QC1 & 2

Performance

1. Suppository that does not melt at body temperature is what kind of defect?
   A. Major
   B. Critical
   C. Minor
   D. Performance

Leaker test

2. Samples of raw materials in the quarantine area will not be subjected to this test:
   A. Physical & organoleptic examination
   B. Leaker test
   C. Potency assay
   D. Microbiological test

Quality

3. It is the sum of all factors which contributes directly or indirectly to the safety, effectiveness and acceptability of the product.
   A. Quality Assurance
   B. Quality
   C. Conformance
   D. Quality Control

All of the choices

4. Which of the following are possible sources of variation?
   A. Men
   B. Materials
   C. Method
   D. All of the choices

Deterioration

5. An impairment of the condition or quality of drug:
   A. Adulteration
   B. Deterioration
   C. Counterfeit
   D. Misbranding

All of the above

6. 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
   D. All of the above

Material inspection methods

7. The sampling and examination of all raw materials received by the factory is a function of the:
   A. Documentation section
   B. Biological testing laboratory
   C. Material inspection methods
   D. Analytical laboratory

Making sure quality policies are followed

8. Quality Assurance is concerned with:
   A. Quality monitoring and audit
   B. Making sure quality policies are followed
   C. Stability testing
   D. A and B

A and C

9. 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

Accreditation of raw material suppliers

10. 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

Environmental monitoring

11. 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

Aerosols

12. Visual appearance is essential for all, except:
    A. Aerosols
    B. Liquid preparation
    C. Tablets and Capsules
    D. Lyophilized preparations

Recall

13. 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:
    A. Recall
    B. Market withdrawal
    C. Stock recovery
    D. None of the above

Attribute chart

14. In SQC, the control chart prepared based on the number of fraction defective is called:
    A. Attribute chart
    B. Beer's plot
    C. Bar chart
    D. Variable chart

Wrong labels

15. A critical defect that would stop the packaging line operations:
    A. Wrong labels
    B. Misaligned labels
    C. Inverted labels
    D. Smeared labels

Standard deviation

16. The degree of freedom is used in the calculation of:
    A. Average
    B. Mean
    C. Range
    D. Standard deviation

Military standard

17. 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

Statistics

18. Quality can be monitored by the application of:
    A. Statistics
    B. Algebra
    C. Calculus
    D. Trigonometry

Quality Control Chart

19. A tool for detecting variations in a process is the:
    A. Pie Chart
    B. Bar Graph
    C. Quality Control Chart
    D. T-Chart

P-Chart

20. The variation of the amount of defective present can be shown in a:
    A. P-Chart
    B. X-Chart
    C. R-Chart
    D. T-Chart

Sampling

21. The process of removing an appropriate number of items from a population in order to make inferences to the entire population.
    A. Sampling B. Inspection C. Control D. Statistic

Three

22. A process is in control if the value obtained is within _____ standard deviation.
    A. Two B. Three C. Four D. Five

Random sampling

23. Sampling plan using the square root system:
    A. 100% Inspection
    B. Random sampling
    C. Military standard
    D. None of the above

4 %

25. Unacceptable quality level is considered unacceptable if it contains _____ defective tablets:
    A. 2 % B. 3 % C. 4 % D. 5 %

2 %

24. Acceptable quality level is considered acceptable if it contains _____ defective tablets:
    A. 2 % B. 3 % C. 4 % D. 5 %

Fraction defective

26. The ratio between the number of defectiveness found to the total number of units inspected in a series of batches:
    A. Average mean
    B. Fraction defective
    C. Standard deviation
    D. Range

All of the above

27. Methods of sampling plan:
    A. 100% Inspection
    B. Random sampling
    C. Military standard
    D. All of the above

All of the above

28. Military standard table is also known as:
    A. Government sampling plan
    B. MIL - STD - 105 D
    C. ABC - STD 105 D
    D. All of the above

59.5 - 60.5

29. The average fill volume was 60mL within-in-process specification of 57-63 mL, if one standard deviation is 0.5mL, calculate UCL & LCL.
    A. 58.5 - 61.5
    B. 59 - 61
    C. 59.5 - 60.5
    D. None of the choices

All of the choices

30. The term dried to constant weight means that two consecutive weighing do not differ by more than:
    A. 0.0002 g
    B. 0.2 mg
    C. 0.5 mg/g
    D. All of the choices

Desiccators

31. To keep samples moisture free, the appropriate apparatus to use is: A. Desiccators B. Separatory funnel C. Furnace D. Incubator

Gravimetric analysis

33. Analysis in which separation of the constituents from the sample is done and then weighing the product is:
    A. Volumetric analysis
    B. Instrumental method of analysis
    C. Gravimetric analysis
    D. Special method of analysis

Biological testing

32. Performs and evaluate microbiological and pharmacological assay, sterility, pyrogen, and bacteriological tests, safety or acute toxicity test.
    A. Material inspection section
    B. Analytical laboratory
    C. Biological testing
    D. Specification & analytical laboratory

A and B

34. Total Quality Management involves:
    A. Continuous improvement
    B. Defect prevention
    C. Defect detection
    D. A and B

Critical defect

35. A defect that may endanger life or property and may render the product non-functional.
    A. Ocular defect
    B. Major defect
    C. Critical defect
    D. Attribute defect

Minor defect

36. A slight deviation of the color of the label from the color of standards is an example of a:
    A. Minor defect
    B. Variable defect
    C. Major defect
    D. Performance defect

Internal defect

37. A subpotent product is a/an:
    A. Critical defect
    B. Major defect
    C. Internal defect
    D. A and B

QC

38. Include all tests and evaluations performed to ensure that quality has been achieved in a specific lot of production.
    A. QA
    B. QC
    C. TQM
    D. GMP

Accuracy

39. Describes how close a measured value is to the true value. A. Accuracy
    B. Precision
    C. Range
    D. Standard deviation

Determinate

40. Other name of systematic error.
    A. Determinate
    B. Indeterminate
    C. Random
    D. Both B and C

Robustness

41. 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:
    A. Linearity
    B. Robustness
    C. Ruggedness
    D. none of the choices

Instrumental error

42. This error is due to faulty and uncalibrated pH meter, balances, potentiometers, etc:
    A. Personal error
    B. Instrumental error
    C. Error of method
    D. Reagent error

A and C

43. 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

Precision

44. It is a measure of reproducibility of data within a series of results:
    A. Accuracy
    B. Precision
    C. Specificity
    D. Reliability

All of the choices

45. 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

Blank solution

46. Solution containing all the reagents and solvents used in the analysis, but no deliberately added analyte.
    A. Blank solution
    B. Solution with sample
    C. Standard solution
    D. Test solution

Volumetric solutions

47. Standard solutions are also known as:
    A. Test solutions
    B. Volumetric solutions
    C. Saturated solutions
    D. None of the choices

All of the choices

48. Types of chemical reaction used in the volumetric analysis. A. Redox B. Neutralization C. Diazotization D. All of the choices

None of the choices

49. 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

Edentate disodium

50. The reaction between HCl and calcium carbonate can be seen in the standardization of:
    A. Silver nitrate
    B. Ammonium thiocyanate
    C. Edentate disodium
    D. Sulfuric acid

No indictor is suggested

51. When a weak base is to be titrated with weak acid, the indicator used is:
    A. Phenolphthalein
    B. Methyl orange
    C. Methyl red
    D. No indictor is suggested

Molecular weight/no. of electrons loss

52. The formula to compute the equivalent weight of a reducing agent.
    A. Molecular weight/no. of electrons gain
    B. Molecular weight/no. of electrons loss
    C. Both A and B
    D. None of the choices

Back titration

53. Residual titration method is also known as:
    A. Direct titration
    B. Indirect titration
    C. Back titration
    D. Redox titration

g or mg/mL

54. 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

Phenolphthalein

55. The indicator used if weak acid is titrated with strong alkali. A. Methyl orange
    B. Methyl red
    C. Phenol red
    D. Phenolphthalein

Pink

56. Phenolphthalein in alkali medium is colored:
    A. Yellow
    B. Pink
    C. Colorless
    D. Blue

Residual titration

57. 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.
    A. Gravimetric analysis
    B. Acidimetric analysis
    C. Direct alkalimetric analysis
    D. Residual titration

Pharmaceutical assaying

58. An analyst who determines the strength, potency and percentage purity of a drug or pharmaceutical product is performing:
    A. Special method
    C. Pharmacopeial testing
    B. Identification tests
    D. Pharmaceutical assaying

Number of mEq

59. Two substances reacting upon reaching the end point must have the same:
    A. Normality
    B. Volume
    C. Number of mEq
    D. Weight

All of the above

60. Type of titration used in volumetric analysis:
    A. Direct
    B. Residual
    C. Indirect
    D. All of the above

A. Inspection

61. The process of measuring, examining, testing or otherwise comparing the unit of product with the requirements.
    A. Inspection
    B. Sampling
    C. Assay
    D. Statistical analysis

A and B

62. 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 and C

63. 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

Volumetric

64. The determination of the volume of a solution of known concentration required to react with a given amount of a substance to be analyzed:
    A. Gravimetric
    B. Volumetric
    C. Special method
    D. Instrumental method

Hydrochloric acid

65. Solution of sodium hydroxide or potassium hydroxide may be standardized by the use of a standard solution of _____ as a secondary standard:
    A. Hydrochloric acid
    B. Nitric acid
    C. Glacial acetic acid
    D. Formic acid

A and B

66. The standard alkali solutions commonly used are:
    A. Sodium hydroxide
    B. Potassium hydroxide
    C. Calcium hydroxide
    D. A and B

Molarity

67. The number of moles of solute per liter of solution is:
    A. Molarity
    B. Molality
    C. Normality
    D. Formality

Concentration

68. A secondary standard is a solution of known:
    A. Quality B. Purity C. Concentration D. A and B

All of the above

69. The chemical reactions which serve as the basis of titrimetric analysis:
    A. Neutralization
    B. Precipitation/Complexation
    C. Redox
    D. All of the above

Sodium carbonate

70. The primary standard used to standardize 1 N Hydrochloric acid is:
    A. Calcium carbonate
    B. Sodium carbonate
    C. Magnesium carbonate
    D. Sodium oxalate

A and C

71. Expression of concentration in volumetric solutions:
    A. Normality
    B. Titer
    C. Molarity
    D. A and C

To attain a sharp end point

72. 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

Molality

73. It is defined as the number of moles of solute per kilogram of solvent:
    A. Normality B. Molarity C. Molality D. Titer

Physiochemical theory

74. 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:
    A. Physiochemical theory
    B. Organic theory
    C. Colloidal theory
    D. None of the above

0.1004

75. 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

M=ws/ V x MW/1000

A. 0.304
B. 0.1004
C. 0.1005
D. 0.403

7.15 mg

76. What is the titer value for 0.05 M calcium chloride with 2 moles of water? MW = 142.9

Titer = 1mL x M x (MW/1000)

A. 3.37 mg
B. 7.15 mg
C. 73.5 mg
D. 53.7 mg

0.998

77. How many grams of Cupric (II) Sulfate pentahydrate should be dissolved in a volume of 500 mL to make 8 x 10^-3 M solution? MW = 249.54

ws= V x M x (MW/1000)

A. 0.998
B. 9.98
C. 99.8
D. 109.1

16.53

78. 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?

V1= M2V2/M1

A. 1.65
B. 6.53
C. 16.53
D. 165.3

B. 1.24

79. 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

M=ws/ V x MW/1000

A. 0.12
B. 1.24
C. 12.4
D. 124

67

80. The gram-equivalent weight of sodium oxalate (MW = 134 g/mole) is:
    A. 67
    B. 0.067
    C. 0.114
    D. 0.026

0.09196

81. 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

M=ws/ V x MW/1000

A. 0.09196
B. 0.91960
C. 0.21090
D. 0.01209

49

82. The molecular weight of sulfuric acid is 98. Its equivalent weight is:
    A. 98
    B. 49
    C. 0.098
    D. 0.049

30

83. 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?

Ws = V x N x mEqwt

A. 20
B. 30
C. 40
D. 60

Kjeldahl method

84. Developed in 1883, this method of analysis remains as one of the accurate and widely used method for determining nitrogen in substances.
    A. Non-aqueous titrimetry
    B. Precipitation
    C. Redox titration
    D. Kjeldahl method

Acidimetry

85. The measurement of a base of a given sample by titration of standard acid is:
    A. Acidimetry
    B. Alkalimetry
    C. Compleximetry
    D. Redox titration

Acidimetric residual

86. Assay of zinc oxide is what type of analysis?
    A. Alkalimetric residual
    B. Acidimetric direct
    C. Acidimetric residual
    D. Alkalimetric direct

Methyl red

87. In the assay of Milk of Magnesia, the indicator used is:
    A. Methylene blue
    B. Methyl orange
    C. Methyl red
    D. Phenolphthalein

29%

88. 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/wHCl. MW = 36.45

%w/w= V x N x mEqwt / ws x 100

A. 29%
B. 1%
C. 92%
D. 69%

10%

89. 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

%w/w= v x N x mEqwt /ws x 100

A. 10%
B. 20%
C. 30%
D. 40%

15.1

90. 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

A. 3.86
B. 15.1
C. 51.5
D. 5.65

Both A and B

91. Complete the reaction: H2C4H4O6 + NaOH

A. Na2C4H4O6
B. H2O
C. Both A and B
D. None of the choices

Phenolphthalein TS

92. Most suitable indicator to use in the titration of organic acids:
    A. Methyl red TS
    B. Methyl Orange TS
    C. Phenolphthalein TS
    D. All of the choices

Acetic acid + salicylic acid

93. Hydrolysis products of ASA.
    A. Acetic acid + sodium hydroxide
    B. Acetic acid + salicylic acid
    C. Salicylic acid + sodium hydroxide
    D. Sodium salicylate + water

Residual alkalimetry

94. Assay of ASA (raw material) is an example of what method of analysis?
    A. Direct alkalimety
    B. Residual alkalimetry
    C. Direct acidimetry
    D. Residual acidimetry

Methyl red

95. The indicator of choice for inorganic acid:
    A. Methyl orange
    B. Methyl red
    C. Crystal violet
    D. Bromocresol green

Phenolphthalein

96. The indicator used in the assay of Aspirin:
    A. Methyl red
    B. Phenolphthalein
    C. Methyl orange
    D. Phenol red

A and B

97. Blank titration are necessary to:
    A. Correct for the action of the reagent with the titrant
    B. Eliminate errors from different sources
    C. A and B
    D. None of the above

0.14896

98. What weight of arsenic trioxide (98.73%) would be used as a sample so that 26.6 mL of 0.1120 N Iodine would be needed to titrate it? MW = 197.46

Ws = V x N x mEqwt

A. 0.14896
B. 0.4896 g
C. 0.1111 g
D. 0.9145 g

Potassium hydrogen phthalate

99. Primary standard in the standardization of perchloric acid. A. Potassium hydrogen phthalate
    B. Calcium carbonate
    C. Benzoic acid
    D. Sodium carbonate

Benzoic acid

100. Primary standard in the standardization of sodium methoxide.
     A. Benzoic acid
     B. Sodium bicarbonate
     C. Sodium carbonate
     D. Potassium hydrogen phthalate