特拉唑嗪片和原料药质量标准及分析方法变更： 1. 计划将原料药质量标准

Terazosin tablets and drug quality standards and analysis of changes: <br>1. The program will remove the heavy metal analysis and standard drug substance; <br>2. Program to increase product quality standards and related substances A determinating detection trait under item increasing the identification confirmation instructions, increased product laboratory address COA; <br>3. Program will delete the stability of quality standard hardness test items, the name of the revised degradation product related substances, known 4-amino-6,7-dimethoxy impurities -2 (1-piperazinyl) quinazoline was named terazosin related compound A limit changed from 0.5% to 0.4%, the new control two known impurities, increase the traits described item identification confirmation; <br>4. Program the increase in UV analysis to identify, to amend the relevant material items, remove hardness testing. "

特拉唑嗪片和原料药质量标准及分析方法变更： <br>1. 计划将原料药质量标准及分析方法中删除重金属；<br>2. 计划将成品质量标准中增加色谱鉴别A和有关物质检测，性状项下增加标识确认说明，产品COA中增加实验室地址；<br>3. 计划将稳定性质量标准中删除硬度检测项目，降解产物名称修订为有关物质，已知杂质4-氨基-6，7-二甲氧基-2（1-哌嗪基）喹唑啉命名为特拉唑嗪相关化合物A限度由0.5%变更为0.4%，新增两个已知杂质控制，性状项下增加标识确认说明；<br>4. 计划将分析方法中增加紫外鉴别，修订有关物质项目，删除硬度检测。"

Changes in quality standards and analytical methods of terazosin tablets and APIs:<br>1. It is planned to remove heavy metals from API quality standards and analysis methods;<br>2. It is planned to add chromatographic identification a and related substance detection to the quality standard of finished products, identification confirmation instructions under the item of properties, and laboratory address in the COA of products;<br>3. It is planned to delete the hardness test items in the stability quality standard, revise the name of degradation products to related substances, and name the known impurities 4-amino-6, 7-dimethoxy-2 (1-piperazinyl) quinazoline as terazosin related compound a limit from 0.5% to 0.4%, add two known impurities control, and add identification confirmation instructions under the property item;<br>4. It is planned to add UV identification to the analysis method, revise relevant substance items and delete hardness test. "<br>