FDA：伐尼克兰药品实验室分析方法
FDA：伐尼克兰药品实验室分析方法
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来源：Julia法规翻译
对于伐尼克兰中 N-亚硝基伐尼克兰杂质问题，FDA仍在调查中，已确定有些样品中该杂质超标。目前暂定限度 37 ng /天(18.5 ppm) 。
FDA发布了一份分析方法供参考。
Laboratory Analysis of Varenicline Products
FDA continues to investigate the presence of the N-nitroso-varenicline impurity in varenicline. Varenicline is a prescription drug used for smoking cessation. FDA has identified levels of N-nitroso-varenicline above FDA‘s acceptable intake limit in some samples of varenicline finished drugs.
FDA 继续调查伐尼克兰中 N-亚硝基伐尼克兰杂质的存在。伐尼克兰是一种用于戒烟的处方药。FDA 已确定某些伐尼克兰成品样品中的 N-亚硝基伐尼克兰水平高于 FDA 可接受的摄入量限值。
FDA is posting its laboratory results in the table below showing N-nitroso-varenicline levels in varenicline products currently available for the U.S. market. Testing of varenicline is still ongoing, and FDA posted its analytical method used in laboratory testing.
FDA 将其实验室结果发布在下表中，显示了目前可用于美国市场的伐尼克兰产品中的 N-亚硝基伐尼克兰水平。 伐尼克兰的测试仍在进行中，FDA 公布了其用于实验室测试的分析方法。
For reference, consuming up to the acceptable intake limit, 37 nanograms, of N-nitroso-varenicline per day is considered reasonably safe for humans, based on lifetime exposure. N-nitroso-varenicline may increase the risk of cancer if people are exposed to it above the acceptable intake limit and over a long period of time, but a person taking a drug that contains N-nitroso-varenicline at-or-below the acceptable intake limit every day for 70 years is not expected to have an increased risk of cancer. Agency scientists evaluated the risk of exposure to N-nitroso-varenicline at interim acceptable intake levels up to 185 ng per day (92.5 ppm) and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to N-nitroso-varenicline at the 37 ng per day (18.5 ppm) level.
作为参考，对人类来说， N-亚硝基伐尼克 兰 终生暴露情况下合理安全摄入水平为 37 ng/天 。 如果人们长时间接触 N-亚硝基伐尼克兰超出可接入摄入水平，可能会增加患癌症的风险，但服用含有 N-亚硝基伐尼克兰不高于可接受摄入量的药物的人预计每天摄入限制70年不会增加患癌症的风险。 该机构的科学家评估了暴露于最高 185 ng/天 (92.5 ppm) 的临时可接受摄入量下的风险，认为其不会比终生暴露于 37 ng/天 (18.5 ppm) N-亚硝基伐尼克兰带来更多癌症风险。
|
Company(Manufacturer) |
Product |
Lots Tested |
N-nitroso-varenicline level in micrograms/tablet (nanograms /tablet) |
N-nitroso-varenicline level in parts per million (ppm) |
|
公司 |
品名 |
批号 |
杂质水平 μ g/ 片（ ng/ 片） |
杂质水平 PPM |
|
Pfizer |
Chantix (varenicline) 1mg |
EA6080, EC9841, EC9847, EC9848, EX2099, DR5086 |
0.15-0.47 (150-470) |
155-474 |
|
Par Pharmaceuticals |
Varenicline 1 mg |
31960807, 31960801 |
0.003 (3) |
3 |
|
Apotex |
APO-Varenicline Tartrate 1 mg) |
TG2183, TG2181, TG2182 |
0.027-0.044 (27-44) |
27-44 |
|
Apotex |
APO-Varenicline Tartrate 0.5 mg |
TG2180, TG2178, TG2179 |
0.014-0.021 (14-21) |
27-42 |
As discussed in the July 16, 2021 CDER Statement update , Apotex is distributing Apo-Varenicline, a Canadian-approved drug product, under FDA’s temporary exercise of regulatory flexibility and discretion. Par Pharmaceutical’s varenicline product was approved by FDA on August 11, 2021.
正如 2021 年 7 月 16 日 CDER 声明更新中所讨论的那样，Apotex 的 Apo-Varenicline药物经加拿大批准，在 FDA 临时行使监管灵活性和自由裁量权的情况下，目前在美国销售。Par Pharmaceutical 的伐尼克兰产品于 2021 年 8 月 11 日获得 FDA 批准。
分析方法下载FDA链接
https://www.fda.gov/media/151470/download