Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications
Md. Sahab Uddin, Abdullah Al Mamun, Md. Tanvir Kabir, Jinnat Ruksana Setu, Sonia Zaman, Yesmin Begum, Md. Shah Amran
Journal of Advances in Medical and Pharmaceutical Sciences · pp. 1–17 · Published 7 Jul 2017
10.9734/JAMPS/2017/33924Abstract
The therapeutically performance of the pharmaceuticals must be constant and expectable. In order to claim a pharmaceutical to be a quality drug, it must fulfill certain standards and specifications. The quality of pharmaceuticals is strongly related to the patient’s well-being. Quality control (QC) is an historical process in which proof is obtained that the appropriate level of quality has been achieved. QC can have no effect on the quality of the pharmaceuticals. It is merely a measuring process. QC must ensure that all the finished products contain active ingredients that comply with the qualitative and quantitative composition of the finished product described in the product registration dossier. The books containing the standards for drugs and other related substances are known as pharmacopeias. The pharmacopoeias contain a list of drugs and other related substances regarding their source, description, tests, formulas for preparing the same, action and uses, doses, storage conditions, etc. Ophthalmic pharmaceuticals are agents specially designed to be applied to the eyes. Among the drug products, ophthalmic pharmaceuticals are most important since eye is very sensitive and is easily irritated if the composition of the ophthalmic pharmaceutical is not suitable. The QC tests for ophthalmic pharmaceuticals are different in the different pharmacopoeias like IP, BP, and USP. Therefore the aim of this review was to mention QC tests for ophthalmic pharmaceuticals based on quality requirements of the different pharmacopoeias.
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