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


Citation Data


Related Articles

Foetal outcome by the weeks of gestation in spontaneous vaginal delivery at term

Shree A Jani, Bhumika Dobariya, Ajesh N Desai

A case report: Nocardia otitidiscaviarum bacteraemia in a patient with metastatic lung adenocarcinoma

Sweta Shah, Pooja Thakkar, Sandeep Goyle, Shweta Jadhav

Multiplex PCR based detection of mecA, mecC and PVL gene in analysis of prevalence, circulation, transmission of MSSA/MRSA strains in a tertiary care hospital

S. H. Shifa Meharaj, S. Jayanthi, D. Danisvijay, A. Sujhithra, J. Perumal

Is oxidative stress an overlooked player in pyridoxine-dependent epilepsy? A focused review

Mazyar Yazdani, Katja Benedikte Prestø Elgstøen

First SPG48 case report in India with a novel mutation

Vikas Agrawal, Nissi Chrysolite Gongati*, Sonal Agrawal

A prospective study of B-Lynch suture in the management of atonic PPH at tertiary care centre

Shrikant Warade, Nimisha Sharma

Evaluation of degree of complexity, treatment need and outcome in a cohort- A retrospective study

Jagriti, Ajit Kumar Jaiswal, Girish Chaudhary, Jasmeet Kaur Ryait, Abhimanyu Kochhar, Priya Gupta

Consequence of smoking on hematological parameters in apparently healthy medical students

Mohammed A. Al Mufarah, Naif O. Alharbi, Anfal Y. Aqeeli, Rawan F. Bokhedher, Zahraa Al Mohsen

Effect of non-surgical periodontal treatment on gingival crevicular fluid and serum leptin levels in periodontally healthy chronic periodontitis and chronic periodontitis patients with type 2 diabetes mellitus

Charu R. Ahuja, Abhay P. Kolte, Rajashri A. Kolte, Madhur Gupta