Module 6: Quality Control and Assurance - Practice Questions - Manor

1. Most of the official drugs containing calcium and zinc are assayed by:

A) EDTA method

B) Gravimetry

C) Nonaqueous titrimetry

D) Acidimetry

A

2. Type of alkaloidal assay where the total alkaloids are determined:

A) Ultimate

B) Specific

C) Extraction

D) Proximate

D

3. Limulus ameobocyte lysate (LAL) assay method is applicable in the determination of:

A) Pyrogens

B) Chemical impurities

C) Microorganisms

D) All of the above

A

4. The measurement of a base of a given sample by titration with a standard acid is:

A) Acidimetry

B) Compleximetry

C) Alkalimetry

D) Redox

A

5. The following compounds are assayed by acidimetrically, except:

A) Sodium hydroxide

B) Caffeine

C) Citric acid

D) Zinc oxide

C

6. Which of the following substances is assayed by residual alkalimetric analysis?

A) Aspirin

B) Sodium hydroxide

C) Hydrochloric acid

D) Zinc oxide

A

7. A common sampling plan that uses master tables to interpret the results:

A) 100% inspection

B) Square root system

C) Military standard

D) A and C

C

8. Materials to be sampled include the following, except:

A) Final products

B) Records

C) Intermediate products

D) Raw materials

B

9. The process of removing an appropriate number of items from a population in order to make interferences to the entire population is called:

A) Sampling

B) Inspection

C) Statistic

D) None of the above

A

10. A tool for detecting variations in a process:

A) Pie chart

B) Bar chart

C) Quality control chart

D) T-chart

C

11. The Quality Control Department is important to:

A)Ensure uniform production of high quality product

B)Safeguard public health

C)Ensure that minimum standards of the product comply with the BFAD requirements

D) All of the above

D

12. The functions of Quality Control include the following, except:

A) Analytical control

B) Inspection control

C) Auditing

D) A and B

C

13. The QC manager is in charge of the following sections, except:

A) Specification and assay development

B) Analytical testing laboratory

C) Research and development studies

D) Biological testing

A

14. The First-In First-Out Policy must always be observed to:

A)Assures that the oldest stock is used first

B)Prevents contamination and mix-ups of materials

C)Contains the information regarding the activity of the active ingredient

D)All of the above

A

15. The Kjeldahl method of analysis is used to determine:

A) Fats

B) Sugars

C) Nitrogen

D) Oxygen in organic compounds

C

16. The ash content of an organic compound is an impurity of:

A) Carbon

B) Oil

C) Inorganic matter

D) Volatile component

C

17. The iodine value of oils is a quantitative measure of:

A) Phenol content

B) Saturated fatty acids

C) Unsaponifiable matter

D) Unsaturated fatty acids

D

18. Analysis wherein the constituents of a sample are separated and then the product is weighed:

A) Volumetric

B) Gravimetric

C) Special method

D) Gasometric

B

19. The number of mg of KOH needed to neutralize the free acids and saponify the esters in 1g of oil or fat:

A) Acid value

B) Ester value

C) Saponification value

D) Iodine value

C

20. The molecular weight of NaOH is 40. How many grams of NaOH pellets are needed to make 500mL of 1.5N solution?

A) 20

B) 30

C) 40

D) 60

B

21. If 1mL of HCl is equivalent to 1.5mL of 0.5N NaOH, the volume of the alkali that would be consumed by 30mL of acid is:

A) 4.5mL

B) 45mL

C) 20mL

D) 30mL

B

22. The most effective chemical substance in removing stains of potassium permanganate:

A) Oxalic acid

B) Sodium thiosulfate

C) Chalk

D) Vinegar

A

23. The ester value determination of substances is applicable to the following, except:

A) Fats

B) Volatile oils

C) Alcohols

D) Fatty oils

C

24. The following are indicators used for acid-base titrations, except:

A) Methyl orange

B) Phenolphthalein

C) Ferric alum

D) Methyl red

C

25. An accurately measured sample of hydrogen peroxide 2g was dissolved in a mixture of 20mL water and 20mL diluted sulfuric acid and was titrated with 0.1N potassium permanganate consuming 30mL to reach the endpoint. Compute for the percentage of hydrogen peroxide (MW=34):

A) 2.55%

B) 5.1%

C) 2.5%

D) 5.5%

A

26. Residual method titration with EDTA is applicable to what metal ion:

A) Calcium

B) Aluminum

C) Zinc

D) Magnesium

B

27. Chemical reactions that involves a change in the valence number of reacting substances:

A) Neutralization

B) Complexation

C) Oxidation-reduction

D) Precipitation

C

28. A process wherein the sample is made to liberate iodine, which is then titrated with a standard solution of sodium thiosulfate:

A) Volumetric titration

B) Back titration

C) Iodometry

D) Iodimetry

C

29. A buret with a glass stopcock can be used for:

A) Alcohols B) Acids C) Bases D) Salt

A

30. Malic acid present in cherry juice may be determined by:

A) Indirect permanganate oxidation method

B) Direct permanganate oxidation method

C) Alkalimetry

D) Acidimetry

A

31. Iodometry is an indirect analysis of:

A) Oxidizing agents B) Reducing agents C) Acids D) Bases

A

32. The unsaponified matter present in animal fat is:

A) Cholesterol B) Phytosterol C) Lard D) Wax

A

33. The bisulfite method is used in the assay of volatile oils to determine:

A) Aldehyde content B) Acid content C) Ester content D) Sulfur content

A

34. The crude fiber of a drug usually consist of:

A) Cellulose B) Cholesterol C) Phytosterol D) None of the above

A

35. In phenol content determination of a volatile oil, the layer in the graduated neck of the Cassia flask reached 2.7mL obtained from a sample of 10mL after treatment with KOH solution. The percentage of oil is:

A) 73% B) 69% C) 7.3% D) 27%

A

36. This determines the shelf life of a product:

A) Sampling inspection program

B) All of the answers

C) Validation program

D) Stability testing program

D

37. Amount of dissolved drug can be determined by:

A) Analytical balance B) Dissolution tester C) Brookefield viscometer D) DOP spray

B

38. Trace minerals in a multivitamin preparation can be assayed faster by:

A) Atomic Absorption Spectrophotometer

B) UV-Vis Spectrophotometer

C) Gas Liquid Chromatography

D) High Pressure Liquid Chromatography

A

39. Potency of a 100mg tablet at the expiry date:

A) 95mg B) 90mg C) 105mg D) 110mg

B

40. Inspection stations are placed in the following areas, except:

A) Analytical laboratory B) Manufacturing area C) Warehouse D) Packaging area

A

41. In the microbial assay of antibiotics, the microorganism used for Penicillin G is:

A) Staphylococcus aureus

B) Pseudomonas aeruginosa

C) Escherichia coli

D) Bacillus subtilis

A

42. The expiration date is:

A)The direct application and interpretation of the knowledge gained from the stability testing.

B)Used to limit the period during which a preparation may be expected to have its labeled potency, provided it has been stored as directed.

C)A and B are correct

D)A and B are incorrect

C

43. The period of stability of a preparation is the time from the date of manufacture of the formulation until its chemical or biological activity is not less than ___ of labeled potency:

A) 90% B) 95% C) 93% D) 99%

A

44. Which is not considered as a primary packaging component?

A) Bottles B) Vials C) Caps D) Packer boxes

D

45. Drug substances that are withheld from distribution until batch certification from BFAD has been received:

A) Antibiotics

B) Antineoplastics

C) Vitamins

D) All of the above

A

46. Factors that can be manipulated to accelerate instability:

A) Temperature B) Moisture C) Light D) All of the above

D

47. Cross-examination and mix up can happen in the following situations, except:

A)Improperly dispensed components

B)Wrong labels

C)Improper partitioning of production area

D)Components are kept in tightly-sealed containers

D

48. Content uniformity is to be performed for all tablets whose active ingredients are:

A) 50mg or less

B) 100mg or less

C) 50mg or more

D) None of the above

A

49. Which of the following is not a QC function?

A) In-process analysis

B) Inspection of container

C) Labeling and packaging materials

D) Inventory control

D

50. Total quality means:

A) Production is responsible for quality

B) Quality combines strict adherence to standard

C) Quality is everybody's business

D) All of the above

C

51. The presence of a cotton fiber in a liquid preparation is considered as a/an:

A) Internal defect B) Critical defect C) Ocular defect D) Variable defect

C

52. Materials to be sampled include the following, except:

A) Intermediate products B) Raw materials C) Records D) Final products

C

53. An analyst who determines the strength, potency and percentage purity of a drug or pharmaceutical product is

performing:

A) Special method B) Identification test C) Pharmaceutical assaying D) Pharmacopoeial test

C

54. The chemical factor used in calculation of percent purity of a substance in volumetric analysis:

A) mEq weight B) Molarity C) Titer D) A and C

D

55. The instrument used in measuring the optical activity of a sample:

A) Polarimeter B) Refractometer C) Spectrometer D) Flame photometer

A

56. In Azeotropic method for water analysis, the solvent that can be used is/are:

A) Water B) Toluene C) Xylene D) B and C

D

57. Adsorption indicators are used in:

A) Compleximetry B) Acidimetry C) Volumetric precipitation D) Alkalimetry

C

58. The moisture content of a drug may be:

A) Water of hydration B) Water in the absorbed form C) Water of emulsion D) A and B

D

59. The indicator used in permanganate titration:

A) Methyl orange B) Phenolphthalein C) Permanganate solution D) Methyl red

C

60. The indicator for EDTA direct titration of calcium carbonate:

A) Thymol blue B) Hydroxynaphthol blue C) Methyl red D) Methylene blue

B

61. Volatile oils are complex compounds composed of the following, except:

A) Phenols B) Fatty acids C) Hydrocarbons D) Aldehydes

B

62. The specific method for water content determination official in the USP/NF, except:

A) Karl Fischer method B) Azeotropic method C) Gravimetric method D) Dew point process

D

63. Safety or toxicity test for infusion plastic sets is conducted using:

A) Rabbits B) Dogs C) White mice D) Guinea pigs

C

64. In IR spectrometry, the finger print region is:

A) Near IR B) Medium IR C) Far IR D) A and B

B

65. To find the mEq factor of an oxidizing agent, divide the molecular weight by:

A) No. of electrons gained B) No. of electrons lost C) Valence D) Replaceable hydrogen

A

66. The type of chromatography where the cellulose of the filter paper is used as the adsorbent:

A) Column B) Gas C) Paper D) TLC

C

67. A parenteral is declared to be pyrogenic if the total rise in temperature of the rabbits is:

A) Less than 3.3oC in the 8 rabbits

B) More than 3.4oC in the 8 rabbits

C) More than 3.3oC in the 8 rabbits

D) B and C

C

68. Microbiological assay of antibiotics may be performed by using the following, except:

A) Test tube dilution B) Cylinder plate C) Paper disc D) Staining method

D

69. A term in compleximetry used to indicate a determination of a metal in the presence of another metal is:

A) Redox B) Masking C) Linking D) Complexing

B

70. Two substances reacting upon reaching the end point must have the same:

A) Normality B) Volume C) No. of equivalents D) Weight

C

71. All of the following are optical devices or instruments, except:

A) pH meter B) Spectrophotometer C) Colorimeter D) Flame photometer

A

72. The method of assay for sulfonamides is:

A) Acid-base titration B) Gravimetric C) Diazotization with nitrite D) Redox titration

C

73. Which of the following is a reducing agent?

A) Ascorbic acid B) KMNO4 C) Iodine D) Hydrochloric acid

A

74. In using spectrophotometer to measure the concentration of a sample, the following data were obtained:

absorbance of the standard solution = 0.39; absorbance of the sample solution = 0.42; concentration of the standard =

15mcg. The concentration of the sample is:

A) 16.15mcg B) 17.5mcg C) 15.75mcg D) 16.0mcg

A

75. Radiant energy required in the analysis of drugs under Fluorometry is in:

A) UV region B) Visible region C) IR region D) A and B

A

77. The method of assay for Vitamin B12 and calcium pantothenate is by:

A) Iodimetry B) Microbial-turbidimetric method C) Fluorometry D) Redox titration

B

78. The pH of a solution is usually measured by using:

A) Platinum electrode B) Glass electrode C) Mercury electrode D) Calomel electrode

B

80. In the assay of acetic acid (MW = 60.05), each mL of 1N NaOH is equivalent to:

A) 0.60000g of acetic acid C) 0.60050g of acetic acid

B) 0.00605g of acetic acid D) 0.06005g of acetic acid

B

81. Chemical analysis, which determines the amount or percentage content of a certain component in a sample:

A) Qualitative B) Proximate C) Quantitative D) Gravimetric

C

82. One of the fundamental laws in spectrophotometry is:

A) Law of Mass Action B) Beer's Law C) Boyle's Law D) Newton's law

B

83. The most effective way to clean glass apparatus:

A)Soaking in detergent C) Treatment with a solution of sodium chromate in sulfuric acid

B)Rinsing with nitric acid D) Acetic acid

C

84. Potentiometry finds application in:

A) Biologic assay B) pH determination C) Qualitative analysis D) A and B

B

85. If a 0.2250g of sodium bicarbonate (96.5% NaHCO3) is titrated with 0.1165N sulfuric acid. What volume of the acid

is required to reach the end point? At.Wt. of Na = 23; H = 1.0; C = 12; O = 16

A) 22.19mL B) 21.98mL C) 21.20mL D) 21.22mL

A

86. A sample of 0.1350g of arsenic trioxide (As2O3) was assayed iodimetrically using 23.4mL of 0.1055N iodine solution.

The percentage purity of the sample is:

A) 90.44 B) 89.10 C) 90.54 D) 90.23

B

87. In column chromatography, the separation of the sample mixture into a series of narrow bands in a column is:

A) Chromatogram B) Eluant C) Development D) A and C

B

88. In spectrophotometry procedure for assay, aside from the sample or unknown, this is also required:

A) Raw material of the sample B) Reference C) Dosage form D) A and C

B

89. The following conditions cause a reaction to go to completion, except:

A) Formation of a gas C) Formation of soluble products

B) Formation of a precipitate D) Formation of slightly ionized substances

C

90. Beer's plot in spectrometry is prepared to determine:

A) Absorbance of the sample C) Absorbance of the blank

B) Wavelength to be used D) Concentration of the sample

D

91. A plot of absorbance against concentration of a standard drawn in straight line is:

A) Charle's B) Beer's C) Lambert's D) B and C

C

92. The study of the optical activity of a substance is:

A) Polarimetry B) Refractometry C) Spectrophotometry D) Potentiometry

A

93. The unit of wavelength in spectrometry, except:

A) Nanometer B) Micron C) Millimeter D) Micrometer

C

94. Ways to prepare the sample for Infrared determination, except:

A) Use of Mull technique C) Use of alcohol as solvent

B) Use of potassium bromide pellet D) Use of liquid petrolatum as solvent

C

95. Chromatography can be used to separate compounds that are:

A) Colored B) Colorless C) Precipitate D) A and B

D

96. A water content determination method that uses Xylene tube is:

A) Gravimetry B) Karl Fischer titrimetry C) Azeotropic method D) Dew point method

C

97. Calculate the normality of sulfuric acid solution using 22.5mL. The volume of standardized NaOH used in the

standardization was 20.70mL, and its normality was 1.1055:

A) 1.0171 B) 1.1071 C) 1.0175 D) 1.0711

A

98. Calculate the calcium carbonate content of a sample of chalk weighing 0.2545g and consuming 16.67mL of 0.1150M

of EDTA solution in titration. At.Wt of Ca = 40.08; C = 12; O = 16. The percentage of CaCO3 is:

A) 75.52 B) 75.50 C) 37.76 D) 37.78

B

99. In the Statistical Quality Control, the chart used to measure the variations in the products inspected in the production:

A) Variable chart B) P-chart C) Attribute chart D) B and C

D

100. Substances that have the power of rotating the plane polarized light are said to be:

A) Light sensitive B) Active constituents C) Optically active D) Dextrorotatory

C

101. The indicator used in the assay of a weak acid reacting with a strong base is:

A) Methyl red TS B) Methyl orange TS C) Eriochrome black D) Phenolphthalein TS

D

102. The substance being analyzed is the:

A) Titrant B) Indicator C) Salt D) Analyte

D