Basics of Analytical Testing and Validation of Analytical Method
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Q1           Score:  3.97
 To identify contaminants in food products
 To elucidate the structure of compounds in pharmaceutical products
 To determine chemical compounds for plant growth regulation
 To separate and purify veterinary biologics
Q2           Score:  3.97
 Organic and Inorganic
 Instrumental and non-instrumental
 Qualitative and Quantitative
 Spectroscopic and Electrochemical
Q3           Score:  3.97
 Conductometry
  Fluorescence Spectroscopy
 Ultraviolet and Visible Spectroscopy
 Nuclear Magnetic Resonance (NMR)
Q4           Score:  3.97
 Precipitation titration
 Acid-base titration
 Gravimetric titration
 Redox titration
Q5           Score:  3.97
 True
 False
Q6           Score:  3.97
 Potency
 Purity
 Assay
 Related substances
Q7           Score:  3.97
 Assay
 Purity
 Potency
 Impurity
Q8           Score:  3.97
 pH test method
 Thin layer chromatography test method
 Melting point test method
 HPLC test method
Q9           Score:  3.97
 The chemistry of analyte (Optical properties).
 The abundance of analyte in the sample.
 The intended use of method (application)
 All of them
Q10           Score:  3.97
 Appearance test.
 Melting Point test.
 Optical rotation test
 pH test
Q11           Score:  3.97
 Robustness and stability of analytical solution.
 Linearity.
 Precision.
 Accuracy.
Q12           Score:  3.97
 Only the operating parameters and reagents used
 Only the apparatus and equipment used
 Aspects that require special attention
 Only the principle and scope of the test
Q13           Score:  3.97
 USP
 ICH
  FDA
 All of the above
Q14           Score:  3.97
 Accuracy of the analytical results
 Ability to detect impurities
 Robustness of the analytical procedure
 Ability to assess unequivocally the analyte in the presence of other compounds
Q15           Score:  3.97
 Precision
  Sensitivity
 Linearity
 System suitability
Q16           Score:  3.97
 Intra-assay precision.
 Intermediate precision.
 within-laboratories precision
 Ruggedness
Q17           Score:  3.97
 LOQ = SD(I)/S
 LOQ = 10 SD(I)/S
 LOQ = 20 SD(I)/S
  LOQ = 5 SD(I)/S
Q18           Score:  3.97
 True
 False
Q19           Score:  3.97
 True
 False
Q20           Score:  3.97
 Tailing factor (T)
  Resolution (Rs)
 Capacity factor (K)
 Retention time (Rt)
Q21           Score:  3.97
 Limit of detection study
 Stress study
 Accuracy study
 System suitability test
Q22           Score:  3.97
 True
 False
Q23           Score:  3.97
 Acidic stress condition
 Basic stress condition
 Photocatalytic stress condition
 Thermal stress condition
 Oxidation stress condition
 All of them
 Non of them
Q24           Score:  3.97
 R > 0.98 and LOD < reporting limit
 R < 0.98 and LOD > reporting limit
 R = 0.98 and LOD = reporting limit
 R = 1.0 and LOD < 1%
Q25           Score:  3.97
 98% -102%
 97% - 103%
 95%-105%
 90%-110%
Q26           Score:  0.79
  ممتاز 91-100
 جيد جدا 81-90
 جيد 71-80
 مقبول 61-70
 ضعيف اقل من 60


   



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