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WorksheetsQuality Control (Part 1)
Total questions: 100
Worksheet time: 2hrs 40mins
Suppository that does not melt at body temperature is what kind of defect?
Major
Critical
Minor
Performance
Samples of raw materials in the quarantine area will not be subjected to this test:
Physical & organoleptic examination
Leaker test
Potency assay
Microbiological test
It is the sum of all factors which contribute directly or indirectly to the safety, effectiveness and acceptability of the product.
Quality Assurance
Quality
Conformance
Quality Control
Which of the following are possible sources of variation?
Men
Materials
Method
AOTA
An impairment of the condition or quality of drug:
Adulteration
Deterioration
Counterfeit
Misbranding
Drug recall:
A. Is a function of the regulatory agency
B. Should be filed by a dissatisfied customer
C. Damages the reputation of the company
AOTA
The sampling and examination of all raw materials received by the factory is a function of the:
Documentation section
Biological testing laboratory
Material inspection methods
Analytical laboratory
Quality Assurance is concerned with:
A. Quality monitoring and audit
B. Making sure quality policies are followed
C. Stability testing
A and B
What physical test(s) can be used as an identity check for raw materials?
A. Melting point
B. Color
C. Specific gravity
D. A and C
The following are duties of the quality control department, except:
A. Establishment of written sampling plan
B. Taking part in the validation program
C. Audit
D. Accreditation of raw material suppliers
Exposure of bacterial plates in the production areas to determine the microbiological load of each room is called:
A. Environmental monitoring
B. Pollution monitoring
C. Sterility testing
D. Validation
Visual appearance is essential for all, except:
Aerosols
Liquid preparation
Tablets and Capsules
Lyophilized preparations
The company’s removal or correction of a marketed product that the regulatory agency consider to be in violation of the laws and against which the agency would initiate legal action:
Recall
Market withdrawal
Stock recovery
NOTA
In SQC, the control chart prepared based on the number of fraction defective is called:
Attribute chart
Beer’s plot
Bar chart
Variable chart
A critical defect that would stop the packaging line operations:
Wrong labels
Misaligned labels
Inverted labels
Smeared labels
The degree of freedom is used in the calculation of:
Average
Mean
Range
Standard deviation
A common sampling plan using master tables to interpret results is:
A. 100% Inspection
B. Square root system
C. Military standard
D. A and C
Quality can be monitored by the application of:
Algebra
Statistics
Calculus
Trigonometry
A tool for detecting variations in a process is the:
Pie Chart
Bar Graph
Quality Control Chart
T-Chart
The variation of the amount of defective present can be shown in a:
P-Chart
X-Chart
R-Chart
T-Chart
The process of removing an appropriate number of items from a population in order to make inferences to the entire population
Sampling
Inspection
Control
Statistic
A process is in control if the value obtained is within _____ standard deviation.
Two
Three
Four
Five
Sampling plan using the square root system:
100% Inspection
Random sampling
Military standard
None of the above
Acceptable quality level is considered acceptable if it contains _____ defective tablets:
2 %
3 %
4 %
5 %
Unacceptable quality level is considered unacceptable if it contains _____ defective tablets:
2 %
3 %
4 %
5 %
The ratio between the number of defectiveness found to the total number of units inspected in a series of batches:
Average mean
Fraction defective
Standard deviation
Range
Methods of sampling plan:
100% Inspection
Random sampling
Military standard
AOTA
Military standard table is also known as:
Government sampling plan
MIL – STD – 105 D
ABC – STD 105 D
AOTA
The average fill volume was 60mL within-in-process specification of 57-63 mL, if one standard deviation is 0.5mL, calculate UCL & LCL.
58.5 – 61.5
59 – 61
59.5 – 60.5
NOTA
The term dried to constant weight means that two consecutive weighing do not differ by more than:
0.0002 g
0.2 mg
0.5 mg/g
AOTA
To keep samples moisture free, the appropriate apparatus to use is:
Desiccators
Separatory funnel
Furnace
Incubator
Performs and evaluate microbiological and pharmacological assay, sterility, pyrogen, and bacteriological tests, safety or acute toxicity test.
Material inspection section
Analytical laboratory
Biological testing
Specification & analytical laboratory
Analysis in which separation of the constituents from the sample is done and then weighing the product is:
Volumetric analysis
Instrumental method of analysis
Gravimetric analysis
Special method of analysis
Total Quality Management involves:
A. Continuous improvement
B. Defect prevention
C. Defect detection
A and B
A defect that may endanger life or property and may render the product non-functional.
Ocular
Major
Critical
Attribute
A slight deviation of the color of the label from the color of standards is an example of a:
Minor
Variable
Major
Performance
A sub-potent product is a/an:
A. Critical
B. Major
C. Internal
D. A and B
Include all tests and evaluations performed to ensure that quality has been achieved in a specific lot of production.
QA
QC
TQM
GMP
Describes how close a measured value is to the true value.
Accuracy
Precision
Range
Standard deviation
Other name of systematic error.
Determinate
Indeterminate
Random
NOTA
In analytical methods, the measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage is called:
Linearity
Robustness
Ruggedness
NOTA
This error is due to faulty and uncalibrated pH meter, balances, potentiometers, etc:
Personal
Instrumental
Error of method
Reagent error
This error manifest by slight variation in a series of observation made by the same observer under identical conditions:
A. Indeterminate error
B. Determinate error
C. Random error
D. A and C
It is a measure of reproducibility of data within a series of results:
Accuracy
Precision
Specificity
Reliability
Reasons why residual titration are performed.
A. Reaction proceeds slowly
B. Poor solubility of the sample
C. Sample does not give sharp end point
D. All of the choices
Solution containing all the reagents and solvents used in the analysis, but no deliberately added analyte.
Blank solution
Solution with sample
Standard solution
Test solution
Standard solutions are also known as:
Test solutions
Volumetric solutions
Saturated solutions
None of the choices
Types of chemical reaction used in the volumetric analysis.
Redox
Neutralization
Diazotization
AOTA
HCl + Calcium carbonate will react to form a primary product known as:
A. Carbonic acid
B. Calcium hydroxide
C. Both A and B
D. None of the choices
The reaction between HCl and calcium carbonate can be seen in the standardization of:
Silver nitrate
Ammonium thiocyanate
Edentate disodium
Sulfuric acid
When a weak base is to be titrated with weak acid, the indicator used is:
Phenolphthalein
Methyl orange
Methyl red
No indictor is suggested
The formula to compute the equivalent weight of a reducing agent.
Molecular weight/no. of electrons gain
Molecular weight/no. of electrons loss
Both A and B
NOTA
Residual titration method is also known as:
Direct titration
Indirect titration
Back titration
Redox titration
Titer is an expression of concentration in terms of:
A. g of solute/100 mL
B. g or mg/mL
C. g of solute/L
D. B and C
The indicator used if weak acid is titrated with strong alkali.
Methyl orange
Methyl red
Phenol red
Phenolphthalein
Phenolphthalein in alkali medium is colored:
Yellow
Pink
Colorless
Blue
This analysis is done by dissolving the substance under examination in an accurately measured quantity of standard solution known to be in excess and back titrating the excess solution with another standard solution
Gravimetric
Acidimetric
Direct alkalimetric
Residual
An analyst who determines the strength, potency and percentage purity of a drug or pharmaceutical product is performing:
Special method
Identification tests
Pharmacopeial testing
Pharmaceutical assaying
Two substances reacting upon reaching the end point must have the same:
Normality
Volume
Number of mEq
Weight
Type of titration used in volumetric analysis:
Direct
Residual
Indirect
AOTA
The process of measuring, examining, testing or otherwise comparing the unit of product with the requirements
Inspection
Sampling
Assay
Statistical analysis
The volumetric method of titration, the chemical substance being analyzed is referred to as:
A. Analyte
B. Active constituent
C. Inactive constituent
D. A and B
A chemical which changes color at or very near the end point of titration where equivalent quantities of analyte and titrant have reacted:
A. Methyl orange
B. Chloroform
C. Starch T.S.
D. A and C
The determination of the volume of a solution of known concentration required to react with a given amount of a substance to be analyzed:
Gravimetric
Volumetric
Special method
Instrumental method
Solution of sodium hydroxide or potassium hydroxide may be standardized by the use of a standard solution of _____ as a secondary standard:
Hydrochloric acid
Nitric acid
Glacial acetic acid
Formic acid
The standard alkali solutions commonly used are:
A. Sodium hydroxide
B. Potassium hydroxide
C. Calcium hydroxide
D. A and B
The number of moles of solute per liter of solution is:
Molarity
Molality
Normality
Formality
A secondary standard is a solution of known:
Quality
Purity
Concentration
NOTA
The chemical reactions which serve as the basis of titrimetric analysis:
Neutralization
Precipitation/Complexation
Redox
AOTA
The primary standard used to standardize 1 N Hydrochloric acid is:
Calcium carbonate
Sodium carbonate
Magnesium carbonate
Sodium oxalate
Expression of concentration in volumetric solutions:
A. Normality
B. Titer
C. Molarity
D. A and C
The purpose of using a combination indicators is:
A. To attain a sharp end point
B. To facilitate reaction
C. To attain a complete reaction
D. None of the above
It is defined as the number of moles of solute per kilogram of solvent:
Normality
Molarity
Molality
Titer
It attributes the color change to certain ions an increase of which causes the appearance of new color, and a decrease in which causes the disappearance of a color:
Physiochemical theory
Organic theory
Colloidal theory
NOTA
Sulfamic acid (H2NSO3) is a primary standard that can be used to standardize sodium hydroxide. What is the molarity if 34.26 mL reacts with 0.3337 g of sulfamic acid. MW=97
0.304
0.1004
0.1005
0.403
What is the titer value for 0.05 M calcium chloride with 2 moles of water? MW = 142.9
3.37 mg
7.15 mg
73.5 mg
53.7 mg
How many grams of Cupric (II) Sulfate pentahydrate should be dissolved in a volume of 500 mL to make 8 x 103 M solution? MW = 249.54
0.998
9.98
99.8
109.1
The molarity of concentrated HCl purchased in the laboratory is approximately 12.1 M. How many mL of this reagent should be diluted to 2 L to make 0.1 M?
1.65
6.53
16.53
165.3
A solution with a final volume of 500 mL was prepared by dissolving 25 mL of methanol (density=0.7914g/mL) in chloroform. Calculate the molarity of methanol in the solution. MW= 32
0.12
1.24
12.4
124
The gram-equivalent weight of sodium oxalate (MW = 134 g/mole) is:
67
0.067
0.114
0.026
Calculate the molarity of Sodium nitrite volumetric solution, if 31.6 mL of this solution reacts with 0.5004 g of Sulfanilamide (C6H8N2O2S) to reach an end point. MW of sulfanilamide=172.2
0.09196
0.91960
0.21090
0.01209
The molecular weight of sulfuric acid is 98. Its equivalent weight is:
98
49
0.098
0.049
The molecular weight of NaOH is 40. How many grams of sodium hydroxide pellets are needed to make 500 mL of 1.5 N solution?
20
30
40
60
Developed in 1883, this method of analysis remains as one of the accurate and widely used method for determining nitrogen in substances.
Non-aqueous titrimetry
Precipitation
Redox titration
Kjeldahl method
The measurement of a base of a given sample by titration of standard acid is:
Acidimetry
Alkalimetry
Compleximetry
Redox titration
Assay of zinc oxide is what type of analysis?
Alkalimetric residual
Acidimetric direct
Acidimetric residual
Alkalimetric direct
In the assay of Milk of Magnesia, the indicator used is:
Methylene blue
Methyl orange
Methyl red
Phenolphthalein
A 4.59 mL sample of HCl, specific gravity 1.3, required 50.5 mL of 0.9544 N NaOH in a titration. Calculate the %w/w HCl. MW = 36.45
29%
1%
92%
69%
A 10 mL sample of sulfuric acid solution required 16.85 mL of NaOH solution in a titration. Each mL of the NaOH solution was equivalent to 0.2477 g of potassium hydrogen phthalate. Calculate the sulfuric acid content in %w/w. MW = 98
10%
20%
30%
40%
The Kjeldahl procedure was used to analyze 256 uL of a solution containing 37.9 mg protein/mL. The liberated ammonia was collected in 5 mL of 0.0336 M HCl, and the remaining acid required 6.34 mL of 0.010 M NaOH for complete titration. What is the weight % of nitrogen in the protein? MW = 14
3.86
15.1
51.5
5.65
Complete the reaction: H2C4H4O6 + NaOH
Na2C4H4O6
H2O
Both
NOTA
Most suitable indicator to use in the titration of organic acids:
Methyl red TS
Methyl Orange TS
Phenolphthalein TS
AOTA
Hydrolysis products of ASA.
Acetic acid + sodium hydroxide
Acetic acid + salicylic acid
Salicylic acid + sodium hydroxide
Sodium salicylate + water
Assay of ASA (raw material) is an example of what method of analysis?
Direct alkalimety
Residual alkalimetry
Direct acidimetry
Residual acidimetry
The indicator of choice for inorganic acid:
Methyl orange
Methyl red
Crystal violet
Bromocresol green
The indicator used in the assay of Aspirin:
Methyl red
Phenolphthalein
Methyl orange
Phenol red
Blank titration are necessary to:
Correct for the action of the reagent with the titrant
Eliminate errors from different sources
BOTH
NOTA
What weight of arsenic trioxide (98.73%) would be used as a sample so that 26.6 mL of 0.1120N Iodine would be needed to titrate it? MW = 197.46
0.14896
0.4896 g
0.1111 g
0.9145 g
Primary standard in the standardization of perchloric acid.
Potassium hydrogen phthalate
Calcium carbonate
Benzoic acid
Sodium carbonate
Primary standard in the standardization of sodium methoxide.
Benzoic acid
Sodium bicarbonate
Sodium carbonate
Potassium hydrogen phthalate
