The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals

Author:

Schlingemann JoergORCID,Burns Michael J.ORCID,Ponting David J.ORCID,Martins Avila CarolinaORCID,Romero Naiffer E.,Jaywant Mrunal A.ORCID,Smith Graham F.ORCID,Ashworth Ian W.ORCID,Simon Stephanie,Saal Christoph,Wilk AndrzejORCID

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference70 articles.

1. Pathways for N-nitroso compound formation: secondary amines and beyond;López-Rodríguez;Org Process Res Dev,2020

2. EMA 2021. CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline. https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-champix-varenicline-lots-be-recalled-due-presence_en.pdf. Accessed November 23, 2022.

3. FDA 2021. Pfizer expands voluntary nationwide recall to include all lots of CHANTIX® (Varenicline) tablets due to N-nitroso varenicline content. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n. Accessed November 23, 2022.

4. Health Canada 2022. Pfizer recalls Inderal-LA (propranolol hydrochloride) capsules due to a nitrosamine impurity. https://recalls-rappels.canada.ca/en/alert-recall/pfizer-recalls-inderal-propranolol-hydrochloride-capsules-due-nitrosamine-impurity. Accessed November 23, 2022.

5. FDA 2022. Sandoz, Inc. Issues nationwide recall of 13 lots of orphenadrine citrate 100 mg extended release tablets due to presence of a nitrosamine impurity. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due. Accessed November 23, 2022.

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3