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European Pharmacopoeia / Ph. Eur. Commission | News | 17 April 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has decided to accept semi-quantitative High-Performance Thin-Layer Chromatography (HPTLC) tests as an alternative quality control which could be used instead of liquid chromatography (LC) assays in monographs on Traditional Chinese Medicines (TCM). The use of the HPTLC test, which aims at maintaining the level of quality control provided by the...
Certification of suitability (CEP) / Procedure of certification (general) | News | 10 April 2019 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Certification of suitability (CEP) / Procedure of certification (general) | News | 10 April 2019 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.2 before 30 June 2019.
Products and Services | News | 09 April 2019 | Strasbourg, France
The EDQM announces the availability of 4 New Ph. Eur. Reference Standards and 21 Replacement batches for Ph. Eur. Reference Standards.
EDQM / All activities | News | 08 April 2019 | Strasbourg, France
Due to the Easter weekend, the EDQM will be closed from Friday 19 April and will reopen Tuesday 23 April 2019.
Transfusion / Blood Quality Management system (B-QM) | News | 08 April 2019 | Strasbourg, France
The EDQM has made available on its website the proceedings of two of its recent training sessions on Quality Management Systems (QMS) and Statistical Process Control (SPC) for Blood Establishments.
European network of OMCLs / General European OMCLs Network activities | News | 03 April 2019 | Strasbourg, France
Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major reported contaminants, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), laboratories...
Reference Standard / Collection & Catalogue | News | 03 April 2019 | Strasbourg, France
A revised version of the monograph on Betacarotene (1069) published in Supplement 9.7. of the European Pharmacopeia (Ph. Eur.) has entered into force on 1 April 2019. This revised monograph requires the use of two new CRSs: Betacarotene CRS and Betacarotene for system suitability CRS.
European Pharmacopoeia / Monograph | News | 01 April 2019 | Strasbourg, France
With a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been undertaken. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described as clearly and consistently...
European Pharmacopoeia / Monograph | News | 01 April 2019 | Strasbourg, France
It has been brought to our attention that the conversion factor of 13.63 prescribed in the assay is inappropriate and leads to an overestimation of the content. Therefore, it has to be replaced by a factor of 13.03.
Reference Standard / General | News | 28 March 2019 | Strasbourg, France
Established specifically for their intended use, pharmacopoeial reference standards are thoroughly characterised and their uses may go beyond those described in compendia, although a clear-cut distinction between quantitative use and qualitative use is essential.
European Pharmacopoeia / Ph. Eur. Commission | News | 28 March 2019 | Strasbourg, France
During its 163rd session, held in Strasbourg on 19-20 March 2019, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Torbjörn Arvidsson (Sweden) as its Chair. As the 19th Chair of the Ph. Eur. Commission since its establishment in 1964, Prof. Arvidsson will be supported by two Vice-chairs who will be elected in June.
European network of OMCLs / General European OMCLs Network activities | News | 27 March 2019 | Strasbourg, France
The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant...
European Pharmacopoeia / General text/chapter | News | 08 March 2019 | Strasbourg, France
The revised limit test for arsenic (Method A, 2.4.2) was published in Supplement 9.4 of the European Pharmacopoeia and entered into force on 1 April 2018. Upon implementation, the EDQM was made aware of a problem with the suitability test (UV-visible absorbance) of the newly introduced reagent silver diethyldithiocarbamate solution R (1110401), as many laboratories reported difficulties in...
Products and Services | News | 07 March 2019 | Strasbourg, France
The EDQM announces the availability of 3 New Ph. Eur. Reference Standards and 24 Replacement batches for Ph. Eur. Reference Standards.