| 查看: 1494 | 回复: 7 | |||
| 当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖 | |||
luwangxing金虫 (正式写手)
|
[交流]
【转帖】国产PVP遭遇FDA发难，过氧化物超标 已有5人参与
|
||
|
原文：http://www.fda.gov/drugs/drugsafety/ucm230492.htm 博爱新开源算是国内PVP较为主要的供应商吧 过氧化物超标4倍 CP05，和CP10没有检查该项目 Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients – FDA Detects High Levels of Peroxide in Crospovidone [10-21-2010] The U.S. Food and Drug Administration is alerting drug and dietary supplement manufacturers, compounding pharmacies, and distributors of Povidone analogs (Povidone/Copovidone/Crospovidone), that the agency recently detected excessive levels of peroxide in one lot of Crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by China-based Tianjin Boai NKY International Ltd1. The peroxide level found by the FDA in the lot was more than four (4) times the maximum level of peroxide (400 ppm) allowed by global compendial monographs. Other lots of Povidone analogs2 manufactured by this firm may also contain excessive levels of peroxide. An Import Alert has been issued to prevent further entry of Tianjin Boai NKY International Ltd Crospovidone into the U.S. market. To date, the FDA is not aware of any illnesses in the United States stemming from peroxide contamination. The level of peroxide found in this particular lot does not appear, on its own, to pose a significant health risk in drugs or dietary supplements. The FDA nonetheless remains concerned that elevated levels of peroxide can cause subpotent finished products. Crospovidone is a very common ingredient in drugs and dietary supplements. Peroxide is a potential impurity from the polymerization step involved in the manufacturing of Povidone analogs. Residual peroxide levels of <100 ppm have been reported to cause oxidative degradation.3 The FDA is concerned that drug manufacturers using excipients containing high levels of peroxides will observe a loss of drug potency and the formation of excessive impurities during the product shelf life. It is essential that users and distributors implement robust supplier management programs to assure that peroxide levels in Povidone analogs are in control for each batch received. Manufacturers using such excipients should employ sound risk management principles in establishing appropriate scrutiny (including peroxide testing regimen) and actions to take for a given supplier, including but not limited to the following: ( a ) review supplier history, including any relevant information on manufacturing reliability; ( b ) assess peroxide levels obtained from testing4 of past batches of Povidone analogs; ( c ) determine reliability of results reported on Certificates of Analysis; ( d ) consider information obtained from ongoing communications with suppliers; and ( e ) determine whether the quality of any finished product has been impacted. Manufacturers who use ingredients that might contain elevated levels of peroxide are advised to notify the FDA if they become aware of any further findings of quality problems or potentially related adverse events. 1 May also do business as Friends Union Enterprise (Jianjin) Ltd, Boai New Kaiyuan Pharmaceutical Company, Boai NKY Pharmaceuticals Ltd or Bluetech Chemicals Limited. 2 A recently published study also found elevated levels of peroxide in multiple lots of Povidone analogs, consistent with the FDA’s findings. (Silverstein, PhD, Irwin, Pharmaceutical Technology, Vol. 33, Issue 10, pp. 84-88, October 02, 2009. “The Case for Supplier Qualification.”) 3 Hartauer, et al, Pharm. Dev. Technol. 2000;5(3):303-10. “Influence of peroxide impurities in povidone and crospovidone on the stability of raloxifene hydrochloride in tablets: identification and control of an oxidative degradation product.” 4 A peroxide test is not currently listed in the USP monographs for crospovidone and povidone. However, a non-specific USP/EP method (see Copovidone NF) can be used to readily detect peroxide present at 400 ppm in Povidone analogs. Alternatively, a validated method shown to be specific for peroxide and having at least the same sensitivity as the compendial method may be used. For import alert information, please see: http://www.accessdata.fda.gov/cms_ia/importalert_189.html 这是我在sfda网站看到的。据我所知，巴斯夫的交联吡咯烷酮的COA中有这一项指标，标准是不大于400ppm。 |
回复此楼» 猜你喜欢
308求调剂
已经有20人回复
-
中科院总分315求调剂
已经有3人回复
-
求调剂 材料与工程 324分 专硕
已经有3人回复
-
化学工程与技术324调剂
已经有15人回复
-
一志愿矿大，材料工程专硕314分，0856可调都可以
已经有12人回复
-
环氧灌封胶 抗沉剂
已经有4人回复
-
268分085602化学工程调剂
已经有22人回复
-
考研调剂
已经有18人回复
-
还有化工二轮调剂的学校吗
已经有39人回复
-
277 数一104，学硕，求调剂
已经有8人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 转：具有全新降低血糖机制的新药被fda专家小组否定
已经有3人回复
meteord
木虫 (正式写手)
- 应助: 17 (小学生)
- 金币: 5330.2
- 散金: 68
- 红花: 1
- 帖子: 436
- 在线: 192.9小时
- 虫号: 862641
- 注册: 2009-10-04
- 性别: GG
- 专业: 药剂学
7楼2010-10-28 09:15:57
tjegg
铁杆木虫 (著名写手)
- 应助: 26 (小学生)
- 金币: 6869.3
- 红花: 16
- 帖子: 2615
- 在线: 448小时
- 虫号: 338983
- 注册: 2007-04-05
- 性别: GG
- 专业: 抗肿瘤药物药理
2楼2010-10-26 10:31:59
reallove2935
禁言 (著名写手)
★
小木虫(金币+0.5):给个红包，谢谢回帖交流
小木虫(金币+0.5):给个红包，谢谢回帖交流
|
本帖内容被屏蔽 |
3楼2010-10-26 14:03:00
tjegg
铁杆木虫 (著名写手)
- 应助: 26 (小学生)
- 金币: 6869.3
- 红花: 16
- 帖子: 2615
- 在线: 448小时
- 虫号: 338983
- 注册: 2007-04-05
- 性别: GG
- 专业: 抗肿瘤药物药理
4楼2010-10-26 15:04:13
