Bachhav, Rishikesh S. published the artcileAssay Test procedure as a CPP at Bulk-Solution stage – Esomeprazole Sodium Injection 40MG, Category: imidazoles-derivatives, the publication is World Journal of Pharmaceutical Research (2020), 9(5), 1565-1580, database is CAplus.
A review. To develop & validate the anal. 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 Bulk-solution in unit dosage form [Vials]. To test the bulk solution purity approx. 5-6 h 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 h. 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 anal. Assay Test procedure as a Critical Processing Parameters at the Bulk-Solution stage during manufacturing of Esomeprazole Sodium Injection 40mg.
World Journal of Pharmaceutical Research published new progress about 161796-78-7. 161796-78-7 belongs to imidazoles-derivatives, auxiliary class Membrane Transporter/Ion Channel,Proton Pump, name is Sodium (S)-6-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide, and the molecular formula is C17H18N3NaO3S, Category: imidazoles-derivatives.
Referemce:
https://en.wikipedia.org/wiki/Imidazole,
Imidazole | C3H4N2 – PubChem