根据药审中心的补充资料要求需对琥珀酸索利那新片溶出度检测方法参考FDA

The additional information needed in claim drug trial center of the new film solifenacin succinate Dissolution Test Method FDA reference dissolution medium is water amended; of BHT standards related substance content, residue on ignition limits for tightening USP reference, and related substances Chi residue on ignition detecting method according to the revised USP. <br>2. D-FDF-QC-18023 " sodium carboxymethyl starch" deviation troubleshoot all residual solvents standard raw materials found BHT in isopropanol translated into propylene glycol, need to be corrected according to the number. "

根据药审中心的补充资料要求需对琥珀酸索利那新片溶出度检测方法参考FDA将溶出介质修订为水；BHT标准中有关物质、含量、炽灼残渣限度参考USP进行紧缩，有关物质和炽灼残渣检测方法按照USP进行修订。<br>2.根据编号为D-FDF-QC-18023“羧甲淀粉钠” 偏差对所有原辅料的残留溶剂标准进行排查发现BHT中异丙醇翻译成丙二醇，需进行更正。"

According to the supplementary information requirements of the drug Audit Center, it is necessary to revise the dissolution test method of sulina Succinate Tablets to water by referring to FDA; refer to USP for contraction of relevant substances, content and residue limit in BHT standard, and revise the test method of relevant substances and residue according to USP.<br>2. According to the deviation of d-fdf-qc-18023 "carboxymethyl starch sodium", the residual solvent standards of all raw and auxiliary materials were checked and found that isopropanol in BHT was translated into propylene glycol, which needs to be corrected. "