第六章测试
1.Pharmaceutical analysis means( )?
A:定量分析 B:质量分析 C:定性分析 D:药物分析
答案:D
2.Which of the following techniques are used to separate trace impurities? ( )
A:Gas chromatography (GC) B:thin layer chromatography (TLC) C:solvent extraction D:high pressure liquid chromatography (HPLC) 3.Which of the following techniques are used for identification of unknown products? ( )
A:nuclear magnetic resonance spectroscopy (NMR) B:infrared spectroscopy (IR) C:mass spectroscopy (MS) D:Elemental analysis 4.In order to detect small changes reliably with a limited number of replicate assays at each time point, the analysis must be( )?
A:free of interference from the degradation products B:very precise C:free of “drift” due to changes in instruments, standards, operators D:no special requirement 5.The preferred solution to the problem of quantitative control assays is to use HPLC or GC methods which afford ( ).
A:good specificity B:simplicity C:excellent precision and accuracy D:high speed 6. Stability studies are especially demanding of analytical precision and accuracy because changes of a few percent over a period of 3 to 5 years are significant and must be accurately quantitatted.( )
A:错 B:对 7.The procedures used during product development can not be simplified.( )
A:对 B:错 8.Control limits on both the purity of the drug substance and the drug content of the finished formulation are usually very tight, thus requiring very precise quantitative procedures for testing compliance. ( )
A:对 B:错 9.This separation is frequently accomplished by extraction, solvent partitioning, filtration, or column chromatography, but many other techniques find occasional application.( )
A:对 B:错 10.A reference standard is required whenever a relative technique such as GC, HPLC, ultraviolet, visible or infrared spectrophotometry, fluorometry, or polarography is used for the analysis.( )
A:错 B:对 11.The purity value of the standard must be derived from absolute methods. ( )
A:错 B:对

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