Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging

References

1. 1.↵
   1. Caballero B.

   1. Finglas P.

   1. Toldra F.

   1. Scanlan R. A.

   Nitrosamines. In: Encyclopedia of Food Science and Nutrition, 2nd ed.; Caballero B.; Finglas P.; Toldra F., Eds.; Academic Press: San Diego, CA, 2003; pp 4142–4147.
2. 2.↵
   1. Wainright T.

   The Chemistry of Nitrosamine Formation: Relevance to Malting and Brewing. J. Inst. Brew. 1986, 92 (1), 49–64.

   OpenUrl
3. 3.↵
   1. Magee P. N.,
   2. Barnes J. M.

   The Production of Malignant Primary Hepatic Tumors in the Rat by Feeding Dimethylnitrosamine. Br. J. Cancer 1956, 10 (1), 114–122.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Nollel L. M. L.

   1. Perera A. M. A.

   N-Nitrosamines. In: Chromatographic Analysis of the Environment, 3rd ed.; Nollel L. M. L., Ed.; CRC Press/Taylor & Francis Group: Boca Raton, FL, 2005; pp 420–447.
5. 5.↵
   1. Thresher A.,
   2. Foster R.,
   3. Ponting D. J.,
   4. Stalford S. A.,
   5. Tennant R. E.,
   6. Thomas R.

   Are All Nitrosamines Concerning? A Review of Mutagenicity and Carcinogenicity Data. Regul. Toxicol. Pharmacol. 2020, 116, 104749.

   OpenUrl
6. 6.↵
   1. Adamson R. H.,
   2. Chabner B. A.

   The Finding of N-Nitrosodimethylamine in Common Medicines. Oncologist 2020, 25 (6), 460–462.

   OpenUrl
7. 7.↵
   Nitrosation of Volatile Amines at the Workplace. In: The MAK Collection for Occupational Health and Safety: Annual Thresholds and Classifications for the Workplace; Wiley Online Library, 1990; vol. 1, pp 23–37.
8. 8.↵
   1. Capone D. G.,
   2. Bronk D. A.,
   3. Mulholland M. R.,
   4. Carpenter E. J.

   1. Bange H. W.

   Gaseous Nitrogen Compounds (NO, N₂O, N₂, NH₃) in the Ocean. In: Nitrogen in the Marine Environment, 2nd ed.; Capone D. G., Bronk D. A., Mulholland M. R., Carpenter E. J., Eds.; Elsevier: Amsterdam, 2008; pp 51–94.
9. 9.↵
   1. Fiddler W.,
   2. Pensabene J. W.,
   3. Doerr R. C.,
   4. Wasserman A. E.

   Formation of N-Nitrosodimethylamine from Naturally Occurring Quarternary Ammonium Compounds and Tertiary Amines. Nature 1972, 236 (5345), 307.

   OpenUrlPubMed
10. 10.↵
    MillionInsights. Amines Market Size & Forecast Report 2014–2025. Grand View Research, 2017.
11. 11.↵
    World Health Organization. WHO EMP/RHT/Information Note_Nitrosamine Impurities. WHO, 2019.
12. 12.↵
    European Medicines Agency. EMA/526934/2019: Lesson Learnt from Presence of N-Nitrosamine Impurities in Sartan Medicines. EMA: London, 2020.
13. 13.↵
    U.S. Food and Drug Administration. FDA-2020-D-1530: Control of N-Nitrosamine Impurities in Human Drugs. Center for Biologics Research. U.S. Department of Health and Human Services: Rockville, MD, 2020.
14. 14.↵
    European Medicines Agency. EMA/369136/2020: Procedure under Article 5(3) of Regulation EC (No) 726/2004, Nitrosamine impurities in human medicinal products, CHMP Assessment report. EMA: London, 2020.
15. 15.↵
    Council of Europe. Monograph 2034 on Substances for Pharmaceutical Use. In: European Pharmacopoiea (Ph. Eur) Supplement 10.4, Council of Europe: Strasbourg, France, 2020.
16. 16.↵
    Council of Europe. Analysis of N-Nitrosamine Impurities in Active Substances, Chapter 2.4.36. In: European Pharmacopoiea (Ph. Eur) Supplement 10.4, Council of Europe: Strasbourg, France, 2020.
17. 17.↵
    U.S. Pharmacopeial Convention, General Chapter <1469> Nitrosamine Impurities. Pharmacopeial Forum 2020, 46 (5).
18. 18.↵
    International Conference for Harmonisation, Guidance for Industry Q9: Quality Risk Management. ICH: Geneva, 2005.
19. 19.
    EMA Regulation. (EC) No 1223/2009 (as amended 2019) of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products.
20. 20.
    Council of Europe. Monographs on Candesartan cilexetil (2573), Irbesartan (2465), Losartan potassium (2232), Olmesartan medoxomil (2600), Valsartan (2423). In: European Pharmacopoiea (Ph. Eur) Supplement 10.4, Council of Europe: Strasbourg, France, 2020.
21. 21.↵
    International Conference for Harmonisation, Guidance for Industry M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH: Geneva, 2018.
22. 22.
    U.S. Food and Drug Administration. Compliance Policy Guide: CPG Sec 500.450. Volatile N-Nitrosamines in Rubber Baby Bottle Nipples. Center for Food Safety and Applied Nutrition. Office of Regulatory Affairs: Rockville, MD, 2005.
23. 23.
    Canada Consumer Products and Safety Act: SOR/2016-180 Infant Feeding Bottle Nipples Regulations. 2016.
24. 24.
    Commission Directive 93/11/EEC: Concerning the Release of the N-nitrosamines and N-nitrosatable Substances from Elastomer or Rubber Teats and Soothers. 1993.
25. 25.
    Occupational Safety and Health Administration. 29 CFR 1910.1003 Carcinogens. U.S. Department of Labor, 2005.
26. 26.
    Technische Regeln für Gefahrstoffe (TRGS 552) Krebserregende N-Nitrosamine Der Kat 1A Und 1B. GMBI 2018, (48),913–934.

    OpenUrl
27. 27.↵
    International Agency for Research on Cancer. Some N-Nitroso Compounds. IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Humans, Vol. 17; IARC, 1978; p. 125.
28. 28.↵
    Exxon Mobile. Model Vulcanization Systems for Butyl Rubber and Halobutyl Rubber Manual, 2017. https://www.exxonmobilchemical.com/en/ (accessed January 2, 2022).
29. 29.↵
    Nocil Limited, Arvind Mafatlal Group. Vulcanization & Accelerators. http://www.nocil.com (accessed January 2, 2022).
30. 30.↵
    Nocil Limited, Arvind Mafatlal Group. Antioxidants & Antidegradants. http://www.nocil.com. (accessed January 2, 2022)
31. 31.↵
    Akrochem. Technical Papers: Vulcanization Materials, Nitrosamines. https://www.akrochem.com/solutions_technical_papers.php (accessed January 2, 2022).
32. 32.↵
    Akrochem. Technical Papers: Vulcanization Materials, Accelerators and Accelerator Systems. https://www.akrochem.com/solutions_technical_papers.php (accessed January 2, 2022).
33. 33.↵
    1. Sheth P.,
    2. Desai R. N.

    Nitrosamine Generating Accelerators in Curing of Rubber. Int. J. Sci. Res. Dev. 2013, 1 (3), 529–531.

    OpenUrl
34. 34.↵
    1. Sheth P.,
    2. Desai R. N.

    Replacing TMTD with Nitrosamine Free TBzTD- Accelerator in Curing of Rubber. Int. J. Sci. Res. Dev. 2013, 1 (3), 532–535.

    OpenUrl
35. 35.↵
    International Conference for Harmonisation, Q2(R1): Validation of Analytical Procedures: Text and Methodology. ICH: Geneva, 2005
36. 36.↵
    1. Yan X.

    Unique Selective Detectors for Gas Chromatography: Nitrogen and Sulfur Chemiluminescence Detectors. J. Sep. Sci. 2006, 29 (12), 1931–1945.

    OpenUrlPubMedWeb of Science
37. 37.↵
    1. Norwood D. L.,
    2. Mullis J. O.,
    3. Feinberg T. N.,
    4. Davis L. K.

    N-Nitrosamines as “Special Case” Leachables in a Metered Dose Inhaler Drug Product. PDA J. Pharm. Sci. Technol. 2009, 63 (4), 307–321.

    OpenUrlAbstract/FREE Full Text
38. 38.↵
    1. Fang L.,
    2. Zhao C.

    Modeling the Permeation Rates of Organic Migrants through a Fluoropolymer Film. PDA J. Pharm. Sci. Technol. 2019, 73 (1), 70–82.

    OpenUrlAbstract/FREE Full Text