残留溶剂专题①｜岛津SH-I-624Sil MS助力精益生产-医疗器械网

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残留溶剂专题①｜岛津SH-I-624Sil MS助力精益生产

来源：岛津（上海）实验器材有限公司分类：会展 2024-04-26 11:30:08 6阅读次数

2024

第1期

第一期

岛津SH-I-624Sil MS

助力精益生产

残留溶剂怎么测？

何为残留溶剂？

在原料药或辅料生产及制剂制备过程中使用或产生的挥发性有机物。这些溶剂在实际生产工艺中无法除尽。

残留溶剂分类？

残留溶剂一般分为I、II、III、IV类：

为何需要检测？

残留溶剂无实际治疗助益，当在药品中含量高于安全值时会危害人体或环境；

残留溶剂在物料中可能影响物料安全性和质量稳定性，是药品关键质量属性。

有何法规支持？

ICH Q3C(R8)：杂质：残留溶剂的指导原则(立足各国药典之上)

《美国药典》USP<467>有机挥发性杂质：残留溶剂的限制

《中国药典》ChP<0861>残留溶剂测定法

《欧洲药典》EP<5.4.>残留溶剂通则

《日本药典》JP<2.46>残留溶剂检测

方案设计情况？

方法选择

参考USP<467>和ChP<0861>相结合

仪器选择

多使用气相色谱仪+FID检测器

柱子选择

多使用6%氰丙基苯基/94%二甲基聚硅氧烷(624)

载气选择

多使用N₂(经济)

溶剂选择

多使用DMSO/DMF(溶解能力强)

进样方式

多使用顶空进样(大部分组分沸点低、挥发性强)

最终方案

HS-GC-FID+SH-I-624Sil MS、N2做载气、DMSO做溶剂

优势对比

I类、II类A、II类B、III类与市售624气相色谱柱对比

方案分析效果？

小编今天给大家带来的是同仪器及方法、相同规格(30m x 0.32mm x 1.8 μm)624色谱柱下 I、II类A分离效果对比。（方法参考USP<467>）

01 I 类残留溶剂

II 类A残留溶剂

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[8]未定义数组索引: page
[8]未定义数组下标: 0
[2]Declaration of app\common\model\News::getAllList($filter = Array, $limit = 16, $order = Array, $with = Array) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\Company::getAllList($filter = Array, $limit = 20) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8]未定义数组索引: center
[8]Only variables should be passed by reference
[2]Declaration of app\common\model\NewsComment::getAllList($filter = Array, $limit = 16) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8192]Function create_function() is deprecated
[8192]Function create_function() is deprecated
[8]未定义数组索引: area
[8]未定义数组索引: st
[2]Declaration of app\common\model\Topic::getList($filter = Array) should be compatible with app\common\model\BaseModel::getList($filter = Array, $sort = Array)
[2]Declaration of app\common\model\Topic::getAllList($filter = Array, $field = 'id,md5,tit...', $limit = 0) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\TopicInfoList::getAllList($filter = Array, $limit = 8) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8]未定义数组索引: center
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: goods_list
[8]未定义数组下标: 0
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: wtt_list

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[ SQL ] SHOW COLUMNS FROM `news_category` [ RunTime:0.001077s ]
[ SQL ] SELECT `id`,`name` FROM `news_category` WHERE `is_show` = 1 [ RunTime:0.000205s ]
[ SQL ] SELECT * FROM `news_category` WHERE `parent_id` = 0 AND `is_show` = 1 ORDER BY `sort` ASC,`id` DESC [ RunTime:0.000259s ]
[ SQL ] SHOW COLUMNS FROM `company` [ RunTime:0.001157s ]
[ SQL ] SHOW COLUMNS FROM `news` [ RunTime:0.001010s ]
[ SQL ] SELECT * FROM `news` WHERE `md5` = 'd1e5e03efa9010e5' AND `review_status` = 1 LIMIT 1 [ RunTime:0.000344s ]
[ SQL ] SHOW COLUMNS FROM `user_info` [ RunTime:0.000996s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` = 203 [ RunTime:0.000918s ]
[ SQL ] SELECT * FROM `company` WHERE `id` = 321 [ RunTime:0.000220s ]
[ SQL ] SHOW COLUMNS FROM `news_text` [ RunTime:0.000831s ]
[ SQL ] SELECT * FROM `news_text` WHERE `news_id` = 7458 [ RunTime:0.034604s ]
[ SQL ] SHOW COLUMNS FROM `news_belong_category` [ RunTime:0.001141s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7458 [ RunTime:0.002345s ]
[ SQL ] SELECT * FROM `news_category` WHERE `id` IN (9) [ RunTime:0.000217s ]
[ SQL ] SHOW COLUMNS FROM `user_follow` [ RunTime:0.000928s ]
[ SQL ] SELECT `id` FROM `user_follow` WHERE `user_id` IS NULL AND `follow_user_id` = 203 LIMIT 1 [ RunTime:0.000263s ]
[ SQL ] SHOW COLUMNS FROM `news_comment` [ RunTime:0.000845s ]
[ SQL ] SELECT * FROM `news_comment` WHERE `news_id` = 7458 AND `parent_id` = 0 ORDER BY `id` DESC [ RunTime:0.000285s ]
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[ SQL ] SELECT * FROM `news` WHERE `is_show` = 1 AND `review_status` = 1 AND `id` IN (7458,7662,7588,7510,7490,7429,7380,7378,7374,7373) ORDER BY field(id,7458,7662,7588,7510,7490,7429,7380,7378,7374,7373) [ RunTime:0.000512s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (203,561,476,378,469,194,302,256,789,308) [ RunTime:0.001145s ]
[ SQL ] SHOW COLUMNS FROM `topic` [ RunTime:0.001019s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `topic` WHERE `review_status` = 1 ORDER BY `id` DESC LIMIT 4 [ RunTime:0.000214s ]
[ SQL ] SHOW COLUMNS FROM `topic_info_list` [ RunTime:0.000906s ]
[ SQL ] SELECT * FROM `topic_info_list` WHERE `topic_id` = 1 ORDER BY `id` DESC LIMIT 2 [ RunTime:0.000206s ]
[ SQL ] SELECT * FROM `news` WHERE `id` IN (864,849) [ RunTime:0.000263s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `news` WHERE `review_status` = 1 AND `is_show` = 1 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000231s ]
[ SQL ] SHOW COLUMNS FROM `user` [ RunTime:0.000884s ]
[ SQL ] SELECT `a`.* FROM `user` `a` INNER JOIN `news` `b` ON `a`.`id`=`b`.`user_id` GROUP BY `a`.`id` ORDER BY `b`.`id` DESC LIMIT 10 [ RunTime:0.015878s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (466,458,209,372,521,819,385,657,412,274) [ RunTime:0.001181s ]
[ SQL ] SHOW COLUMNS FROM `seo` [ RunTime:0.001019s ]
[ SQL ] SELECT * FROM `seo` WHERE `column_type` = '02' AND `page_type` = 'news' AND `info_id` = 7458 LIMIT 1 [ RunTime:0.000236s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7458 [ RunTime:0.002422s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7662 [ RunTime:0.002350s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7588 [ RunTime:0.002320s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7510 [ RunTime:0.002263s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7490 [ RunTime:0.002308s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7429 [ RunTime:0.002196s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7380 [ RunTime:0.002222s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7378 [ RunTime:0.002237s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7374 [ RunTime:0.002301s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7373 [ RunTime:0.002210s ]
[ SQL ] SELECT * FROM `user` WHERE `id` = 203 LIMIT 1 [ RunTime:0.000224s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 466 LIMIT 1 [ RunTime:0.000229s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 466 LIMIT 1 [ RunTime:0.000222s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 458 LIMIT 1 [ RunTime:0.000176s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 458 LIMIT 1 [ RunTime:0.000163s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 209 LIMIT 1 [ RunTime:0.000173s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 209 LIMIT 1 [ RunTime:0.000170s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 372 LIMIT 1 [ RunTime:0.000155s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 372 LIMIT 1 [ RunTime:0.000161s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 521 LIMIT 1 [ RunTime:0.000172s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 521 LIMIT 1 [ RunTime:0.000168s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 819 LIMIT 1 [ RunTime:0.000169s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 819 LIMIT 1 [ RunTime:0.000164s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 385 LIMIT 1 [ RunTime:0.000176s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 385 LIMIT 1 [ RunTime:0.000155s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 657 LIMIT 1 [ RunTime:0.000154s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 657 LIMIT 1 [ RunTime:0.000155s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 412 LIMIT 1 [ RunTime:0.000166s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 412 LIMIT 1 [ RunTime:0.000156s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 274 LIMIT 1 [ RunTime:0.000157s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 274 LIMIT 1 [ RunTime:0.000159s ]

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