A DIRECT SOLID SAMPLE ANALYTICAL TECHNOLOGY FOR THE DETERMINATION OF CHELATING LIGANDS CONTAIN SULFUR AND THEIR UNIFORMITY IN COLD KIT WHICH ARE UTILIZED TO FORM STABLE COMPLEXES WITH RADIOTECHNETIUM (Tc-99m) AND RADIORHENIUM (Re-186, Re-188)
LIU, KUNG TIEN,刘公典,劉公典,CHAO, MING YU,赵明煜,趙明煜,HSIA, YI CHIH,夏仪芝,夏儀芝,YEH, SHIH WOEI,叶士纬,葉士緯,LIAO, MEI HSIU,廖美秀,廖美秀,MEN, LEE CHUNG,门立中,門立中,SHEN, LIE HANG,沈立汉,沈立漢
申请号：
TW099135930
公开号：
TWI486617B
申请日:
2010.10.21
申请国别(地区):
TW
年份:
2015
代理人:
摘要：
A direct solid sample analytical technology for determining the chelating ligands contain sulfur, i. e. active pharmaceutical ingredient (API) and their uniformity in cold kit which are utilized to form stable complexes with radiotechnetium (Tc-99m) and radiorhenium (Re-186,Re-188) is disclosed. The technology uses an elemental analyzer coupled with a non-dispersive infrared detector, a thermal conductivity detector or an isotope ratio mass spectrometer to analyze sulfur in the solid sample of cold kit. An economical, stable and commercial available reference material, i. e. coal, is employed to construct the calibration curve of sulfur. The amount of chelating ligands and their uniformity in cold kit is obtained by converting from the sulfur weight percentage in the whole kit, and is used for the quality control of API in key production processes and clinical applications.一種測定對鎝(Tc-99m)與錸(Re-186、Re-188)具有穩定錯合力之含硫螯合劑在凍晶劑中之含量與均一性的固態樣品分析技術,本技術使用元素分析儀結合紅外線偵測器、熱導偵測器或質譜儀,直接分析固態凍晶樣品,並利用價格低廉、穩定性高、容易取得之煤標準品作為對照物質來製作硫的校正曲線,將偵測結果內插到由煤對照物質製作之校正曲線,可以得到固態凍晶劑樣品中的硫含量。再進一步以重量含量百分比換算得知凍晶劑中螯合劑含量與均一性,以確保關鍵製程與臨床使用時,含硫螯合劑活性成分在凍晶劑中的藥品品質。0...含硫螯合劑在凍晶劑中的含量與均一性固態樣品分析技術1...樣品製備程序10...對照物質製備程序100...製備對照物質101...製備試車樣品102...製備校正曲線樣品103...製備查核樣品11...凍晶劑試驗物質製備程序110...製備凍晶劑試驗物質空白樣品111...製備待測樣品且該待測樣品係為含硫螯合劑2...元素分析設備分析程序20...元素分析設備系統適用性測試201...系統背景測試202...試車樣品測試21...元素分析設備凍晶劑試驗物質空白樣品基質背景值分析22...元素分析設備對照物質分析23...元素分析設備查核樣品分析24...元素分析設備待測樣品分析3...對照物質與查核樣品之硫含量計算30...計算對照物質之線性迴歸公式及相關係數300...計算對照物質硫含量301...製作校正曲線302...計算線性迴歸公式及相關係數31...計算查核樣品之準確度與回收率310...計算查核樣品硫含量之理論值311...計算查核樣品硫含量之實驗值312...計算回收率4...待測樣品之硫含量計算與含硫螯合劑含量換算40...計算試驗物質中硫含量41...計算試驗物質中螯合劑含量
