia 5.8 come out?
The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of the general chapter on Pharmacopoeial harmonisation (5.8) which will be published in the upcoming 10th Edition (implementation date 1 January 2020).
Is the Council of Europe Convention on Pharmacopoeia binding?
These standards are legally binding – as laid down in the Council of Europe Convention on the Elaboration of a European Pharmacopoeia and in EU and national pharmaceutical legislation. Ph. Eur. quality standards become mandatory on the same date in all States Parties to the convention.
Who is the chair of the European Pharmacopeia Commission?
164th Session of the European Pharmacopeia Commission and election of… Following the election of its new Chair, Prof. Torbjörn Arvidsson, at its March session, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Salvador Cañigueral as its first Vice-chair for a term of three years (2019-2022).