Identification of an Adduct Impurity of an Active Pharmaceutical Ingredient and a Leachable in an Ophthalmic Drug Product Using LC-QTOF-Reference-Cited by-同舟云学术

Identification of an Adduct Impurity of an Active Pharmaceutical Ingredient and a Leachable in an Ophthalmic Drug Product Using LC-QTOF

Published:2019-10 Issue:10 Volume:108 Page:3187-3193
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Gollapalli Ramarao,Singh Gagandeep,Blinder Alejandro,Brittin Jeremiah,Sengupta Arijit,Mondal Bikash,Patel Milan,Pati Biswajit,Lee James,Ghode Amit,Kote Mahesh

Funder

Akorn Pharmaceuticals Inc.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference23 articles.

1. Analytical advances in pharmaceutical impurity profiling;Holm;Eur J Pharm Sci,2016

2. Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – current challenges and approaches;Broschard;Regul Toxicol Pharmacol,2016

3. The Product Quality Research Institute (PQRI) leachables and extractables working group initiatives for parenteral and ophthalmic drug product (PODP);Paskiet;PDA J Pharm Sci Technol,2013

4. Q3B (R2): Impurities in New Drug Products,2006

5. ICH Harmonised Tripartite Guideline;Pharmaceutical Development, Q8(R2),2005

Cited by 8 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. Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review;Journal of Packaging Technology and Research;2023-10

2. Identification, Isolation and Structural Elucidation of Benzophenone, Methyl-2-Benzoyl Benzoate and 1-Hydroxycyclohexyl Phenyl Ketone as Leachable in Diclofenac Ophthalmic Solution by Chromatographic and Spectral Analysis;2023

3. Applications – Pharmaceutical Drug Products – Packaging;Extractables and Leachables;2022-07-22

4. Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices;ACS Biomaterials Science & Engineering;2022-02-16

5. Identification, Isolation and Characterization of Degradation Products (DPs) in Osimertinib Mesylate (OSM) Tablets by UHPLC-IMS-QTOF-MS, and NMR: Evaluation of Genotoxicity for OSM and DPs;Analytical Chemistry Letters;2022-01-02