Newsroom Nitrosamine contamination
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published
The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...
New strategy for N-nitrosamine impurities in Ph. Eur. monographs
At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Regarding active substances The EPC agreed to delete the Production section covering N-nitrosamine impurities from existing individual...
Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and representatives of official medicines control laboratories (OMCLs) in Europe, as well as the US Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia, have co-authored an...
N-nitrosamine impurities in Ph. Eur. monographs: update on approach
Over the past few years, the texts of the European Pharmacopoeia (Ph. Eur.) have been adapted regularly to reflect the latest European regulatory requirements for N-nitrosamines. This included adding a Production statement covering the risk of N-nitrosamine formation to the Ph. Eur.’s five...
Important update on N-nitrosamine impurities in substances covered by CEPs
On 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. This update includes new...
CEP holders – How to submit a nitrosamine risk assessment
To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions. Minor revisions should be submitted for revised...
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines
At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), which now include a paragraph explaining the Ph. Eur. approach to N-nitrosamine...
OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines
In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...
New EDQM website, redesigned to better serve your needs – Now online!
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...
European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021
The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that were...
General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs
In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process. The Production section was...
Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation
The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the...
Nitrosamines – Update from the CEP procedure
In June 2018, a manufacturer detected N-nitrosodimethylamine (NDMA) in valsartan active substance batches. This led to multiple regulatory actions addressing the presence of NDMA and other nitrosamine impurities, initially in valsartan but later extended to many other active substances. As 2020...
Seven new reference standards available for the analysis of N-nitrosamine impurities
To support the implementation of the newly adopted general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42., previously listed as 2.4.36.), seven reference standards have been established and are available from the European Directorate for the Quality of Medicines...
Ph. Eur. Commission adopts a new general chapter for the analysis of N-nitrosamine impurities
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36). The general chapter should be seen as an analytical toolbox that proposes three procedures relying on more or...
Nitrosamines risk assessment: update for CEP holders
In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regards a potential nitrosamines formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the...
Last chance to comment: analysis of N-nitrosamine impurities
The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020. Given the exceptional circumstances due...
Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-nitrosamines
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36). In line with the Decision of the European Commission on 2 April 2019 (Annex I to the European Commission Decision C(2019) 2698 final) and...
Nitrosamine contamination: new web page on EDQM response
A new web page providing centralised access to all information related to nitrosamine contamination is now available on the EDQM website. It presents a general overview of the issue and provides details of the actions taken in the different sectors of activity concerned: the European...