药品中的亚硝酸基因毒性杂质NTTP的来源和检测方法 - 知乎
根据FDA要求，NTTP的终生暴露可接受限度（AI）为每日37ng，对应西格列汀中的控制限值为0.37ppm（370ppb），短期可接受摄入量（AI）限值不应超过246.7ng/天。
Update on nitrosamine impurity in sitagliptin products
2022年11月2日 · Sitagliptin is an oral anti-diabetic medicine that helps control blood sugar levels in patients with type 2 diabetes mellitus. Recently, a new nitrosamine impurity, Nitroso-STG-19 (also known as NTTP), has been detected in trace amounts in …
FDA works to avoid shortage of sitagliptin
To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, FDA will not object to the temporary distribution of sitagliptin containing NTTP above the...
FDA: Nitrosamine Impurity Detected in Diabetes Drug Sitagliptin
2022年8月10日 · Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor is indicated as an adjunct to diet and exercise in type 2 diabetes. The FDA has decided to allow the temporary distribution of...
西格列汀专利到期，仿制时需关注亚硝胺杂质NTTP_光谱网
4 天之前 · 默沙东研发的 西格列汀（Sitagliptin） 是第一个 DPP-4 抑制剂，可单独应用，或与其他口服降糖药组成复方药物治疗 2 型糖尿病。 其优点是安全性好，低血糖及体重增加的不良反应发生率低。 磷酸西格列汀片是进口产品独霸市场的典型代表，数据显示，其在 2023 年国内公立医院的销售额为 26.56 亿元，默沙东占据了 99.65% 的市场份额。 据了解，默沙东的磷酸西格列汀在国内的化合物专利 CN1290848C 已于 2022 年 7 月 4 日到期，但其晶型专利 CN100430397C，即 …
Recently, the FDA identified the presence of a nitrosamine impurity, nitroso-sitagliptin impurity (NTTP), in select samples of sitagliptin, raising concerns due to the potential carcinogenicity of nitrosamine compounds.
Development and Validation for Quantification of 7-Nitroso …
It is an anti-diabetic drug used in the treatment of type 2 diabetes and it belongs in the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing insulin production and decreasing the production of glucagon in the pancreas. The U.S. Food and Drug Administration (FDA) [11] approved sitagliptin in October 2006 [12].
Nitrosamine impurity detected in sitagliptin | Reactions Weekly
2022年8月20日 · The US FDA is working to avoid a shortage of sitagliptin after detection of a nitrosamine impurity, nitroso-STG-19 (NTTP). To ensure an adequate supply of sitagliptin, the FDA will not object to temporary distribution of sitagliptin with NTTP levels above the acceptable limit of 37ng per day, up to a maximum of 246.7ng per day.
N-Nitroso Sitagliptin Impurity 20-D4 - Simson Pharma Limited
Buy N-Nitroso Sitagliptin Impurity 20-D4 CAS No- NA, a high quality product from Simson Pharma Limited, a Leading Manufacturer and Exporter of N-Nitroso Sitagliptin Impurity 20-D4 accompanied by Certificate of Analysis.
UPLC-MS/MS法测定磷酸西格列汀中基因毒性杂质NTTP - fx361.cc
2024年1月11日 · 西格列汀 (结构式见图1)是一种二肽基肽酶-4 (DPP-4)抑制剂,可以刺激胰高血糖素的释放并减少胰岛素的分泌,从而发挥降糖作用,是一种常见的降糖药,可与其他药联合用药来治疗包括超重肥胖、胰岛素治疗不佳、肥胖型 2 型糖尿病等疾病,治疗效果良好 [10-12]。 2022年报道表明西格列汀合成中间体三氟甲基-5,6,7,8-四氢-1,2,4-三唑并- [4,3-α]-吡嗪盐酸盐 (TTP) [13]可能与亚硝酸盐反应生成Nitroso-STG-19 (NTTP,见图1)。 NTTP是新发现的一种存在于西格列汀中的基 …