Abstract

CONCURRENT PROCESS VALIDATION OF THYROXINE SODIUM TABLETS 100 MCG

Dr. Praveen Kumar Ashok, Saurabh Pant, Gulfsha Parveen and Alan Khadka*

Abstract

This research project's main goal is to concurrently validate the Thyroxine Sodium Tablets IP process. Process validation investigations were carried out for the three successive batches of Thyroxine Sodium Tablets in the current investigation. At each stage, from the dispensing of raw ingredients, sifting, and mixing, to the last processes, which include packing, samples were taken, and various parameters were assessed and validated. These samples were then assessed using the HPLC technique in compliance with the protocol. After the findings were compiled, it was found that they satisfied the requirements while remaining inside the bounds.. From this validation study, it was concluded that no changes to the current manufacturing process were necessary. Only in the event that the procedures, instruments, or raw materials were changed would further validation be required.

Keywords: Thyroxine Sodium, Concurrent process validation, HPLC.