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Quality Control Answer Key GREEN PACOP 1
Quality Control Answer Key GREEN PACOP 1
Quality Control Answer Key GREEN PACOP 1
a. Ferric alum
b. Fe NH4 (SO4)2
c. Fe (NH4)2(SO4)2
d. A and B
e. A and C
a. I only
b. I and II only
c. I, II, and III
d. I, II, III and IV
a. % w/w
b. % w/v
c. Both a and b
d. None of the choices
a. Disodium edetate
b. Silver nitrate
c. Sodium Methoxide
d. Perchloric acid
5. Use to prevent one element from interfering in the analysis of another element
a. Masking agent
b. Demasking agent
c. Both a and b
d. None of the choices
a. Magnesium
b. Sodium
c. Silver
d. Potassium
a. Acid-base
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b. Adsorption
c. Metal-ion
d. None of the choices
9. Solutions 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
a. Accuracy
b. Precision
c. Range
d. Standard deviation
a. Benzoic acid
b. Sodium bicarbonate
c. Sodium carbonate
d. Potassium hydrogen phthalate
13. 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
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a. Determinate
b. Indeterminate
c. Random
d. Both b and c
a. Silver nitrate
b. Ammonium thiocyanate
c. Edetate disodium
d. All of the choices
16. The end point of using number ferric ammonium sulfate is:
a. White precipitate
b. Red-brown color
c. Pink color
d. Blue color
a. 0.5 %
b. 0.05 %
c. 0.2 %
d. 0.02 %
a. Na2C4H4O6
b. H2O
c. Both a and c
d. None of the choices
19. A ligand that binds to a metal ion through only one atom.
a. Monodentate
b. Bidentate
c. Tridentate
d. Tetradentate
20. Which of the following is added to maintain the pH of sodium thiosulfate in optimum
range for the stability of the solution?
a. Sodium bicarbonate
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b. Chloroform
c. Thymol
d. Sodium carbonate
a. perchloric acid
b. hydrogen bromide
c. both a and b
d. none of the choices
a. test solutions
b. volumetric solutions
c. saturated solution
d. none of the choices
a. redox
b. neutralization
c. diazotization
d. all of the choices
e. a and b only
a. Solubilizing agent
b. Change in pH of the solution
c. As preservative
d. All of the choices
a. eosin Y
b. crystal violet
c. ferroin
d. ferric alum
27. Color of the complex resulting from reaction with ferrous phenanthroline:
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a. blue
b. red
c. pink
d. violet
29. In the standardization of iodine solution, why is there a need to boil the solution of
arsenic trioxide?
a. Oxidizing agent
b. Reducing agent
c. Both a and c
d. None of the choices
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35. The equilibrium constant for the reaction of the metal ion with a ligand is called _____.
a. Formation constant
b. Solubility product constant
c. Solubility constant
d. None of the choices
a. Increases
b. Decreases
c. No effect
d. None of the choices
a. Increases
b. Decreases
c. No effect
d. None of the choices
a. Starch TS
b. KMnO4
c. Methyl red TS
d. Methyl orange
39. Developed in 1883, this method of analysis remains as one of the accurate and widely
used method for determining nitrogen in substance.
a. Non-aqueous titrimetry
b. Precipitation
c. Redox itration
d. Kjeldahl method
a. Methyl red TS
b. Methyl orange TS
c. Phenolphthalein
d. All of the choices
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a. I only
b. I and II only
c. I, II, and III
d. I, II, III and IV
46. When a weak base is to be titrated with weak acid, the indicator used is:
a. Phenolphthalein
b. Methyl orange
c. Methyl red
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d. No indicator is suggested
48. The used of sodium bicarbonate in the standardization of iodine solution ______.
a. Macromethod
b. Semimicro method
c. Both a and c
d. None of the choices
50. To keep samples moisture free, the appropriate apparatus to use is:
a. Desiccator
b. Separatory funnel
c. Furnace
d. Incubator
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53. A 0.2185 g sample of NaCl was assayed using Volhard method using 50 mL of 0.998N
silver nitrate and 11.9 mL of 0.1350N ammonium thiocyanate. Calculate the NaCl in the
sample. MW NaCl = 58.45
a. 42.6
b. 62.4
c. 90.5
d. 6.24
54. A 4.59 mL sample of HCl, specific gravity 1.3, required 50.5 mL of 0.9544N NaOH in a
titration. Calculate the % w/w HCl.
a. 29%
b. 1%
c. 92%
d. 69%
55. What is the titer value for 0.05 M calcium chloride with 2 moles of water? MW= 142.9
a. 3.57 mg
b. 7.15 mg
c. 73.5 mg
d. 53.7 mg
56. 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/v. MW=98
a. 10%
b. 20%
c. 30%
d. 40%
57. Limestone consists mainly of the mineral calcite, CaCO3. The carbonate content of
0.5413 g of powdered limestone was measured by suspending the powder in water,
adding 10 mL of 1.392 M HCl and heating to dissolve the solid and expel CO2. The
excess acid required 39.96 mL of 0.1004 M NaOH for complete titration to a
phenolphthalein end point. Find the weight % of the calcite in the limestone. MW=100
a. 29%
b. 39%
c. 92%
d. 96%
58. The Kjeldahl procedure was used to analyzed 256µL 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
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59. How many grams of Cupric (II) Sulfate pentahydrate should be dissolves in a volume of
500 ml to make 8 X 10-3 M solution?
MW= 249.54
a. 0.998
b. 9.98
c. 99.8
d. 109.1
60. 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?
a. 1.65
b. 6.53
c. 16.53
d. 165.3
61. A solution with a final volume of 500 mL was prepared by dissolving 25 mL of methanol
(density= 0.7914 g/mL) in chloroform. Calculate the molarity of methanol in the solution.
MW= 32.
a. 0.12
b. 1.24
c. 12.4
d. 124
62. The above solution (question no.61) has a density of 1.454 g/mL. Find the molality of
methanol.
a. 0.87
b. 0.77
c. 8.7
d. 7.7
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b. Tetrabromophenolpthalein
c. Tetrabromofluorescein
d. Xylenol orange
66. The active fraction of starch which reacts with iodine to form an intense blue color
a. Amylopectin
b. Amylose
c. Glucose
d. Sucrose
67. When a reducing analyte is titrated directly with iodine, the method used is called
a. Iodometry
b. Iodimetry
c. Cerimetry
d. Permanganometry
68. The 0.1 N iodine solution is standardized using
a. Potassium permanganate
b. Potassium hydrogen phthalate
c. Arsenic trioxide
d. Sodium carbonate
69. Iodimetry is an indirect analysis of:
a. Oxidizing agent
b. Reducing agent
c. Acid
d. Base
70. Which of the following statement/s is/are correct according to USP 27?
I. In azeotropic method of water of analysis toluene is used as solvent.
II. In azeotropic method of analysis toluene and xylene are used as solvents.
III. In azeotropic method of analysis toluene, xylene, and water are used as
solvents.
a. I only
b. I and II only
c. I, II, and III
d. None of the statement is correct
71. What weight of arsenic trioxide (93.73%) 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
a. 0.14896 g
b. 0.4896 g
c. 0.1111 g
d. 0.9145 g
72. The type of alkaliodal assay where the total alkaloid is determined.
a. Ultimate
b. Specific
c. Proximate
d. Extraction
73. Which of the following statement/s is/are correct?
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b. 0.067
c. 0.114
d. 0.026
80. Orthophenanthroline TS is used as indicator in
a. Permanganometry
b. Ceric sulfate titration
c. iodometry
d. Iodimetry
81. A sample of Chlorpheniramine maleate weighing 0.502 g was assayed by nonaqueous
titrimetry using 22.2 mL of perchloric acid with normality of 0.1125. Calculate the %
purity of the sample. Each mL of 0.1 N perchloric acid is equivalent to 19.54 mg of
C16H19CLN2. C4H4O4
a. 97.2
b. 72.9
c. 27.9
d. 9.72
82. Calculate the weight of oxalic acid required to prepare 1000 mL of 0.5 N of the solution.
MW = 126
a. 36.5 g
b. 63.5 g
c. 31.5 g
d. 23.5 g
83. If 10g of olive oil required 20 mL of 0.0211 N NaOH in the titration of the free fatty acids.
What is the acid number of the oil?
a. 2.9
b. 2.4
c. 11.50
d. 115
84. Does the acid value of the above conform with the official requirement? (In 10g of olive
oil, the specification is <5mL of 0.1N NaOH.)
a. Yes
b. No
c. Uncertain
d. None of the above
85. In phenol contain determination of a volatile oil, the layer in the graduated neck of the
cassia flask read 2.3 mL obtained from a sample of 10 mL of the oil after treatment with
KOH solution. The % phenol is:
a. 73
b. 69
c. 7.3
d. 77
86. A 4.0570 g sample of chlorinated lime was mixed with enough water to make 1000mL. A
100 mL of the mixture was treated with potassium iodide and acetic acid, then titrated
with 22.4 mL of sodium thiosulfate solution. A 20 mL sample of sodium thiosulfate was
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found to be equivalent to 0.2996 g of pure iodine. Calculate the available chlorine in the
sample.
MW Iodine = 126.9 ; MW Cl = 35.45
a. 27.35%
b. 27.45%
c. 29.02%
d. 23.1%
87. Military standard table is also known as:
a. Government sampling plan
b. MIL-STD-105D
c. ABC-STD 105D
d. All of the choices
88. The % hexane extractive obtained from 27.5820 g of crude drug yielding a residue of
0.9155g of extractive is:
a. 3.32%
b. 33.2%
c. 4.30%
d. 4.6%
89. Calculate the menthyl acetate content in % if 9.5 g sample of peppermint oil was
refluxed with 25 mL of 0.5N alcoholic KOH and required 22.5 ml of 0.4900N HCl for the
residual titration. The blank was run using the same volume of 0.5N alcoholic KOH and
required 26.0mL of 0.4900N HCl to bring about the end point. Each mL of 0.5N alcoholic
KOH consumed in the saponification is equivalent to 99.15 mg menthyl acetate.
a. 4.82%
b. 3.58%
c. 4.80%
d. 8.4%
90. Calculate the % alkaloid extracted from a bark of plant using 1.0215g of the crude drug;
the volume of 0.0245N sulfuric acid added to the extract was 25.7 mL, the excess was
back titrated by 21.75 mL of 0.0225N sodium hydroxide solution. Each ml of 0.02N
sulfuric acid is equivalent to 3.8858 mg of the alkaloid.
a. 2.67%
b. 6.72%
c. 7.62%
d. 6.5%
91. Determine the iodine value of an unknown sample of oil weighing 0.21g if 26mL and 12
mL of 0.1100 N of sodium thiosulfate are required for the blank and residual titration
respectively.
a. 90
b. 93
c. 108
d. 200
92. Identify the sample of the above question with USP requirement of:
a. Persic oil 90-108
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111. The standard substance used in checking the cleanliness of Abbe refractometer
by determining its refractive index is:
a. Rose oil
b. Water
c. Methanol
d. Peanut oil
112. Coulometric Titration of water determination is also known as:
a. Method I c
b. Method II
c. Method I a
d. Method III
113. Perchloric acid in glacial acetic acid and perchloric acid in dioxane are volumetric
solution used in what type of analysis?
a. Direct acidimetry
b. Direct alkalimetry
c. Non-aqueous acidimetry
d. Non-aqueous alkalimetry
114. The primary standard used in the standardization of the above VS is:
a. Sodium carbonate
b. Sodium bicarbonate
c. Potassium biphthalate
d. Benzoic acid
115. Which of the following statement/s is/are true?
I. Phenol is assayed using residual iodometry using excess bromine
solution.
II. 0.1 N Bromine solution contains potassium bromide and potassium
bromate.
III. Bromine vapor is liberated from KBr and KBrO3 in basic environment.
a. I only
b. I and II only
c. I, II, and III
d. None of the choices
116. A 1.5g of liquefied phenol was dissolve in enough water to make 1000mL. A 30
mL sample of the solution was treated with 30 mL of 0.1 N Bromine solution and
HCl. The mixture was treated with KI and titrated with 8.7 mL of 0.1N sodium
thiosulfate. It was also found that 21 mL of 0.1N sodium thiosulfate was required
in the titration of the iodine liberated when 20 mL of the bromine solution was
treated with KI and HCl. Compute for the % phenol in the sample. MW Phenol =
94.
a. 59.4
b. 69.4
c. 79.4
d. 89.4
117. Hydrolysis products of ASA
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c. Colorless
d. Green
126. Assay of zinc oxide is what type of analysis?
a. Alkalimetric residual
b. Acidimetric direct
c. Acidimetric residual
d. Alkalimetric direct
127. The indicator used if weak acid is titrated with strong alkali.
a. Methyl orange
b. Methyl red
c. Phenol red
d. Phenolphthalein
128. Phenolphthalein in alkali medium is colored:
a. Yellow
b. Pink
c. Colorless
d. Blue
129. Suppository that does not melt at body temperature is what kind of defect?
a. Major
b. Critical
c. Minor
d. Performance
130. Performs and evaluate microbiological assay, sterility, pyrogen, and
bacteriological test, safety or acute toxicity test.
a. Material inspection section
b. Analytical laboratory
c. Biological testing
d. Specification and analytical laboratory
131. 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
132. When the alcoholic KOH is used to neutralized the acid and saponify the ester of
1 gram of the oil or fat, the constant determined is:
a. Acid value
b. Ester value
c. Hydroxyl value
d. Saponification value
133. The instrument used to measure the optical activity of the sample is:
a. Refractometer
b. Polarimeter
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c. Spectrometer
d. Flame photometer
134. 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
135. The end point of iodometry using starch TS as indicator is:
a. Intense blue color
b. Disappearance of blue color
c. Greenish-blue color
d. Disappearance of green-blue color
136. Which of the following statement/s is/are correct?
I. Ester value is the number of mg of KOH required to saponify the ester in 1 g of
fat or oil.
II. Ester value = saponification value + Acid value
III. Ester value determination is applicable to fats, volatile oils, and alcohols.
a. I only
b. I and II only
c. I, II, and III
d. All of the statements are incorrect
137. Which of the following area is not a responsibility of quality control manager?
a. Specification and analytical development
b. Biological testing lab
c. Analytical lab
d. Market research
138. Hexane is the best solvent extracting:
a. Resins
b. Fats
c. Volatile oil
d. Acid
139. What is the other name of Koettsdorfer number?
a. Acid value
b. Saponification value
c. Ester value
d. Iodine value
140. The unsaponifiable matter present in animal fats is:
a. Cholesterol
b. Phytosterol
c. Lard
d. Wax
141. The crude fiber of a drug usually consist of:
a. Cellulose
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b. Cholesterol
c. Phytosterol
d. All of the choices
142. The unsaponifiable matter present in vegetable oils and fats is:
a. Cholesterol
b. Cellulose
c. phytosterol
d. lard
143. If a 0.47 g sample of potassium iodide yielded 0.7564 g of silver iodide
precipitate by gravimetric assay, compute for the % purity of the potassium
iodide. MW KI = 165.90; MW AgI = 234.76
a. 83.7%
b. 93.7%
c. 103.7%
d. 113.7%
144. Which of the following volumetric solutions is used in diazotization analysis of
sulfa drugs?
a. 0.1 M sodium nitrite
b. 0.05 edetate disodium
c. 0.01 M sodium nitrite
d. 0.1 N Iodine solution
145. Phenol is assayed using this method of analysis.
a. Residual alkalimetry
b. Volumetric precipitation
c. Residual iodometry using excess bromine
d. Iodimetry
146. 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
a. 0.09196
b. 0.91960
c. 0.21090
d. 0.01209
147. A 0.5110 g sample of sulfathiozole was assayed using 18.8 mL of 0.1005 M
sodium nitrite solution in a titration. Each mL of 0.1 M sodium nitrite is equivalent
to 25.53 mg of C9H9N3O2S2. Calculate the % C9H9N3O2S2 in the sample.
a. 99%
b. 95%
c. 94%
d. 93%
148. Which of the following standard solutions is not used in redox titration?
a. Sodium thiosulfate solution
b. Iodine solution
c. Bromine solution
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157. Calculate the water content of streptomycin powder using 3.50 g sample. The
water equivalence factor, F, of the KF reagent was 4.6 and the volume
consumed was 9.2 mL. The % water content was:
a. 1.20
b. 1.21
c. 12.10
d. 1.10
158. Twenty tablets of Ascorbic acid weighed 4.250 g and a powdered sample of
0.3075 g used up 21.5 mL of 0.1085 N iodine solution. What was the amount of
Ascorbic acid per dose of 2 tablets? Each mL of 0.1 N iodine is equivalent to 8.80
mg of C6H6O6 (Ascorbic Acid). The amount is:
a. 283.7 mg
b. 141.86 mg
c. 0.2836 g
d. A and C
159. The primary staining reagent of the Gram procedure is:
a. Methyl red
b. Carbol fucshin
c. Crystal violet
d. Saffranin
160. The bacterial structure responsible for selective permeability is:
a. Cell wall
b. Fimbriae
c. Spore
d. Cytoplasmic membrane
161. The measurement of a base of a given sample by titration with the standard acid
is:
a. Acidimetry
b. Alkalimetry
c. Complexometry
d. Redox
162. Analysis where separation of the constituent from the sample is done that
weighing the products is:
a. Volumetric
b. Gravimetric
c. Special
d. Gasometric method
163. Adsorption indicators are used in:
a. Complexometric reaction
b. Acidimetry
c. Volumetric precipitation
d. Alkalimetry
164. Titer is an expression of concentration in terms of:
a. g of solute per 100 mL
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b. g or mg of solute per mL
c. g per liter
d. A and C
165. Iodimetry is what type of titration?
a. Direct
b. Indirect
c. Residual
d. A and C
166. The type of alkaloidal assay where the total alkaloids are determines is:
a. Ultimate
b. Specific
c. Proximate
d. Precision
167. To measure optical activity of a sample, the instrument used is:
a. Polarimeter
b. Refractometer
c. Spectrometer
d. Flame photometer
168. The indicator for EDTA titration against CaCO3 is:
a. Thymol blue
b. Hydroxynapthol blue
c. Methyl red
d. Methylene blue
169. In neutralization methods in aqueous medium, a product is:
a. Oil
b. Salt
c. Precipitate
d. A and B
170. The moisture content of a drug maybe:
a. Water of hydration
b. Water in the adsorbed form
c. Water of crystallization
d. All of the above
171. The oxidation number of atomic iodine is:
a. +1
b. +2
c. +4
d. +3
172. A spectrophotometer differs from a colorimeter is that it consists of:
a. Prism
b. Lamp house
c. Cell compartment
d. B and C
173. The ash content of an organic compound is an impurity of:
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a. Prism
b. Lamp house
c. Oil
d. Volatile oil
174. To keep samples moisture-free the apparatus used is:
a. Desiccator
b. Furnace
c. Incubator
d. Oven
175. Microbial assay of an antibiotics maybe performed using the following except:
a. Test tube inoculation
b. Cylinder plate method
c. Paper disk method
d. Titration process
176. Result of the experiment that are close to one another is considered to be:
a. Accurate
b. Cylinder plate method
c. Approximate
d. A and C
177. Flame Spectroscopy procedures maybe divided into:
a. Flame emission
b. Atomic adsorption
c. Nuclear magnetic resonance
d. A and B
178. Safety and Toxicity test are conducted using:
a. Rabbits
b. Dogs
c. White mice
d. Guinea pig
179. A parenteral is declared pyrogenic if the temperature rise in rabbits is:
a. Less than 1.4°C in the 9 readings of the 3 rabbits
b. 0.6°C in in the 1 of the 9 readings
c. >1.4°C in the 9 readings of the 3 rabbits
d. None of the above
180. The ester value determination of substance is applicable to the following except:
a. Fats
b. Volatile oil
c. Alcohols
d. Fatty oils
181. In Gas chromatography, the results of the assay is expressed in:
a. Retention on the column
b. Rf value
c. Volume of the gas used
d. Adsorbent
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182. The process by which the exact concentration of a solution is determined by:
a. Neutralization
b. Standardization
c. Hydration
d. Titration
183. The infrared region of the spectrometer used to identify a substance uses a
wavelength range of:
a. 3-5 µm
b. 380-780 µm
c. 200-380 µm
d. 15-300 µm
184. The primary standard used to standardize Karl Fischer reagent is:
a. Sodium carbonate anhydrous
b. Potassium biphthalate
c. sodium tartrate dihydrate
d. sodium bicarbonate
185. the molecular weight of sulfuric acid is 98. Its equivalent weight is:
a. 98
b. 49
c. 0.098
d. 0.049
186. The type of ash where sulfuric acid used to whiten the ash is:
a. acid insoluble ash
b. sulfated ash
c. loss on ignition
d. ROI
187. The oil from peppermint can be determined by using:
a. Cassia flask
b. Bobcock bottle
c. Pycometer
d. Titration
188. 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?
a. 20
b. 30
c. 40
d. 60
189. Using spectrophotometer to measure the concentration of a sample, the following
data were obtained: absorbance (A) of the standard solution was 0.55. A of the
sample was 0.58. Concentration of the standard used was 16.5 mcg. The
concentration of the sample was:
a. 15.5 mcg
b. 17.55 mcg
c. 17.40 mcg
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d. 15.9 mcg
190. Nephelometry is based on the measurement of light that is ______ by the
particles of a suspension.
a. Reflected
b. Absorbed
c. Transmitted
d. Absorbed
191. The type of chromatography where the cellulose of the filter paper is used as the
adsorbent is:
a. Column
b. Paper
c. TLC
d. Gas
192. All of the following are optical devices except:
a. pH meter
b. Spectrophotometer
c. Colorimeter
d. Filter photometer
193. Which of the following is an oxidizing agent?
a. Ascorbic acid
b. KMnO4
c. Sodium thiosulfate
d. Sodium nitrite
194. A method used to assay Vitamin B12 and Ca panthothenate is by:
a. Iodimetry
b. Micro-bio/ turbidimetric
c. Fluorometry
d. Iodometry
195. The assay of aldehyde content in volatile oil may be by:
a. Gravimetric
b. Bisulfite
c. Hydroxylamine
d. B and C
196. One of the fundamental laws in spectroscopy is:
a. Law of mass action
b. Beer’s law
c. Boyle’s law
d. Newton’s law
197. Gas chromatography is utilized in the separation of:
a. Volatile component in a liquid mixture
b. Amino acids
c. Blood components
d. A and B
198. In column Chromatography, the separation of the sample mixture into a series of
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c. Both a and b
d. None of the above
214. The classification plastic materials intended for use as a container of drug
products is
determined through what type of test?
a. Biological Reactivity Test, In Vitro
b. Biological Reactivity Test, In Vivo
c. Both a and b
d. None of the above
215. Plastic materials which comply with the requirements of Biological Reactivity
Test, In Vitro are essentially?
a. Non cytotoxic
b. Non carcinogenic
c. Both a and b
d. None of the above
216. The conductivity of water is expressed in what unit?
a. µS/cm
b. µS/cm2
c. µmho2/cm
d. None of the above
217. The acceptable pH level of water used for pharmaceutical compounding is
a. Between 6.0 and 7.0
b. Between 5.0 and 7.0
c. Between 7.0 and 8.0
d. None of the above
218. In the manufacture of sterile parenteral solutions all added raw materials must be
sterile.
a. Necessary
b. Not necessary
c. Always
d. None of the above
219. A large volume intravenous solution has a minimum volume of
a. 1000mL
b. 200mL
c. 500mL
d. None of the above
220. A small volume of intravenous solution has a maximum volume of
a. 1000mL
b. 200mL
c. 500mL
d. None of the above
221. A sterile parenteral solution is also non pyrogenic
a. All the time
b. Most of the time
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c. Sometime
d. Not at all
222. If the bacterial endotoxin limit of a dosage form is 0.25EU/mL it means all
components of the preparations shoul contribute
a. ≤ 0.25EU/mL
b. ≥0.25EU/mL
c. <0.25EU/mL
d. None of the above
223. Finished product sterilization by autoclaving will destroy pyrogens in the
preparation
a. All the time
b. Most of the time
c. Sometime
d. Not at all
224. Sterility Testing of Pharmacopeial articles test for the presence of
a. Gram (+) and gram (-) organism
b. Aerobic and anaerobic organism
c. Both a and b
d. None of the above
225. Long term stability testing of pharmaceutical articles is carried out at
a. 23 ± 2°C, 60 ± 5% RH
b. 25 ± 2°C, 60 ± 5% RH
c. 20 ± 2°C, 60 ± 5% RH
d. None of the above
226. Accelerated stability testing of pharmaceutical articles at controlled room
temperature
conditions is carried out at
a. 30 ± 2°C, 75 ± 5% RH
b. 35 ± 2°C, 75 ± 5% RH
c. 40 ± 2°C, 75 ± 5% RH
d. None of the above
227. The minimum time period covered by the data for long term stability studies is
a. 6 months
b. 12 months
c. 18 months
d. None of the above
228. The minimum time period covered by the data for accelerated stability studies is
a. 6 months
b. 12 months
c. 18 months
d. None of the above
229. Long term stability testing of pharmaceutical articles stored in a refrigerator is
carried
out at
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a. 5 ± 3°C
b. 8 ± 3°C
c. 4 ± 3°C
d. None of the above
230. Stability indicating test procedures include
a. Antimicrobial effectiveness test
b. Dissolution test
c. All of the above
d. None of the above
231. A sterilizing filter has a pore size of
a. 0.5 µm
b. 0.2 µm
c. 1 µm
d. None of the above
232. The reference microorganism for testing the retention efficiency of a sterilizing
filter is
a. Pseudomonas aeruginosa
b. Pseudomonas diminuta
c. E. coli
d. None of the above
233. Autoclaving or Steam Sterilization should be validated to ensure that the
likelihood of survival of the most resistant microorganism is no greater than
a. 10 -5
b. 10 -6
c. 10 6
d. 10 5
234. What is the time (in minutes) required to reduce the microbial population by 90%
or 1 log cycle (i.e., to a surviving fraction of 1/10), at a specific temperature.
a. Sterilization time
b. D value
c. F0
d. None of the above
235. What is the time (in minutes) required to provide the lethality equivalent to that
provided at 121° for a stated time. 10% at any wavelength in the range from 290
to 450 nm.
a. Sterilization time
b. D value
c. F0
d. None of the above
236. A passing tablet friability result is a maximum weight loss of not more than what
percent of the weight of the tablets being tested.
a. 2%
b. 5%
c. 1%
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c. Volumeter
d. Baffle box
261. One of the following is NOT an in-process control for tablet:
a. Bioavailability
b. Hardness and thickness
c. Weight variation
d. Disintegration
262. Pyrogen test is performed in:
a. Pigeons
b. Mice
c. Rabbits
d. Guinea pigs
263. Which is the following statements is NOT true about closure:
a. Should fit the thread of the containers
b. Should produce no leaks
c. Should be made of plastic materials
d. Should be reasonably tight and look elegant
264. Friability testing is done using a Roche friability that must be set to ensure:
a. 10 falls of tablets
b. Either A or B
c. 100 falls of tablets
d. 100 rpm
265. Evaluation of Aspirin Granules (IPQC)
Weight of the sample = 50 grams
Height of cone formed (fixed funnel) = 5 cm
Diameter of cone formed = 13 cm
The repose angle is
a. 25°
b. 38°
c. 30°
d. 50°
266. The temperature wherein the refrigerator is thermostatically maintained is:
a. 36°F and 46°F
b. 46°F and 59°F
c. -13°F and 14°F
d. -23°F and 34°F
267. Water attack test as an official test for glass is done on:
a. Type I glass
b. Type II glass
c. A and B
d. Type III glass
268. Content uniformity test is initially conducted in:
a. 10 tablets
b. 20 tablets
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c. 15 tablets
d. 5 tablets
269. Content uniformity test is used to ensure which of the following quality in tablet
products:
a. Disintegration
b. Purity
c. Bioavailability
d. Potency
270. 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
271. Common component of cap liners, stoppers, and parts of dropper assemblies:
a. Metal
b. plastic
c. Glass
d. Rubber
272. This class of drugs require batch certification from the Bureau of Food and Drugs
a. Anti-convulsants
b. Antibiotics
c. analgesic
d. Vitamins
273. While waiting for its release by the quality control, materials are held in:
a. Packing area
b. Quarantine area
c. Analytical laboratory
d. Biological laboratory
274. One of the following is a secondary packaging component:
a. Caps
b. Corrugated cartons
c. vials
d. Bottles
275. A test which is determined by selecting not less than 30 tablets from each
production batch and assaying 10 tablets individually as directed in the assay
of the individual compedial monograph.
a. Content uniformity
b. Weight variation
c. Disintegration test
d. Dissolution test
276. The gas that is used in gas sterilization is:
a. Oxygen
b. Ethylene oxide
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c. Carbon dioxide
d. Nitrogen
277. The bioassay for Parathyroid Injection is based on measuring the increase in
serum calcium in
a. Cat
b. Dog
c. Sheep
d. Rat
278. Biological reactivity test(s) in vitro except
a. Agar diffusion test
b. Direct contact test
c. Implantation test
d. Elution test
279. Animal employed for the biological assay of oxytocin injection
a. Pigeon
b. Rabbit
c. Chicken
d. Rat
280. Bleeding is a main stability problem seen in
a. Capsules
b. Emulsions
c. Ointments
d. Tablets
281. The test for content uniformity is required for
a. Film-coated tablets
b. Solutions for inhalation
c. suspensions
d. Liquid-filled soft capsules
282. Powdered glass test is done on the following except
a. Borosilicate glass
b. Soda lime glass
c. Treated soda lime glass
d. General purpose soda lime glass
283. In what type of dosage form is the determination of zeta potential needed?
a. Suspensions
b. Solutions
c. emulsions
d. Aerosols
284. Determine the shelf-life of a product
a. Sampling inspection program
b. Validation program
c. Stability testing program
d. All
285. The QC manager is not in charged of this section
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a. Analytical laboratory
b. Biological testing laboratory
c. Specs and analytical program
d. Research and development section
286. The dye used in the leaker test
a. Methylene blue
b. Phenolphthalein
c. Thymol blue
d. None of the above
287. A defect that may affect the function of an object and therefore, may render the
product useless.
a. Major defect
b. Critical defect
c. Minor defect
d. Ocular defect
288. A firm’s removal or correction of a distributed product which involves no violation
a. Drug recall
b. Market withdrawal
c. Stock recovery
d. None of the above
289. Which question is used to predict the shelf life of a drug product?
a. Michaelis-Menten equation
b. Arrhenius theory
c. Hixson-Crowell equation
d. Stokes equation
290. 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 method
d. Analytical laboratory
291. Pyrogen test in vitro:
a. Colorimeter
b. Cylinder-plate method
c. Fluorophotometer
d. LAL method
292. Potency of a 100 mg tablet at expiry date:
a. 95 mg
b. 90 mg
c. 105 mg
d. 110 mg
293. A critical defect that would stop the packaging line operations:
a. Wrong labels
b. Misaligned labels
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c. Inverted labels
d. smeared labels
294. Standard Operating Procedures (SOP):
a. Concerned with record keeping
b. Step by step method on how to go about a job
c. Done to facilitate recall
d. All of these are correct
295. Samples of raw materials in the quarantine area will not be subjected to this test:
a. Physical and organoleptic examination
b. Leaker test
c. Potency assay
d. Microbiological test
296. It is the partial or complete separation of the top or bottom of a tablet from the
main body
a. Lamination
b. Capping
c. Mottling
d. Picking
297. The round bottom flask used for the dissolution rate in the evaluation of tablets
should be submerge in constant temperature water bath maintained at what
temperature.
a. 37°C
b. 25°C
c. 40°C
d. 30°C
298. The type of container which is impervious to air or any other gas under the
ordinary or customary conditions of handling, shipping, storage and distribution.
a. Tight-container
b. Well-closed container
c. Single-unit container
d. Hermetic container
299. The word GITS as a drug delivery system means
a. Gastro-intestinal tract system
b. Gastric infection treatment support
c. Gastro-intestinal therapeutic system
d. General internal therapeutic system
300. The temperature used for ignition to constant weight is:
a. 725 ± 25°C
b. 800 ± 25°C
c. 825 ± 25°C
d. 750 ± 25°C
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