Pharmaceutical Regulatory Affairs: Open Access

Department of Pharmaceutical Sciences, Amity Institute of Pharmacy, Amity University Haryana, Manesar, Gurugram -122413, India

Publications

• Research   
  Advancing Drug Chemical Stability: Unravelling Recent Developments and Regulatory Considerations
  Author(s): Shrikant Mahesh Sharma*, Rupali Sharma, Pankaj Chandrateya and Satish Sardana
  
  The present study explores the domain of chemical stability, with particular emphasis on semisolid pharmaceutical formulations. This paper presents a comprehensive analysis of the various factors that impact the stability of chemicals. These factors encompass environmental conditions, chemical interactions, pH levels and the materials used for packaging. The discourse also encompasses the utilization of analytical methodologies employed in stability testing, as well as the examination of case studies that shed light on the chemical stability of antifungal semisolid formulations. This paper critically analyses the current regulatory guidelines pertaining to stability testing, explores the difficulties encountered in adhering to these standards and investigates the practical implications of these challenges. This study investigates various strategies aimed at imp.. Read More»
  DOI: 10.37421/2167-7689.2024.13.408

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