用于Ga-68标记的PSMA-11试剂盒中活性药物PSMA-11中残留溶剂的测定

IF 0.4 4区医学 Q4 PHARMACOLOGY & PHARMACY

Acta poloniae pharmaceutica Pub Date : 2023-07-28 DOI:10.32383/appdr/168295

R. Lipka, A. Kokoszka, A. Sawicka

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引用次数: 0

摘要

建立了一种选择性、灵敏度高、低样品消耗的气相色谱法测定PSMA样品中残留溶剂的方法。在两种不同的气相色谱系统和色谱柱上获得了对制造PSMA-11所用溶剂(如乙醇、乙醚、2-丙醇、乙腈、二氯甲烷)的选择性。在所有这些情况下，获得了良好的分离和其他系统适用性参数。对乙醇、乙醚、2-丙醇(IPA)、乙腈(ACN)和二氯甲烷的检出限(LOD)和定量限(LOQ)进行了估计和实验验证。完整的验证参数，即:选择性，检出限(LOD)，定量限(LOQ)，线性，精密度，准确度，鲁棒性和系统适用性参数提供了关于ACN和IPA。在两种气相色谱系统上测定了准确度和精密度。统计测试表明，两种GC系统在准确度和精密度上没有显著差异

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DETERMINATION OF RESIDUAL SOLVENTS IN PSMA 11 - AN ACTIVE PHARMACEUTICAL SUBSTANCE IN PSMA-11 KIT FOR Ga-68 LABELLING

A selective, sensitive and low sample consumption GC method for determination of residual solvents in PSMA samples was developed. Selectivity with respect to solvents such as ethanol, diethyl ether, 2-propanole, acetonitrile, dichloromethane, used in manufacturing of PSMA-11, was obtained on two different GC systems and columns. In all these cases, good separation and other system suitability parameters were obtained. The values of detection limit (LOD) and limit of quantitation (LOQ) were estimated and verified experimentally for ethanol, diethyl ether, 2-propanol (IPA), acetonitrile (ACN) and dichloromethane. Full validation parameters i.e.: selectivity, limit of detection (LOD), limit of quantitation (LOQ), linearity, precision, accuracy, robustness and system suitability parameters are presented with respect to ACN and IPA. Accuracy and precision were measured on two GC systems. Statistical tests exhibit, that there are no significant differences in accuracy and precision between two GC systems

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来源期刊

Acta poloniae pharmaceutica 医学-药学

CiteScore

0.80

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General. A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.