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38:00
Basics of Analytical Testing and Validation of Analytical Method
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Q1
of 26
Score: 3.97
What is the purpose of pharmaceutical analysis?
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
of 26
Score: 3.97
What is the primary classification of analytical techniques?
Organic and Inorganic
Instrumental and non-instrumental
Qualitative and Quantitative
Spectroscopic and Electrochemical
Q3
of 26
Score: 3.97
Which of the following is NOT a type of spectroscopic method?
Conductometry
Fluorescence Spectroscopy
Ultraviolet and Visible Spectroscopy
Nuclear Magnetic Resonance (NMR)
Q4
of 26
Score: 3.97
Which of the following is NOT a type of titration?
Precipitation titration
Acid-base titration
Gravimetric titration
Redox titration
Q5
of 26
Score: 3.97
Does Titration only involve the measurement of volume?
True
False
Q6
of 26
Score: 3.97
It is a procedure to analyze and determine the percentage of the drug substances present in the product product.
Potency
Purity
Assay
Related substances
Q7
of 26
Score: 3.97
It is a procedure to measure of a drug's biological activity expressed in terms of the dose required to produce a pharmacological effect of given intensity.
Assay
Purity
Potency
Impurity
Q8
of 26
Score: 3.97
------------------ is categorized as
qualitative
,
quantitative
,
chromatographic
,
chemical, Instrumental
, and
Destructive
testing method.
pH test method
Thin layer chromatography test method
Melting point test method
HPLC test method
Q9
of 26
Score: 3.97
The selection of analytical testing methods is driven by the
The chemistry of analyte (Optical properties).
The abundance of analyte in the sample.
The intended use of method (application)
All of them
Q10
of 26
Score: 3.97
The generated specification of the ---------------------- test is in the form of a fixed numerical value
Appearance test.
Melting Point test.
Optical rotation test
pH test
Q11
of 26
Score: 3.97
Which of the following validation tests may be performed during the development of the analytical testing method?
Robustness and stability of analytical solution.
Linearity.
Precision.
Accuracy.
Q12
of 26
Score: 3.97
What should an analyst describe in an analytical procedure?
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
of 26
Score: 3.97
Which of the following is a guideline used to validate pharmaceutical methods?
USP
ICH
FDA
All of the above
Q14
of 26
Score: 3.97
What is the primary focus of specificity in analytical method validation?
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
of 26
Score: 3.97
According to the ICH guidelines, which of the following is NOT a parameter of analytical method validation?
Precision
Sensitivity
Linearity
System suitability
Q16
of 26
Score: 3.97
if a common analysis method is collaboratively studied between the Saudi laboratory and Jordanian laboratory, the precision of the testing method during the validation study should be:
Intra-assay precision.
Intermediate precision.
within-laboratories precision
Ruggedness
Q17
of 26
Score: 3.97
What is the formula to calculate the Limit of Quantitation (LOQ)?
LOQ = SD(I)/S
LOQ = 10 SD(I)/S
LOQ = 20 SD(I)/S
LOQ = 5 SD(I)/S
Q18
of 26
Score: 3.97
The Ruggedness is the ability of an analytical method to be unaffected by small changes in operating parameters.
True
False
Q19
of 26
Score: 3.97
The interference caused by the formulation excipients is a challenge in developing analytical methods for drug formulation.
True
False
Q20
of 26
Score: 3.97
What is the parameter used to evaluate the efficiency of a chromatographic system?
Tailing factor (T)
Resolution (Rs)
Capacity factor (K)
Retention time (Rt)
Q21
of 26
Score: 3.97
If the analysis method was found selective for the Assay application, the ------------ is not required to evaluate.
Limit of detection study
Stress study
Accuracy study
System suitability test
Q22
of 26
Score: 3.97
Peak purity (PP) refers to the degree of separation between two peaks in a chromatogram, a graphical representation that ensures the principal peak is not attributable to minor peaks; PP should equal or less than 0.98 in pharmaceutical analysis.
True
False
Q23
of 26
Score: 3.97
Which of the following stress conditions can be performed in Forced degradation test:
Acidic stress condition
Basic stress condition
Photocatalytic stress condition
Thermal stress condition
Oxidation stress condition
All of them
Non of them
Q24
of 26
Score: 3.97
If the correlation coefficient (R) is ---------- and the limit of detection (LOD) is ---------------, the analytical method should be linear
.
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
of 26
Score: 3.97
If the Recovery of 0.1% impurities within ---------------------------, the method should be accurate.
98% -102%
97% - 103%
95%-105%
90%-110%
Q26
of 26
Score: 0.79
تقييمك لموضوع التدريب ومناسبته لاحتياجاتك ومادة التدريب وقدرة المدرب ورغبتك في عقد دورة تدريبية بموضوع جديد مع نفس المدرب
ممتاز 91-100
جيد جدا 81-90
جيد 71-80
مقبول 61-70
ضعيف اقل من 60
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