US 12,303,500 B2
Method for improving stability of low-concentration atropine ophthalmic preparation
Jidong Liu, Shenyang (CN); Kun Gao, Shenyang (CN); Jiuliang Wang, Shenyang (CN); and Qiang Yang, Shenyang (CN)
Assigned to SHENYANG XINGQI PHARMACEUTICAL CO., LTD., Shenyang (CN)
Appl. No. 17/279,554
Filed by SHENYANG XINGQI PHARMACEUTICAL CO., LTD., Shenyang (CN)
PCT Filed Sep. 10, 2019, PCT No. PCT/CN2019/105010
§ 371(c)(1), (2) Date Mar. 24, 2021,
PCT Pub. No. WO2020/063320, PCT Pub. Date Apr. 2, 2020.
Claims priority of application No. 201811112830.8 (CN), filed on Sep. 25, 2018.
Prior Publication US 2021/0393609 A1, Dec. 23, 2021
Int. Cl. A61K 31/46 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01); A61K 47/54 (2017.01)
CPC A61K 31/46 (2013.01) [A61K 9/0048 (2013.01); A61K 47/02 (2013.01); A61K 47/186 (2013.01); A61K 47/36 (2013.01); A61K 47/38 (2013.01); A61K 47/547 (2017.08)] 25 Claims
 
1. 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:

OG Complex Work Unit Chemistry