Abstract

PROCESS VALIDATION OF LEVETIRACETAM 500 MG TABLET

Gaurav Kumar*, Ashok Kumar and Abhishek Bahuguna

ABSTRACT

The present study was carried out by using Levetiracetam 500 mg tablet. All in process parameters were validated in three batches. This was carried out through a systematic plan; critical parameters were optimized to produce a stable & robust manufacturing process. The data provided by technology supplier was studied extensively to understand product behavior & also verified feasibility of technology on available sets of facilities and equipments. The critical process variables studies during manufacturing of batches. Three validation batches of commercial batch size were taken successfully and monitored the in process critical parameters for commercial batches. Levetiracetam 500 mg tablet were prepared within specifications for meeting all quality attributes and loaded for stability study. If stability data and accelerated stability testing was found satisfactory & data matches with previous test result, so this shows successful execution of Process Validation of Levetiracetam 500 mg tablet.

Keywords: Levetiracetam 500m.