Evaluation of Starting Materials for PMIs (Potentially Mutagenic Impurities): A Vortioxetine Case Study-Reference-Cited by-同舟云学术

Evaluation of Starting Materials for PMIs (Potentially Mutagenic Impurities): A Vortioxetine Case Study

Published:2018-01-24 Issue:2 Volume:22 Page:125-135
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Kragelj Lapanja Nevenka¹²^ORCID,Zupančič Borut¹,Toplak Časar Renata¹,Jurca Sabina¹,Doljak Bojan²

Affiliation:

1. Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

2. Faculty of Pharmacy, Aškerčeva 7, 1000 Ljubljana, Slovenia

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.7b00239

Reference39 articles.

1. EMEA/CHMP, Guideline on the Limits of Genotoxic impurities, CPMP/SWP/5199/02. 2006.

2. ICH M7 (R1), Step 4, March 31, 2017.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_R1_Addendum_Step_4_2017_0331.pdf(accessed May 2017).

3. A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions

4. Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material

5. ICH Q7, Step 4, November 10, 2000.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf(accessed May 2017).

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