First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)

EDQM 03/04/2019 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...

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New monograph on Betacarotene and new CRSs

EDQM 03/04/2019 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. These new...

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Fast track revision of monograph Dipotassium clorazepate monohydrate (0898)

EDQM 01/04/2019 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. In order to ensure the continuous supply of dipotassium clorazepate API to the...

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Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines

EDQM 01/04/2019 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...

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Joint EDQM-USP symposium illustrates use of pharmacopoeial reference standards

EDQM 28/03/2019 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. For example, compendial assay...

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Outcome of the 163rd Session of the European Pharmacopoeia Commission

EDQM 28/03/2019 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...

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20 years of sampling & testing programme for medicines authorised for the EU

EDQM 27/03/2019 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...

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FOLLOW-UP – Issue with revision of general chapter on Arsenic (2.4.2) in Ph. Eur.

EDQM 08/03/2019 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...

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3 new Ph. Eur. Reference Standards (RS) and 24 replacement batches released in February 2019

EDQM 07/03/2019 Strasbourg, France

The EDQM announces the availability of: 3 New Ph. Eur. Reference Standards:Y0001784 Nimodipine for peak identification, Y0002087 Loperamide for system suitability, Y0002056 Tetrahydropalmatine 24 Replacement batches for Ph. Eur. Reference Standards: A0800000 Amoxicillin trihydrate, C2175000...

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Slovenia signs the MEDICRIME convention

EDQM 06/03/2019 Strasbourg, France

Slovenia signed the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS 211, MEDICRIME Convention) on 6 March 2019. The Convention now counts 14 signatory countries as well as 15 countries who have ratified it. The...

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The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8.

EDQM 18/02/2019 Strasbourg, France

The revised part is reproduced here after: The instrument qualification is carried out according to established quality system procedures, for example using a suitable certified reference material. Sodium aminosalicylate dihydrate for equipment qualification CRS may be used when proceeding by...

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Call for experts: Join the Ph. Eur. Network!

EDQM 13/02/2019 Strasbourg, France

The EDQM is renewing its call for expressions of interest to join the European Pharmacopoeia (Ph. Eur.) as an independent scientific expert. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates),...

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Elemental impurities reference standards: leaflets now include expanded uncertainty

EDQM 12/02/2019 Strasbourg, France

The EDQM has updated the leaflets of its reference standards for elemental impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS) with further information to facilitate their use and make traceability transparent. The mass fractions of the assigned...

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Montenegro ratifies convention against trafficking in human organs

EDQM 11/02/2019 Strasbourg, France

Montenegro ratified the Council of Europe Convention against Trafficking in Human Organs on 5 February 2019. The Convention will commence having legal effect in the country as of 1 June 2019. The Convention identifies various activities constituting human organ trafficking which ratifying member...

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29 new Ph. Eur. Reference Substances (RS) and 18 replacement batches released in January 2019

EDQM 07/02/2019 Strasbourg, France

The EDQM announces the availability of: 29 New Ph. Eur. Reference Substances: Y0002048 Everolimus, Y0002053 Achyranthes bidentata root dry extract for system suitability, Y0002054 Beta-Ecdysterone, Y0002057 Corydalis rhizome dry extract, Y0002076 Asparagine impurity C, Y0002078 moxifloxacin for...

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Update on the EDQM review of CEP applications for sartan substances (4 February 2019)

EDQM 04/02/2019 Strasbourg, France

Following new information received recently about the presence of nitrosamine impurities in a drug substance covered by a certificate of suitability (CEP), the EDQM has taken immediate action and suspended CEP R1-CEP 2009-247-Rev 02/losartan potassium, form I, held by HETERO LABS, Limited, due to...

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Updated Technical Guide for elaborating monographs on vaccines and sera for human use

EDQM 31/01/2019 Strasbourg, France

At its 162nd session, the European Pharmacopoeia (Ph. Eur.) Commission approved a new edition of the Guide for the elaboration and use of monographs on vaccines and immunosera for human use. The Guide provides guidance to experts on the information to be included in Ph. Eur. monographs related to...

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The revised Oxytetracycline hydrochloride (0198) monograph to be published in the Ph. Eur. 10.0

EDQM 25/01/2019 Strasbourg, France

A revised version of the monograph on Oxytetracycline hydrochloride (0198) has been adopted by the European Pharmacopoeia Commission and will be published in the upcoming 10th Edition. This revised version will include impurity F as a specified impurity and will introduce a limit of maximum 1.0%...

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Ph.Eur. Supplement 9.8 available now

EDQM 24/01/2019 Strasbourg, France

The 9.8 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2019.

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Update on the review of CEP applications for sartans (18 January 2019)

EDQM 18/01/2019 Strasbourg, France

Following new information received recently by EDQM about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate corrective actions will have been implemented by the relevant company:...

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