FDA works to avoid shortage of sitagliptin
[8/9/2022] FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus. To …
Higher limits allowed by FDA for Nitroso-sitagliptin
2022年8月10日 · The FDA said Tuesday that it recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck's type 2 diabetes drug Januvia. To …
通报 | 常用降糖药查出致癌物|缬沙坦原料药|西格列汀|致癌物|降糖 …
2022年8月14日 · 近日，FDA通过官网发布一则消息： 降糖药西格列汀的样品被检测出含有亚硝胺杂质： Nitroso-STG-19（NTTP）。 西格列汀（捷诺维）是默沙东旗下用于治疗2型 糖尿病 …
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 …
西格列汀也有亚硝胺！然而，FDA这次更怕短缺 - 药时代DrugTimes
2022年8月12日 · FDA最近发现西格列汀（2型糖尿病药物）的某些样品中含有亚硝胺杂质Nitroso-STG-19（NTTP）。为避免药品短缺并帮助确保患者获得足够的药品供应，FDA不会反对临时 …
Exploration and detection of nitrosamine impurity nitroso-STG-19 …
2024年8月1日 · The Food and Drug Administration (FDA) recently reported a new nitrosamine impurity in sitagliptin that was named nitroso-STG-19 (NTTP), whose acceptable intake limit …
FDA: Nitrosamine Impurity Detected in Diabetes Drug Sitagliptin
2022年8月10日 · Certain samples of sitagliptin have been found to contain Nitroso-STG-19 (known as NTTP), above the Food and Drug Administration’s (FDA) acceptable intake limit. …
高效液相色谱-串联三重四极杆质谱法测定西格列汀中Nitroso-STG-19…
2024年11月15日 · 摘 要： 建立高效液相色谱-串联三重四级杆质谱测定西格列汀中亚硝胺类杂质Nitroso-STG-19（NTTP）的方法。 西格列汀样品用水溶解，以乙酸乙酯为提取溶剂进行超声 …
Exploration and detection of nitrosamine impurity nitroso-STG-19 …
2024年7月25日 · " Exploration and detection of nitrosamine impurity nitroso-STG-19 in sitagliptin tablets and API as well as nitrites in excipients by LC-MS/MS methods" byHao et al. Abstract: …
N-Nitroso-STG-19 - Veeprho
N-Nitroso-STG-19 is an N-nitroso derivative of the secondary amine present in Sitagliptin, which is a highly characterized reference material that meets stringent regulatory standards set for …
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