Reference health
Presence of nitrosamine impurities in medicinal products
3/3 checkable references clean · checked 2026-07-22
Every reference with a DOI in the deposited reference list resolved to a known work in Crossref or DataCite at the dated check, and none carried a retraction, withdrawal, or removal notice.
15 without a DOI — not checked. A reference deposited without a DOI is never matched by title or guessed at; it stays outside the checked set, and this line discloses that.
The 3 checked references that resolve
resolves10.4149/gpb_2010_02_175
The binding affinity of carcinogenic N-nitrosodimethylamine and N-nitrosomethylaniline to cytochromes P450 2B4, 2E1 and 3A6 does not dictate the rate of their enzymatic N-demethylation
resolves10.1016/j.fct.2003.08.005
Intragastric formation and modulation of N-nitrosodimethylamine in a dynamic in vitro gastrointestinal model under human physiological conditions
resolves10.3390/nu7125505
Dietary Nitrates, Nitrites, and Nitrosamines Intake and the Risk of Gastric Cancer: A Meta-Analysis
The 15 references without a DOI — listed, not checked
no DOI — not checkedWorld Health Organization (WHO). Information Note Nitrosamine impurities [displayed 24 September 2020]. Available at https://www.who.int/medicines/publications/drugalerts/InformationNote_Nitrosamine-impurities/en/
no DOI — not checkedInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk [displayed 7 March 2021]. p. 6. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf
no DOI — not checkedEuropean Medicines Agency (EMA). Procedure under Article 5(3) of Regulation EC (No) 726/2004. Nitrosamine impurities in human medicinal products [displayed 24 September 2020]. Available at https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-assessment-report_en.pdf
no DOI — not checkedEuropean Medicines Agency (EMA). Lessons learnt from presence of N-nitrosamine impurities in sartan medicines [displayed 24 September 2020]. Available at https://www.ema.europa.eu/en/documents/report/lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines_en.pdf
no DOI — not checkedEuropean Medicines Agency (EMA). Assessment report Referral under Article 31 of Directive 2001/83/EC [displayed 24 September 2020]. Available at https://www.ema.europa.eu/en/documents/variation-report/sartans-article-31-referral-chmp-assessment-report_en.pdf
no DOI — not checkedDirective 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [displayed 7 March 2021]. Available at https://eur-lex.europa.eu/eli/dir/2001/83/
no DOI — not checkedEuropean Medicines Agency (EMA). EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site [displayed 24 September 2020]. Available at https://www.ema.europa.eu/en/news/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan-ema-national
no DOI — not checkedEuropean Medicines Agency (EMA). Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities [displayed 24 September 2020]. Available at https://www.ema.europa.eu/en/news/sartan-medicines-companies-review-manufacturing-processes-avoid-presence-nitrosamine-impurities
no DOI — not checkedEuropean Medicines Agency (EMA). Nitrosamine impurities [displayed 24 September 2020]. Available at https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities#metformin-containing-medicines-section
no DOI — not checkedWorld Health Organization (WHO). Guidelines for Drinking-water Quality. 3rd ed. Vol 1, Incorporating first and second addenda. Geneva; WHO; 2008.
no DOI — not checkedAgency for Medicinal Products and Medical Devices of Croatia (HALMED). Medicinal products database [displayed 24 September 2020]. Available at https://www.halmed.hr/Lijekovi/Baza-lijekova/
no DOI — not checkedAgency for Medicinal Products and Medical Devices of Croatia (HALMED). Obavijest o nestašici lijekova s djelatnom tvari ranitidin [Notice of shortage of drugs with the active substance ranitidine, in Croatian] [displayed 24 September 2020]. Available at https://www.halmed.hr/Novosti-i-edukacije/Novosti/2019/Obavijest-o-nestasici-lijekova-s-djelatnom-tvari-ranitidin-/2239
no DOI — not checkedAgency for Medicinal Products and Medical Devices of Croatia (HALMED). Obustava izvršenja odobrenja za stavljanje u promet lijekova koji sadrže djelatnu tvar ranitidin u Europskoj uniji [Suspension of the marketing authorization for medicinal products containing the active substance ranitidine in the European Union, in Croatian] [displayed 24 September 2020]. Available at https://www.halmed.hr/Novosti-i-edukacije/Novosti/2020/Obustava-izvrsenja-odobrenja-za-stavljanje-u-promet-lijekova-koji-sadrze-djelatnu-tvar-ranitidin-u-Europskoj-uniji/2360/
no DOI — not checkedAgency for Medicinal Products and Medical Devices of Croatia (HALMED). Izvješće o potrošnji lijekova u Republici Hrvatskoj u 2018. [Report on medicinal product utilization in the Republic of Croatia in 2018, in Croatian] [displayed 24 September 2020]. Available at https://halmed.hr/Novosti-i-edukacije/Publikacije-i-izvjesca/Izvjesca-o-potrosnji-lijekova/Izvjesce-o-potrosnji-lijekova-u-Republici-Hrvatskoj-u-2018/
no DOI — not checkedAgency for Medicinal Products and Medical Devices of Croatia (HALMED). Izvješće o potrošnji lijekova u Republici Hrvatskoj u 2019. [Report on medicinal product utilization in the Republic of Croatia in 2019, in Croatian] [displayed 24 September 2020]. Available at https://halmed.hr/Novosti-i-edukacije/Publikacije-i-izvjesca/Izvjesca-o-potrosnji-lijekova/Izvjesce-o-potrosnji-lijekova-u-Republici-Hrvatskoj-u-2019/
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