PACOP - Quality Control (Green) Flashcards

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

A) EDTA method
B) Gravimetry
C) Nonaqueous titrimetry
D) Acidimetry

A

A

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

A) Ultimate
B) Specific
C) Extraction
D) Proximate

A

D

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3
Q
  1. 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

A

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4
Q
  1. 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

A

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

A) Sodium hydroxide
B) Caffeine
C) Citric acid
D) Zinc oxide

A

C

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

A) Aspirin
B) Sodium hydroxide
C) Hydrochloric acid
D) Zinc oxider

A

A

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7
Q
  1. 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

A

C

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

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

A

B

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9
Q
  1. 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

A

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10
Q
  1. A tool for detecting variations in a process:

A) Pie chart
B) Bar chart
C) Quality control chart
D) T-chart

A

C

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11
Q
  1. 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

A

D

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

A) Analytical control
B) Inspection control
C) Auditing
D) A and B

A

C

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13
Q
  1. 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

A

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14
Q
  1. 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

A

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

A) Fats
B) Sugars
C) Nitrogen
D) Oxygen in organic compounds

A

C

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

A) Carbon
B) Oil
C) Inorganic matter
D) Volatile component

A

C

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

A) Phenol content
B) Saturated fatty acids
C) Unsaponifiable matter
D) Unsaturated fatty acids

A

D

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

A) Volumetric
B) Gravimetric
C) Special method
D) Gasometric

A

B

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19
Q
  1. 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

A

C

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20
Q
  1. 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

A

B

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21
Q
  1. 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

A

B

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

A) Oxalic acid
B) Sodium thiosulfate
C) Chalk
D) Vinegar

A

A

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

A) Fats
B) Volatile oils
C) Alcohols
D) Fatty oils

A

C

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

A) Methyl orange
B) Phenolphthalein
C) Ferric alum
D) Methyl red

A

C

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25
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
26. Residual method titration with EDTA is applicable to what metal ion: A) Calcium B) Aluminum C) Zinc D) Magnesium
B
27
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
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
29. A buret with a glass stopcock can be used for: A) Alcohols B) Acids C) Bases D) Salts
B
30
30. Malic acid present in cherry juice may be determined by: A) Indirect permanganate oxidation method B) Direct permanganate oxidation C) Alkalimetry D) Acidimetry
A
31
31. Iodometry is an indirect analysis of: A) Oxidizing agents B) Reducing agents C) Acids D) Bases
A
32
32. The unsaponified matter present in animal fat is: A) Cholesterol B) Phytosterol C) Lard D) Wax
A
33
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
34. The crude fiber of a drug usually consist of: A) Cellulose B) Cholesterol C) Phytosterol D) None of the above
A
35
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
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
37. Amount of dissolved drug can be determined by: A) Analytical balance B) Dissolution tester C) Brookefield viscometer D) DOP spray
B
38
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
39. Potency of a 100mg tablet at the expiry date: A) 95mg B) 90mg C) 105mg D) 110mg
B
40
40. Inspection stations are placed in the following areas, except: A) Analytical laboratory B) Manufacturing area C) Warehouse D) Packaging area
A
41
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
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
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
44. Which is not considered as a primary packaging component? A) Bottles B) Vials C) Caps D) Packer boxes
D
45
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
46. Factors that can be manipulated to accelerate instability: A) Temperature B) Moisture C) Light D) All of the above
D
47
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
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
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
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
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
52. Materials to be sampled include the following, except: A) Intermediate products B) Raw materials C) Records D) Final products
C
53
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
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
55. The instrument used in measuring the optical activity of a sample: A) Polarimeter B) Refractometer C) Spectrometer D) Flame photometer
A
56
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
B
57
57. Adsorption indicators are used in: A) Compleximetry B) Acidimetry C) Volumetric precipitation D) Alkalimetry
C
58
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
59. The indicator used in permanganate titration: A) Methyl orange B) Phenolphthalein C) Permanganate solution D) Methyl red
C
60
60. The indicator for EDTA direct titration of calcium carbonate: A) Thymol blue B) Hydroxynaphthol blue C) Methyl red D) Methylene blue
B
61
61. Volatile oils are complex compounds composed of the following, except: A) Phenols B) Fatty acids C) Hydrocarbons D) Aldehydes
B
62
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
63. Safety or toxicity test for infusion plastic sets is conducted using: A) Rabbits B) Dogs C) White mice D) Guinea pigs
C
64
64. In IR spectrometry, the finger print region is: A) Near IR B) Medium IR C) Far IR D) A and B
B
65
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
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
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 3.4C in the 8 rabbits C) More than 3.3oC in the 8 rabbits D) B and C
C
68
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
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
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
71. All of the following are optical devices or instruments, except: A) pH meter B) Spectrophotometer C) Colorimeter D) Flame photometer
A
72
72. The method of assay for sulfonamides is: A) Acid-base titration B) Gravimetric C) Diazotization with nitrite D) Redox titration
C
73
73. Which of the following is a reducing agent? A) Ascorbic acid B) KMNO4 C) Iodine D) Hydrochloric acid
A
74
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
75
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
76
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
77
78. The pH of a solution is usually measured by using: A) Platinum electrode B) Glass electrode C) Mercury electrode D) Calomel electrode
B
78
79. Nuclear Magnetic Resonance (NMR) is used for: A) Radioisotopes B) Irradiation C) Identification of chemicals D) A and B
D
79
80. In the assay of acetic acid (MW = 60.05), each mL of 1N NaOH is equivalent to: A) 0.60000g of acetic acid B) 0.00605g of acetic acid C) 0.60050g of acetic acid D) 0.06005g of acetic acid
D
80
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
81
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
82
83. The most effective way to clean glass apparatus: A)Soaking in detergent B) Rising with nitric acid C) Treatment with a solution of sodium chromate in sulfuric acid D) Acetic acid
C
83
84. Potentiometry finds application in: A) Biologic assay B) pH determination C) Qualitative analysis D) A and B
B
84
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
85
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
A
86
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
87
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
88
89. The following conditions cause a reaction to go to completion, except: A) Formation of a gas B) Formation of a precipitate C) Formation of soluble products D) Formation of slightly ionized substances
C
89
90. Beer's plot in spectrometry is prepared to determine: A) Absorbance of the sample B) Wavelength to be used C) Absorbance of the blank D) Concentration of the sample
D
90
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
91
92. The study of the optical activity of a substance is: A) Polarimetry B) Refractometry C) Spectrophotometry D) Potentiometry
A
92
93. The unit of wavelength in spectrometry, except: A) Nanometer B) Micron C) Millimeter D) Micrometer
C
93
94. Ways to prepare the sample for Infrared determination, except: A) Use of Mull technique B) Use of potassium bromide pellet C) Use of alcohol as solvent D) Use of liquid petrolatum as solvent
C
94
95. Chromatography can be used to separate compounds that are: A) Colored B) Colorless C) Precipitate D) A and B
D
95
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
96
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
97
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
98
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
99
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
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
101
102. The substance being analyzed is the: A) Titrant B) Indicator C) Salt D) Analyte
D
102
103. In infrared spectrometry, water is not used as solvent for the sample because the water will: A) Absorb IR radiation B) Dissolve the sodium chloride cell holder C) Not dissolve the sample D) A and B
D
103
104. The law related to spectrometry wherein the power of transmitted light decreases exponentially as the thickness of the solution increases arithmetically is: A) Charle's B) Beer's C) Lambert's D) Henry's
C
104
105. The end point in iodimetry using starch TS as indicator is: A) Blue color B) Disappearance of blue color C) Greenish blue color D) A or C
B
105
106. The type of titration in ultimate assay of alkaloids is: A) Direct B) Residual C) Back D) B and C
D
106
107. What would be the aldehyde content of peppermint oil if the sample used was 15mL and the insoluble portion as read in the graduated neck of the Cassia flask was 2.2mL. The percentage of aldehyde content is: A) 85.33 B) 83.33 C) 84.30 D) 14.67
A
107
108. A sample of Magnesia Magma weighing 12.35g was dissolved in 50mL of 1.0340N sulfuric acid and titrated until end point is reached consuming 24.6mL of 1.1255N sodium hydroxide solution. The percentage of MgO content is: At.Wt. of Mg = 24.3: O = 16 A) 3.92 B) 4.0 C) 3.85 D) 3.91
A
108
109. The alcohol content of a volatile oil can be determined by: A) Bisulfite method B) Complexation process C) Acetylization process D) A and C
C
109
110. The index of refraction of a volatile oil can be determined by: A) Spectrophotometer B) Pycnometer C) Refractometer D) Polarimeter
C
110
111. Turbidimetric and nephelometric methods of assay are applied to: A) Suspensions B) Solutions C) Colored samples D) A and B
A
111
112. The adsorbent in the thin layer chromatography may be as follows, except: A) Alumina B) Silica gel C) Calcium oxide D) Silica gel G
C
112
113. Way to separate the constituents in gravimetric analysis: A) Neutralization process B) Physical means C) Chemical means D) B and C
D
113
114. Way to obtain the gram equivalent of a substance (GEW) is: A) Based on the replaceable H+ B) Based on the valence of the cation C) A or B D) Based on atomic weight
C
114
115. Expression of concentration in volumetric solutions, except: A) Normality B) Titer C) Molarity D) Molality
B
115
116. The assay procedures in volumetric precipitation were introduced by the following scientists, except: A) Arrhenius B) Mohr C) Fajan D) Volhard
A
116
117. The following are characteristics of a product with quality, except: A) Safe B) Acceptable C) Cheap price D) Effective therapeutically
C
117
118. The terms used when equivalent amounts of each reactant have reacted are the following, except: A) End point B) Equivalence point C) Stoichiometric pont D) Theoretical point
A
118
119. Constant weight in analytical procedures of drying means that consecutive weighing after heating and cooling do not differ by: A) More than 0.25mg B) More than 0.50mg C) More than 0.255mg D) Not more than 0.75mg
A
119
120. The concentration of an unknown sample in spectrophotometric procedures can be calculated by: A) Use of Beer's plot B) Use of chemical factor C) Use of mathematical formula using a reference standard data D) A or C
D
120
121. In thin layer chromatography, finding the spot of the colorless compound in the chromatogram can be done by: A) Use of sulfuric acid spray to obtain a brown color B) Use of ultraviolet radiation C) Use of carbon tetrachloride spray D) A or B
D
121
122. In paper chromatography, the data needed to compute for Rf value: A) Distance traveled by the solute B) Distance traveled by the solvent C) A and B D) Distance traveled by the blank
C
122
123. The mobile phase in the gas chromatography is consists of: A) Alcohol-ethyl acetate mixture B) Alcohol-chloroform mixture C) Inert gas D) A and B
C
123
124. In gas chromatography, the result in the chromatogram is in terms of: A) Retention on the column B) Retention of time/volume C) A and B D) Volume of sample injected in the column
C
124
125. The components of a blank used in the assay of a substance are, except: A) Solvent B) Reagent C) Indicator D) Analyte
D
125
126. The purpose of using a combination of indicators is: A) To attain a sharp end point B) To facilitate reaction C) To attain a complete reaction D) A and B
A
126
127. The purity and strength of chemicals and drugs official in the USP/NF is usually expressed in terms of: A) Percentage B) g/mL C) mg/mL D) g/L
A
127
128. The gram equivalent of Magnesium oxide (MW = 40.30) is: A) 0.0403 B) 0.0215 C) 21.15 D) 0.4030
C
128
129. A sample of potassium dichromate (K2Cr2O7) weighing 1.5650g was assayed iodometrically using 26.6mL of 0.1120N sodium thiosulfate. Each mL of 0.1N sodium thiosulfate is equivalent to 49.03mg of K2Cr2O7. The percentage purity of the sample is: A) 93.50 B) 95.33 C) 93.33 D) 93.40
C
129
130. Nephelometry is based on the measurement of light that is: A) Refelected B) Absorbed C) Transmitted D) Adsorbed by the particles of a suspension
A
130
131. The infrared region of the spectrometer used to identify a substance has a wavelength range of: A) 200 - 380 nm B) 380 - 780 nm C) 780 - 3000 nm D) 3 - 15 m
D
131
132. Flame spectroscopy procedures may be divided into: A) Flame emission B) Atomic absorption C) Nuclear magnetic resonance D) A and B
D
132
133. The instrument used to measure sodium and potassium ions quantitatively: A) Colorimeter B) Refractometer C) Spectrophotometer D) Flame photometer
D
133
134. The following are optical methods of analysis, except: A) Colorimetry B) Nephelometry C) Chromatography D) Spectrophotometry
C
134
135. The calcium and sodium content of the blood can be determined by: A) Flame spectrometry B) Nephelometry C) Colorimetry D) Turbidimetry
A
135
136. Thiamine is assayed by: A) Refractometry B) Potentiometry C) Colorimetry D) Fluorimetry
D
136
137. The term given to the functional group of an organic molecule that absorbs maximum radiation in UV or IR region is: A) Moiety B) Carbonyl C) Chromophore D) Nitrile
C
137
138. Content uniformity test is conducted in: A) 10 tablets B) 15 tablets C) 20 tablets D) 30 tablets
A
138
139. It is the number of complete cycles that pass a given point per second: A) Wavelength B) Spectrum C) Radiant energy D) Frequency
D
139
140. The operating speed for paddle in a dissolution apparatus is: A) 150 rpm B) 100 rpm C) 200 rpm D) 50 rpm
D
140
141. Beer's plot in spectrometry is prepared to determine: A) Absorbance of the sample B) Wavelength to be used C) Blank D) Concentration of the sample
D
141
142. The pharmaceutical excipient, which affects the disintegration of a tablet is: A) Disintegrant B) Lubricant C) Filler D) Colorant
A
142
143. Antibiotics are assayed by: ``` A) UV-Vis Spectrometry B) IR C) NMR D) Turbidimetry E) Fluorimetry ```
D
143
144. USP limit for tablet content uniformity: A) 90 - 110% B) 90 - 100% C) 95 - 105% D) 85 - 115%
D
144
``` 145. The heart of HPLC and GC: A) Pumps B) Injection valve C) Column D) Detectors E) Integrator ```
C
145
146. Gas chromatography is used in the separation of: ``` A) Volatile liquids B) Amino acid C) Carbohydrates D) Lipids E) Carboxylic acid ```
A
146
147. In TLC, the separation takes place on a planar surface by: ``` A) Dufferential migration B) Electrostatic force C) Relative solubility D) Capillary action E) Any of the above ```
D
147
``` 148. The separation of the components of an organic dye mixture is accomplished by using: A) PC B) TLC C) HPLC D) GC E) Any of the above ```
B
148
149. This is the primary cause of product instability and involves the addition of oxygen or the removal of hydrogen: ``` A) Incompatibility B) Oxidation-Reducation C) Hydrolysis D) Racemization E) Decarboxylation ```
B
149
150. This is the method of analysis based on the measurement of current resulting from the electrolysis of an electroactive species at a given electrode potential under controlled condition: ``` A) Potentiometry B) Polarimetry C) Polarography D) Refractometry E) pH measurement ```
A
150
151. The most preferred medium in dissolution testing is: ``` A) Alcohol B) Acetone C) Ether D) Water E) Benzene ```
D
151
152. The following are the basic principles behind chromatographic separation, except: A) Partition B) Adsorption C) Absorption D) Ion-exchange
C
152
153. The stationary phase used in gas chromatography is: ``` A) Gas B) Liquid C) Substrate D) Cellulose E) Chromatogram ```
B
153
154. The most widely used chromatographic method in drug analysis is: ``` A) GC B) LLC C) HPLC D) SLC E) TLC ```
C
154
155. In gas chromatography, the result of the assay is expressed in: ``` A) Retention on the column B) Rf value C) Volume of gas used D) Adsorbent E) A and C ```
A
155
156. In column chromatography, the resulting patterns with several bands is called: ``` A) Chromatogram B) Eluate C) Spectrum D) Band E) A and C ```
A
156
157. Color of phenolphthalein in vinegar: A) Pink B) Yellow C) Colorless D) Orange]
C
157
158. The primary standard used in the standardization of potassium permanganate is: A) Hydrogen peroxide B) Sulfuric acid C) Potassium dichromate D) Sodium oxalate
D
158
``` 159. An organic compound that changes from one color to another at a certain pH is called: A) Test solution B) Standard solution C) Buffer D) Indicator ```
D
159
160. To find the gram equivalent weight of Phosphoric acid, divide its molecular weight by: A) 1 B) 0 C) 2 D) 3
D
160
161. A combining molecule containing one or more groups that donate electrons will form ____ with a metal. A) Complex B) Chelate C) Sequestering agent D) Masking agent
B
161
162. A chelate must always contain a/an: A) Multivalent metal B) Ethylenediamine group C) Amine group D) Triple bond
A
162
163. The assay of Menadione Sodium Sulfate (Vit. K) uses this method of analysis: A) Gravimetric method B) Acid base titration C) Precipitation method D) Redox titration
D
163
164. In the standardization of HCl using pure anhydrous sodium carbonate as primary standard and methyl orange as indicator, 1.0mL HCl was found to be equivalent to 0.05g of sodium carbonate (MW = 106). The normality of HCl is: A) 1.0 N B) 0.94 N C) 0.4716 N D) None of the above
B
164
165. An accurately measured sample of hydrogen peroxide 2.00g was dissolved in a mixture of 20mL water and 20mL and 20mL diluted sulfuric acid and was then titrated with 0.100N potassium permanganate consuming 30.0mL to reach the end point. Compute for the percentage of peroxide (MW = 34) A) 2.55% B) 5.1% C) 2.5% D) None of the above
A
165
166. USP requires not less than 2.5g and not more than 3.5g of hydrogen peroxide /100 parts. Does the sample conforms with the standard requirement? A) Yes B) No C) Maybe D) Cannot be determined
A
166
167. One twentieth molar solution of sulfuric acid is: A) 0.05 M B) 0.1 M C) 0.005 M D) 0.5 M
A
167
168. Precipitation method using potassium chromate test solution as indicator and silver nitrate standard solution: A) Volhard B) Fajan C) Mohr D) None of the above
C
168
169. The titrant most commonly used for direct compleximetry titration is: A) Zinc sulfate B) EDTA C) AgNO3 D) HclO4
B
169
170. The titer value of 1.0mL of 0.1N ceric sulfate for arsenic trioxide (MW = 197.94) A) 9.496 mg B) 197.84 mg C) 9.892 mg D) 14.838 mg
A
170
171. The masking agent used in the assay of Mg with EDTA in the presence of Al is: A) Triethanolamine B) Thioglycol C) Potassium cyanide D) Ammonium fluoride
A
171
172. In the assay of ZnO (MW = 81.38), each mL of 1N of H2SO4 is equivalent to ____ of ZnO. A) 81.38 mg B) 40.69 mg C) 27.13 mg D) 20.34 mg
B
172
173. The substance used to form a film over the precipitated silver chloride particles in Volhard's method is: A) Nitric acid B) Sodium chloride C) Triethanolamine D) Nitrobenzene
D
173
174. Assay of Sodium Nitrite is an example of: A) Neutralization B) Precipitation C) Complexation D) Redox method
D
174
175. Assay of NaCl in table salt by precipitation as AgCl, filtration, drying and weighing the residue is classified as: A) Direct precipitimetry B) Volhard's method C) Gravimetry D) Residual precipitimetry
C
175
176. Ceric sulfate is a/an: A) Precipitating agent B) Oxidizing agent C) Reducing agent D) Complexing agent
B
176
177. The valence number of Mn in KMNO4 is: A) +2 B) +1 C) +5 D) +7
D
177
178. The apparatus used to wash down drops of standard solution clinging to the tip of the buret is: A) Bobcock bottle B) Cassia flask C) Acetylization flask D) Wash bottle
D
178
179. An sample of sodium sulfate weighing 1.800g yielded 0.900g of barium sulfate (MW = 233.25). Calculate the percentage of sulfur ( AW = 32.06) in the sample. A) 12.18% B) 6.870% C) 27.48% D) 30.44%
B
179
180. How many grams of drug are required to make 500 mL of 25.0% solution? A) 30.0 g B) 50.0 g C) 125 g D) 130 g
C
180
181. The following are methods of determining the end point in precipitimetry, except: A) Use of adsorption indicators B) Cessation of precipitation C) Formation of turbidity D) Appearance of turbidity
C
181
182. The reagent that loses the electron/s in a redox reaction is the: A) Substance that decreases in oxidation number B) Oxidizing agent C) Reducing agent D) Substance reduced
B
182
183. A substance that has a high degree of purity and is used in direct standardization purposes: A) Technical grage B) CP grade C) Any of the answers D) Primary standard
D
183
184. The type of assay employed in determining the % ZnO in a sample of Zinc White Powder using EDTA as titrant is: A) Volhard's method B) Direct precipitimetry C) Direct compleximetry D) Residual Compleximetry
C
184
185. The experimental way of determining when equivalent amounts of reactants have reacted together is: A) Titration B) Stoichiometric point C) Standardization D) Equivalence point
A
185
186. Calculate the calcium carbonate content of a sample of chalk weighing 0.2545g and consuming 16.7 mL of 0.1150 M EDTA. At. Wt. Of Ca = 40.08 A) 75.52% B) 75.50% C) 37.76% D) 37.78%
A
186
187. Twenty tablets of ascorbic acid weighed 4.2500g and a powdered sample of 0.3075g was titrated consuming 21.5mL of 0.1085N Iodine solution. Each mL of 0.1N Iodine is equivalent to 8.80mg of ascorbic acid. What is the amount of ascorbic acid per dose of two tablets? A) 283.72 mg B) 141.86 mg C) 283.22 mg D) A and C
A
187
188. The official USP gravimetric methods are: 1. Assay involving direct ignition 2. Assay involving sublimation 3. Assay involving extraction 4. Assay involving precipitation followed by ignition A) 1, 3 and 4 B) 2, 3 and 4 C) 1, 2 and 4 D) 1, 2 and 3
A
188
189. Hexane is the best solvent for extracting: A) Resins B) Fats C) Volatile oils D) Acids
B
189
190. Alkaloidal test solutions include: A) Valser's TS B) Warner's TS C) Mayer's TS D) Any of the above
D
190
191. How many mL of water is expected from a 20 g Digitalis sample containing 1.5% moisture? A) 0.3 mL B) 30 mL C) 3 mL D) None of the above
A
191
196. Find the acid value of a sample weighing 1.230 g that consumes 30.0 mL pf 0.110 N NaOH to bring about the end point using KOH in the titration: A) 150.54 mg/g B) 157.72 mg/g C) 109.18 mg/g D) 124.41 mg/g
A
192
197. During an in-process control testing, the following data were obtained from loss on drying test: Wt. of sample before drying 1.146 g Wt. of tare & sample after drying 25.653 g Wt. of tare 24.632 g ``` What is the weight of moisture lost? A) 1.021 g B) 0.125 g C) 1.125 g D) 0.021 g ```
B
193
198. Calculate the water content of an antibiotic powder using 350mg sample. The water equivalence factor (F) of the Karl Fischer reagent is 4.6 and the volume of the reagent used was 9.2 mL. The % of water content is: A) 12.09% B) 1.21% C) 12.11% D) A and B
A
194
199. Determination of iodine value of oils depends on: A) Substitution with iodine for the hydrogen in the fatty acid B) Addition of iodine at the double bond of the fatty acid C) Oxidation of the fatty acid by iodide D) All of the above
B
195
200. The soluble constituents of crude drug in a certain solvent: A) Extractive B) Ash C) Crude fiber D) Phytosterol
A
196
201. In-process specification requires that the percent loss on drying should not exceed 0.65% of the sample weight. Based on the given data below, what is the total amount of moisture? Tare wt. 26.839 g Gross wt. 36.506 g Gross wt. after drying 36.495 g A) 0.237 g B) 0.060 g C) 9.607 g D) 0.011 g
D
197
202. A reaction is led to completion by: A) Formation of ash B) Formation of insoluble acid C) Production of slightly ionized molecules D) All of the above
D
198
203. Karl Fischer electrometric titration is a method used to assay for its: A) Oxygen content B) Nitrogen content C) Carbonate content D) Water content
D
199
204. The primary standard used to standardize Karl Fischer reagent is: A) Anhydrous sodium carbonate B) Potassium bipthalate C) Sodium tartrate D) Sodium oxalate
C
200
205. Assay of atropine in Belladonna is an example of: A) Proximate assay B) Ultimate assay C) Both A and B D) Neither A nor B
B
201
206. Oils with iodine value above 120 are classified as: A) Non-drying B) Semi-drying C) Drying D) None of the above
C
202
207. If a sample is beeswax is found to have an acid number of 15.5 and a saponification value of 71.2, the ester value of the sample is: A) 86.7 B) 55.7 C) 90 D) None of the above
B
203
208. The temperature for ignition described as dull red heat is: A) 500 - 1000 oC B) 550 - 700 oC C) 500 - 750 oC D) 300 - 450 oC
B
204
209. The assay of the aldehyde content of volatile oils may be done by: A) Extraction B) Bisulfite method C) Bobcock method D) Gravimetric method
B
205
210. Quantitative determinations of alkaloids may be done by: A) Volumetric B) Gravimetric C) Spectrophotometric D) Any of the above
D
206
211. Calculate percentage of Atropine in Belladonna powder using 10.7 g sample and adding 20 mL of 0.0225N H2SO4 and back titrated with 12.5 mL of 0.0295N NaOH. Each mL of 0.02N H2SO4 is equivalent to 5.788g of Belladona alkaloids in terms of Atropine. A) 5.60% B) 0.56% C) 0.59% D) 0.22%
D
207
212. Calculate the normality of sulfuric acid solution using 22.15 mL of it. The volume of NaOh used in the standardization was 20.75 mL and its normality was 1.1055. A) 1.0356 B) 1.3056 C) 1.0035 D) 1.0030
A
208
213. Compute for the iodine value of corn oil 0.2048g dissolved in 10 mL chloroform and 25 mL iodobromide TS was added, mixed and allowed to stand for one hour. Thirty mL of KI TS and 100 mL distilled water were added and titrated with 10 mL of 0.1065 N sodium thiosulfate. The volume of sodium thiosulfate consumed in the blank was 25.7. I is equal to 126.9. A) 103.61 B) 103.16 C) 101.36 D) 103.66
A
209
214. This is the acceptable tablet hardness range of chewable tablets: A) 4 - 10 kg B) 2 - 3 kg C) 5 - 8 kg D) 2 - 8 kg
B
210
215. How many samples should be tested if a batch consists of 120 bottles of paracetamol suspension when the square root method is used? A) 12 B) 11 C) 10 D) 9
A
211
216. In normal phase chromatography: A) Stationary phase and mobile phase are both polar B) Stationary phase is nonpolar, mobile phase is polar C) Stationary phase is polar, mobile phase is nonpolar D) Stationary phase and mobile phase are both nonpolar
C
212
217. Fats are: A) Esters of glycerin and fatty acid B) Polypeptides C) Compounds of glycerol, fatty acid. Phosphoric acid and choline D)Steroids with one or more hydroxyl groups E) Esters of fatty acids with high molecular weight alcohol
A
213
218. Acid insoluble ash is the part of the total ash, which is insoluble in: A) Dilute nitric acid B) Acetic acid C) Dilute sulfuric acid D) Dilute hydrochloric acid
D
214
219. What would be the accepted weight range of tablets weighing 130mg? A) 123.5 - 136.5 mg B) 120.25 - 139.75 mg C) 117 - 123 mg D) 120.9 - 139.1 mg
B
215
220. Disintegration test is done at this temperature: A) 36.5 - 37.5 oC B) 36 - 37 oC C) 35 - 39 oC D) 37 oC
C
216
221. Efficiency of HEPA filters is assessed using: A) DOP test B) Water attack test C) Carr's index D) Bubble point test
A
217
222. A concentration expression referring to the number of equivalents of solute per liter of solution is: A) Normality B) Molarity C) Molality D) Formality
A
218
223. A solution of known concentration used to standardize another solution is: A) Primary standard B) Dilute solution C) Secondary standard D) B ans C
A
219
224. Water attack test is used in this type of glass container: A) Type I B) Type II C) Type III D) Type IIII
B
220
225. A person who determines the presence of pyrogens and microorganisms of a pharmaceutical product is performing: A) Special method B) Identification test C) Pharmaceutical assaying D) Pharmacopoeial test
A
221
226. The process by which the exact concentration of a solution is determined is: A) Standardization B) Neutralization C) Redox D) Acidimetry
A
222
227. The apparatus used to keep samples free from moisture is: A) Oven B) Dessicator C) Furnace D) A and C
B
223
228. Materials being controlled by Quality Control, except: A) Active ingredient B) Excipients C) Finished products D) Packages
D
224
229. To assure stability of the product until expiry date, the label should indicate: A) Proper storage B) Proper dosage C) Proper color D) Proper drug administration
A
225
230. Neutralization reactions in titrimetric methods of analysis may be: A) Precipitimetry B) Alkalimetry C) Compleximetry D) A and C
B
226
231. The type of ligand where EDTA belongs; A) Unidentate B) Bidentate C) Hexadentate D) Tridentate
C
227
232. To remove stains of iodine, the most effective chemical substance is: A) Calamansi juice B) Hydrogen peroxide C) Sodium thiosulfate D) Sodium hypochlorite
C
228
233. A type of titration where the first titrant is added in excees with the sample and the second titrant reacts with the added excess is: A) Back B) Direct C) Residual D) A and C
B
229
234. Light scattering method of analysis include/s: A) Flourometry B) Turbidimetry C) Nephelometry D) B and C
D
230
235. Ferric alum TS is used as indicator in volumetric precipitation method if the titrant is: A) AgNO3 B) BaCl2 C) NH4SCN D) NH4Cl
C
231
237. In gravimetric analysis, when the process used in extraction to obtain the original constituent, this method belongs to: A) Chemical B) Physical C) Precipitation D) Any of the above
B
232
238. To find the milliequivalent factor of a reducing agent, divide its molecular weight by: A) No. of electrons gained B) Valence C) No. of electrons lost D) Replaceable hydrogen
C
233
239. A spectrophotometer differs from a colorimeter because it consists of: A) Prism B) Lamp house C) Cell compartment D) Optical scale
A
234
240. Compute for the angle of repose of the sample powder using fixed funnel method if the height and diameter obtained was 5 cm and 13 cm respectively. A) 37.57o B) 36.57o C) 35.75o D) 36o
A
235
241. Volatile oils are complex compounds composed of: A) Phenols B) Inorganic salts C) Hydrocarbons D) A and C
D
236
242. The name of originator who introduced the adsorption dyes as an indicator in volumetric precipitation method: A) Volhard B) Charles C) Mohr D) Fajan
D
237
243. The acid necessary for permanganate titrations is: A) Acetic acid B) Sulfuric acid C) Hydrochloric acid D) Nitric acid
B
238
244. Using a sampling plan by military standard 105 D, the sample size required is obtained from: A) Master table B) Ratio and proportion C) Samples needed D) A and B
A
239
245. To control finished products in the warehouse of a company, the distribution practice is: A) First-in first-out B) Samples needed C) Ratio and proportion D) A and B
A
240
246. The number of retention samples collected by the Quality Control Inspector from the packaging line is: A) Two times the number required for testing B) Three labeled containers C) Not less than two labeled containers D) Any of A and C
D
241
247. A type of quality control chart based on the number of defectives found is: A) Go or no-go B) Variable C) Attribute D) A and C
D
242
248. Sources of quality variations are as follows, except: A) Technician B) Inadequate procedure C) Equipment D) General manager
D
243
249. Acetylation method of analysis in volatile oils is done to determine: A) Phenol B) Aldehyde C) Alcohol D) Ketone
C
244
250. In spectrometry, when a test solution is prepared and observed identically with a reference standard, they are: A) Isometric substances B) Similar solutions C) Similar preparations D) B and C
D
245
For numbers 20 - 23: The following data were obtained after the moisture and total ash content determination of acacia powder: Wt. of empty crucible 52.452 g Wt. of crucible & sample 61.648 g Wt. of crucible & sample after drying to constant wt. 60.502 g Wt. of crucible and residue left after incineration 53.006g 192. Moisture content in grams: A) 1.146 B) 1.144 C) 1.164 D) 1.166
A
246
For numbers 20 - 23: The following data were obtained after the moisture and total ash content determination of acacia powder: Wt. of empty crucible 52.452 g Wt. of crucible & sample 61.648 g Wt. of crucible & sample after drying to constant wt. 60.502 g Wt. of crucible and residue left after incineration 53.006g 193. Percent moisture: A) 12.64% B) 12.46% C) 12.45% D) 12.54%
B
247
For numbers 20 - 23: The following data were obtained after the moisture and total ash content determination of acacia powder: Wt. of empty crucible 52.452 g Wt. of crucible & sample 61.648 g Wt. of crucible & sample after drying to constant wt. 60.502 g Wt. of crucible and residue left after incineration 53.006g 194. Total ash content in grams: A) 0.545 B) 0.555 C) 0.554 D) 0.445
C
248
1. Most of the official drugs containing calcium and zinc are assayed by: A) EDTA method B) Gravimetry C) Nonaqueous titrimetry D) Acidimetry
A
249
2. Type of alkaloidal assay where the total alkaloids are determined: A) Ultimate B) Specific C) Extraction D) Proximate
D
250
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
251
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
252
5. The following compounds are assayed by acidimetrically, except: A) Sodium hydroxide B) Caffeine C) Citric acid D) Zinc oxide
C
253
6. Which of the following substances is assayed by residual alkalimetric analysis? A) Aspirin B) Sodium hydroxide C) Hydrochloric acid D) Zinc oxider
A
254
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
255
8. Materials to be sampled include the following, except: A) Final products B) Records C) Intermediate products D) Raw materials
B
256
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
257
10. A tool for detecting variations in a process: A) Pie chart B) Bar chart C) Quality control chart D) T-chart
C
258
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
259
12. The functions of Quality Control include the following, except: A) Analytical control B) Inspection control C) Auditing D) A and B
C
260
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
261
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
262
15. The Kjeldahl method of analysis is used to determine: A) Fats B) Sugars C) Nitrogen D) Oxygen in organic compounds
C
263
16. The ash content of an organic compound is an impurity of: A) Carbon B) Oil C) Inorganic matter D) Volatile component
C
264
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
265
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
266
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
267
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
268
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
269
22. The most effective chemical substance in removing stains of potassium permanganate: A) Oxalic acid B) Sodium thiosulfate C) Chalk D) Vinegar
A
270
23. The ester value determination of substances is applicable to the following, except: A) Fats B) Volatile oils C) Alcohols D) Fatty oils
C
271
24. The following are indicators used for acid-base titrations, except: A) Methyl orange B) Phenolphthalein C) Ferric alum D) Methyl red
C
272
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
273
26. Residual method titration with EDTA is applicable to what metal ion: A) Calcium B) Aluminum C) Zinc D) Magnesium
B
274
27. Chemical reactions that involves a change in the valence number of reacting substances: A) Neutralization B) Complexation C) Oxidation-reduction D) Precipitation
C
275
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
276
29. A buret with a glass stopcock can be used for: A) Alcohols B) Acids C) Bases D) Salts
B
277
30. Malic acid present in cherry juice may be determined by: A) Indirect permanganate oxidation method B) Direct permanganate oxidation C) Alkalimetry D) Acidimetry
A
278
31. Iodometry is an indirect analysis of: A) Oxidizing agents B) Reducing agents C) Acids D) Bases
A
279
32. The unsaponified matter present in animal fat is: A) Cholesterol B) Phytosterol C) Lard D) Wax
A
280
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
281
34. The crude fiber of a drug usually consist of: A) Cellulose B) Cholesterol C) Phytosterol D) None of the above
A
282
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
283
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
284
37. Amount of dissolved drug can be determined by: A) Analytical balance B) Dissolution tester C) Brookefield viscometer D) DOP spray
B
285
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
286
39. Potency of a 100mg tablet at the expiry date: A) 95mg B) 90mg C) 105mg D) 110mg
B
287
40. Inspection stations are placed in the following areas, except: A) Analytical laboratory B) Manufacturing area C) Warehouse D) Packaging area
A
288
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
289
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
290
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
291
44. Which is not considered as a primary packaging component? A) Bottles B) Vials C) Caps D) Packer boxes
D
292
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
293
46. Factors that can be manipulated to accelerate instability: A) Temperature B) Moisture C) Light D) All of the above
D
294
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
295
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
296
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
297
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
298
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
299
52. Materials to be sampled include the following, except: A) Intermediate products B) Raw materials C) Records D) Final products
C