Case Study on Regulatory Approaches for New Degradation Impurity Exceeding ICH Thresholds in Solubilized Ibuprofen Capsules During Stability Testing

Authors : Gowri Sankararao Burle, Praneeth Rao Kakullamarri, Suresh Babu Kothamasu, Sudha Divya Madhuri Kallam, Anoop Bodapati

DOI : 10.56557/jirmeps/2024/v19i38936

Volume : 19

Issue : 3

Year : 2024

Page No : 70-82


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