Source来源:
FDAnews: Drug Daily Bulletin
FDA新闻：药品每日公告
Aug. 11, 2008 | Vol. 5 No. 156
2008年8月11日| 第五卷 第156号
USP Reminds Levothyroxine Makers of Updated Monograph
USP提醒左甲状腺素钠生产商关注最新各论修订
The U.S. Pharmacopeia (USP) is urging manufacturers outside the U.S. to adopt a new monograph for levothyroxine sodium, which tightens potency specifications.
美国药典委员会（USP） 敦促美国之外的生产商接受新的左甲状腺素钠各论, 其中加严了含量质量标准。
USP released the new monograph in January after the FDA announced the new specification. The requirement, which takes effect October 2009, specifies that the product’s potency be 95 percent to 105 percent throughout its shelf life. The potency range was tightened from a specification of 90 percent to 110 percent.
在FDA颁布新标准之后, USP于今年一月份发布了新的各论。 新要求将在2009年10月生效, 在货架期的含量要求由原来的90-110%加严至95-105%。
The FDA revised the specification last year after evaluating stability data from all levothyroxine sodium products. It found variable stability profiles and shelf lives for different versions of the drug, a concern for patients who use the thyroid replacement therapy and may get prescription refills made by different manufacturers with different potencies.
去年, FDA在评估了所有左甲状腺素钠产品的稳定性数据后修订了质量标准。发现对药品不同形式有不同的稳定性曲线和有效期, 由此产生了对于采用甲状腺替代疗法的病人可能得到因不同厂家生产产品的含量不同导致的处方变化的担忧。
Although the new specification is well known by firms marketing in the U.S., firms producing levothyroxine sodium products to USP specifications in other countries may not be prepared for the new standard, Karen Russo, director of small molecules and monograph acquisition at USP, said.
USP小分子物质和各论事务总监Karen Russo认为，尽管在美国的左甲状腺素钠生产厂家已经熟知这一新的标准, 但美国之外的厂家可能还没有对新标准做出相应准备。
这么多甲状腺切除术后患者，需长期服用左甲状腺素钠，严密关注中。
左甲状腺素钠
FDAnews: Drug Daily Bulletin
FDA新闻：药品每日公告
Aug. 11, 2008 | Vol. 5 No. 156
2008年8月11日| 第五卷 第156号
USP Reminds Levothyroxine Makers of Updated Monograph
USP提醒左甲状腺素钠生产商关注最新各论修订
The U.S. Pharmacopeia (USP) is urging manufacturers outside the U.S. to adopt a new monograph for levothyroxine sodium, which tightens potency specifications.
美国药典委员会（USP） 敦促美国之外的生产商接受新的左甲状腺素钠各论, 其中加严了含量质量标准。
USP released the new monograph in January after the FDA announced the new specification. The requirement, which takes effect October 2009, specifies that the product’s potency be 95 percent to 105 percent throughout its shelf life. The potency range was tightened from a specification of 90 percent to 110 percent.
在FDA颁布新标准之后, USP于今年一月份发布了新的各论。 新要求将在2009年10月生效, 在货架期的含量要求由原来的90-110%加严至95-105%。
The FDA revised the specification last year after evaluating stability data from all levothyroxine sodium products. It found variable stability profiles and shelf lives for different versions of the drug, a concern for patients who use the thyroid replacement therapy and may get prescription refills made by different manufacturers with different potencies.
去年, FDA在评估了所有左甲状腺素钠产品的稳定性数据后修订了质量标准。发现对药品不同形式有不同的稳定性曲线和有效期, 由此产生了对于采用甲状腺替代疗法的病人可能得到因不同厂家生产产品的含量不同导致的处方变化的担忧。
Although the new specification is well known by firms marketing in the U.S., firms producing levothyroxine sodium products to USP specifications in other countries may not be prepared for the new standard, Karen Russo, director of small molecules and monograph acquisition at USP, said.
USP小分子物质和各论事务总监Karen Russo认为，尽管在美国的左甲状腺素钠生产厂家已经熟知这一新的标准, 但美国之外的厂家可能还没有对新标准做出相应准备。
这么多甲状腺切除术后患者，需长期服用左甲状腺素钠，严密关注中。
左甲状腺素钠