Abstract

ASSAY TEST PROCEDURE AS A CPP AT BULK-SOLUTION STAGE - ESOMEPRAZOLE SODIUM INJECTION 40MG

Rishikesh S. Bachhav* and Santoshkumar R. Mulik

Abstract

To develop & validate the analytical Assay Test procedure as a Critical Processing Parameters at the Bulk-Solution stage during manufacturing of Esomeprazole Sodium Injection 40mg. As per current available literature and the references, Esomeprazole active substance is available in market in five forms, i.e. Esomeprazole as Plan active [Tablet]; Esomeprazole Magnesium Trihydrate [Tablet, Capsule Delayed Release]; Esomeprazole Potassium [Tablet & Capsule]; Esomeprazole Strontium [Capsule Delayed Release] and Esomeprazole Sodium [Injectable]. Assay test for Active & other dosage forms [Tablet, Capsule] were available. Available Test procedure are based on either Potentiometory Titration or HPLC basis. Esomeprazole Sodium Injection 40mg Dosage form is not in any pharmacopeia. As per available reference & literature assay test method for intermediate testing & finished product is based on HPLC. Intermediate testing [In-Process Testing] require as Critical Process Parameters [CPP] to ensure the quality i.e. appropriate bulk-solution purity, before to proceed for filling of Bulksolution in unit dosage form [Vials]. To test the bulk solution purity approx. 5-6 hours required. Which leads to hold the Bulk solution, further it impact & may risk bio-burdon of bulk solution. Also it impact & reduce the productivity of line by 5-6 hours. HPLC testing required special skilled manpower & cost. Considering all above concerns of current available test methods; this article project is selected to develop & validate the analytical Assay Test procedure as a Critical Processing Parameters at the Bulk-Solution stage during manufacturing of Esomeprazole Sodium Injection 40mg.

Keywords: Validation, Intermediate Test, In-process Test, CPP - Critical Process Parameters, Injectable Dosage Form.