琥珀酸索利那新片分析方法及相关辅料质量标准及分析方法变更：1. 计划将

Solifenacin succinate and analysis of the new film standard and related accessories mass analysis method is changed: <br>1. the new film solifenacin succinate plan Dissolution Test Method The dissolution medium consisting of FDA reference "0.1N HCl" changed to "water." <br>2. Related Substances and residue on ignition analytical methods, quality standards BHT content, residue on ignition, related substances limits BHT quality standards according to the USP revision. <br>3.BHT quality standards residual solvents "not more than 2000 ppm of propylene glycol" is amended by "not more than 2000 ppm of isopropyl alcohol" and revised analysis <br>of other test items unchanged. "

Changes to the new tablet analysis method and related accessory quality standards and analysis methods:<br>1. It is planned to refer to the FDA for the solito detection method of the new tablet solina of succinic acid to modify the dissolved media from "0.1N HCl" to "water".<br>2. In accordance with the analysis method of analysis of substances and burning residues in the revised BHT quality standards of THE USP, the contents, burning residues, and relevant substance limits in the BHT quality standards.<br>3.Residual solvents in BHT quality standards are revised from "propylene glycol must not exceed 2000ppm" to "isopropanol must not exceed 2000ppm" and revised analytical methods<br>Other detection items remain unchanged. "

Change of analytical method, quality standard and analytical method for sulina Succinate Tablets and related excipients:<br>1. It is planned to refer to FDA to change the dissolution medium from "0.1N HCl" to "water".<br>2. Revise the analysis method of relevant substances and residue on ignition in BHT quality standard according to USP, content, residue on ignition and limit of relevant substances in BHT quality standard.<br>3. The residual solvent in BHT quality standard is revised from "propylene glycol shall not exceed 2000ppm" to "isopropanol shall not exceed 2000ppm" and the analytical method is revised<br>Other test items remain unchanged. "<br>