Newsroom Nitrosamine contamination
Detection of N-nitrosamine impurities: the Ph. Eur. launches a public consultation on the revised general monograph Substances for pharmaceutical use (2034)
The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated by the European Medicines Agency (EMA) in September 2019 under...
EDQM launches a new HelpDesk
As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer...
Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines
Since July 2018, EDQM has been actively involved in activities related to the detection and control of nitrosamine impurities in sartan active substances (APIs) with a tetrazole ring for which there are CEPs. These activities have included contacting CEP holders to request data and corrective...
EDQM’s actions to evaluate impact of impurity in ranitidine medicines
The EDQM is aware of a quality defect in ranitidine medicines used to treat heartburn and stomach ulcers. An impurity called N-nitrosodimethylamine (NDMA) was detected in some of these medicines. Last week, the European Medicines Agency (EMA) announced that it was starting a review of medicines...
First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)
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...
Update on the review of CEP applications for sartans (18 January 2019)
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:...
Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines
Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active...
New OMCL method for simultaneous determination of NDMA and NDEA in sartans
Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) potentially present in valsartan and other sartan...
OMCLs release three methods for determination of NDMA in sartans
Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different...
Update on detection of nitrosamines in valsartan and validated testing method
The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates...
EDQM’s actions to evaluate impact of impurity in active substance valsartan
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe. Earlier this month, a pan-European alert system has been triggered by...