Quality Control PACOP GREEN

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

A) EDTA method

B) Gravimetry

C) Nonaqueous titrimetry

D) Acidimetry

B

2. Type of alkaloidal assay where the total alkaloids are determined: A) Ultimate B) Specific C) Extraction D) Proximate

B

3. Limulus ameobocyte lysate (LAL) assay method 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

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

6. Which of the following substances is assayed by residual alkalimetric analysis? A) Aspirin B) Sodium hydroxide C) Hydrochloric acid D) Zinc oxide

A

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 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 C) Research and development studies B) Analytical testing laboratory 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) lodine 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 ImL 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.IN 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) Zine 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) lodometry D) lodimetry

C

29. A buret with a glass stopcock can be used for: A) Alcohols B) Acids C) Bases D) Salts

B

30. Malic acid present in cherry juice may be determined by: A) Indirect permanganate oxidation method C) Alkalimetry B) Direct permanganate oxidation method 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 C) Validation program B) All of the answers 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 C) Gas Liquid Chromatography B) UV-Vis Spectrophotometer 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 C) Escherichia coli B) Pseudomonas aeruginosa 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 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 C) Quality is everybody's business B) Quality combines strict adherence to standard 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) Pharmacopocial 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) Açidimetry C Volumetric precinitation 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 the total rise in temperature of the rabbits is: A) Less than 3.3°C in the 8 rabbits C) More than 3.3°C in the 8 rabbits B) More than 3.4°C 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) KMNO, C) lodine 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

C

76. 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 B, and calcium pantothenate is by: A) lodimetry 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

79. Nuclear Magnetic Resonance (NMR) is used for: A) Radioisotopes B) Irradiation C) Identification of chemicals D) A and B

C

80. In the assay of acetic acid (MW = 60.05), each mL of IN 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

D

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% NaHCO,) 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; 0 = 16 A) 22.19mL. B) 21.98mL C) 21.20mL D) 21.22ml

A

86. A sample of 0.1350g of arsenic trioxide (As,0,) 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

A

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

C

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

B

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; 0 = 16. The percentage of CaCO, 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

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