二甲双胍成品中硝基亚甲基二胺的污染。
-Nitrosodimethylamine Contamination in the Metformin Finished Products.
机构信息
National Medicines Institute, 30/34 Chełmska, 00-725 Warsaw, Poland.
出版信息
Molecules. 2020 Nov 13;25(22):5304. doi: 10.3390/molecules25225304.
A GC-MS/MS method with EI ionization was developed and validated to detect and quantify -nitrosodimethylamine (NDMA) and seven other nitrosamines in 105 samples of metformin tablets from 13 different manufactures. Good linearity for each compound was demonstrated over the calibration range of 0.5-9.5 ng/mL. The assay for all substances was accurate and precise. NDMA was not detected in the acquired active pharmaceutical ingredient (API); however, NDMA was detected in 64 (85.3%) and 22 (91.7%) of the finished product and prolonged finished product samples, respectively. European Medicines Agency recommends the maximum allowed limit of 0.032 ppm in the metformin products. Hence, 28 finished products and 7 pronged dosage products were found to exceed the acceptable limit of daily intake of NDMA contamination. The implications of our findings for the testing of pharmaceutical products are discussed.
建立并验证了一种 GC-MS/MS 方法，采用 EI 离子化源，用于检测和定量 105 份来自 13 家不同制造商的盐酸二甲双胍片中的 -亚硝基二甲胺（NDMA）和其他 7 种亚硝胺。 对于每个化合物，在 0.5-9.5ng/mL 的校准范围内均表现出良好的线性关系。 所有物质的测定均准确且精密。 在获得的原料药（API）中未检测到 NDMA； 然而，在成品和延长的成品样品中，分别检测到 64 个（85.3%）和 22 个（91.7%）样品中存在 NDMA。 欧洲药品管理局建议盐酸二甲双胍产品中的最大允许限量为 0.032ppm。 因此，发现 28 个成品和 7 个分剂量产品的 NDMA 污染超过了每日可接受摄入量的限值。 讨论了我们的发现对药物产品检测的影响。
Zotero 插件