Screening commercial available resins for simultaneous removal of two potential genotoxins from API methanolic streams-Reference-Cited by-同舟云学术

Screening commercial available resins for simultaneous removal of two potential genotoxins from API methanolic streams

Published:2018-12-25 Issue:18 Volume:54 Page:3005-3018
ISSN:0149-6395
Container-title:Separation Science and Technology
language:en
Short-container-title:Separation Science and Technology

Author:

Esteves Teresa¹,Ferreira Flávio A.¹^ORCID,Pina Mariana¹,Bandarra João²,Ferreira Frederico Castelo¹³

Affiliation:

1. iBB - Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Lisbon, Portugal

2. Hovione FarmaCiencia SA, R&D, Sete Casas, Loures, Portugal

3. The Discoveries Centre for Regenerative and Precision Medicine, Lisbon Campus, Instituto Superior Técnico - Universidade de Lisboa, Lisboa, Portugal

Funder

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Fundação para a Ciência e a Tecnologia

iBB - Institute for Bioengineering and Biosciences

Programa Operacional Regional de Lisboa 2020

Hovione PharmaScience Ltd

Publisher

Informa UK Limited

Subject

Filtration and Separation,Process Chemistry and Technology,General Chemical Engineering,General Chemistry

Link

https://www.tandfonline.com/doi/pdf/10.1080/01496395.2018.1556304

Reference35 articles.

1. Impurity profile tracking for active pharmaceutical ingredients: Case reports

2. Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control

3. Snodin, D. (2017) ICH Guideline M7 on mutagenic impurities in pharmaceuticals, Vol. 14, Nº 3; b) Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); December 2008.

4. Genotoxic Impurities in Pharmaceutical Manufacturing: Sources, Regulations, and Mitigation

Cited by 3 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Removal of Alkyl Sulfonates Using DABCO;Organic Process Research & Development;2021-11-18

2. Comparison and Combination of Organic Solvent Nanofiltration and Adsorption Processes: A Mathematical Approach for Mitigation of Active Pharmaceutical Ingredient Losses during Genotoxin Removal;Membranes;2020-04-16

3. Polybenzimidazole for Active Pharmaceutical Ingredient Purification: The Mometasone Furoate Case Study;Industrial & Engineering Chemistry Research;2019-05-24