Method for improving stability of low-concentration atropine ophthalmic preparation
AssigneeShenyang Xingqi Pharmaceutical Co., Ltd.
InventorsJidong Liu, Kun Gao, Jiuliang Wang, Qiang Yang
Life of this patent
Estimating the term…
Abstract
The application provides a method for improving the stability of a low-concentration atropine ophthalmic preparation, characterized by controlling the content of the total impurity ≤0.25% and/or a single impurity content of ≤0.05%, as well as a method for preparing the ophthalmic preparation, an atropine ophthalmic preparation prepared therefrom and use thereof in the manufacture of a medicament for preventing and/or treating vision defects.
Claims25
An atropine sulfate, wherein the content of the total impurity is ≤0.15% by weight and the content of a single impurity is ≤0.05% by weight upon formulation and remains upon storage at about 40° C. and about 75% relative humidity for at least about 6 months;
- wherein the single impurity comprises:
- impurity A:
Dependencies are inferred from the claim text.