Quality Study On Bimatoprost Eye Drops

Drug of Bimatoprost eye drops is an effective for lowering intraocular pressure.Referring to the relevant technical guidelines and regulatory requirements,the study of formulation screening and confirmation was carried out,and the composition and proportion of the formulation were determined.The rationality of the formulation was investigated by the stress test and freeze-thaw study.The process parameters and the process control of intermediates were determined.The quality of Bimatoprost eye drops was systematically studied and the quality standard was established.According to the requirements of import drug registration standards,the main inspection indexes of Bimatoprost eye drops were controlled,including description,pH value,packing volumes,visible particles,sterility test,related substances and assay.The key quality items such as related substances,assay and preservative benzalkonium chloride content were focused on.The validation of the method provided experimental basis for quality control.Finally,according to the actual test results,a strict and reasonable quality standard was established.The quality of Bimatoprost eye drops was controlled from many aspects,so as to ensure the safety and effectiveness of clinical treatment.The results showed that:from the results of relevant investigation projects,it was confirmed that the quality of Bimatoprost eye drops was comparable to that on the market,and all quality standards met the requirements.