What does Ph Eur mean?
What does Ph Eur mean?
European Pharmacopoeia
The European Pharmacopoeia (Ph. Eur.) is a single reference work for the quality control of medicines. The official standards it contains provide a scientific basis for quality control during the entire life cycle of a product.
What is the current version of Ph Eur?
The 10th edition, currently applicable, was published in July 2019. The Ph. Eur. is applicable in 39 European countries and used in over 100 countries worldwide.
How do I access European Pharmacopoeia?
To gain access, you must have an EDQM account, which you can enter using your e-mail address and associated password. In the case of the European Pharmacopoeia electronic version, your account must also be associated with a subscription key (i.e. EPID code).
Which is the latest British Pharmacopoeia?
The BP 2019 supersedes the BP 2018 and becomes legally effective on 1 January 2019. This edition incorporates new BP and European Pharmacopoeia monographs and a significant number of revised monographs. Four new monographs for unlicensed formulations and two new monographs for herbal preparations.
What is the difference between British Pharmacopoeia and European Pharmacopoeia?
The BP contains thousands of monographs and one of our areas of expertise is in finished products, while the EP predominantly focuses on starting materials and active pharmaceutical ingredients.
What is difference BP and IP?
Drugs manufactured in India have to be labelled with the mandatory non-proprietary drug name with the suffix I.P. This is similar to the B.P. suffix for British Pharmacopoeia and the U.S.P. suffix for the United States Pharmacopeia.
Which British Pharmacopoeia is linked with vet?
The monographs of the European Pharmacopoeia (as amended by Supplements published by the Council of Europe) are reproduced either in the British Pharmacopoeia, or in the associated edition of the British Pharmacopoeia (Veterinary).
When do you need a ph.eur.test?
Ph. Eur. tests are reference methods, essential in cases of dispute ¾Compliance is required, but alternative methods may be used as long as they lead to the same pass/fail result. It is the responsibility of the user to demonstrate their suitability. Approval of the competent authority is necessary in many cases.
When does the revised ph.eur.chapter tablets come out?
The revised European Pharmacopoeia (Ph. Eur.) Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. New and revised texts of Supplement 9.3 will be implemented on January 1, 2018 (unless otherwise indicated).
What is the pH in the European Pharmacopoeia?
European Pharmacopoeia, Fourth Edition (2002) 2. Methods of analysis. 2.2.3. POTENTIOMETRIC DETERMINATION OF PH The pH is a number, which represents conventionally the hydrogen ion concentration of an aqueous solution. For practical purposes, its definition is an experimental one.
How is content uniformity of dosage units tested?
The test for content uniformity of preparations presented in dosage units is based on the assay of the individual contents of active substance(s) of a number of dosage units to determine whether the individual contents are within the limits set. The content uniformity method may be applied in all cases.