Professional Documents
Culture Documents
Page 1 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
10. Describes how close a measured value is to the true value.
a. Accuracy
b. Precision
c. Range
d. Standard deviation
11. Primary standard in the standardization of perchloric acid
a. Potassium hydrogen phthalate
b. Calcium carbonate
c. Benzoic acid
d. Sodium carbonate
12. Primary standard in the standardization of sodium methoxide.
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
d. All of the choices
e. C only
14. Other name of systematic error
a. Determinate
b. Indeterminate
c. Random
d. Both b and c
15. Ferric ammonium sulfate is used as indicator in the standardization of:
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
17. Limit moisture in nonaqueous titrimetric analysis is less than:
Page 2 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
a. 0.5 %
b. 0.05 %
c. 0.2 %
d. 0.02 %
18. Complete reaction: H2C4H4O6 + NaOH -
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
b. Chloroform
c. Thymol
d. Sodium carbonate
21. Standard solution in non-aqueous titrimetric analysis-acidimetry
a. perchloric acid
b. hydrogen bromide
c. both a and b
d. none of the choices
22. Standards solutions are also known as:
a. test solutions
b. volumetric solutions
c. saturated solution
d. none of the choices
23. If starch is used as an indicator, the end point is/are:
a. appearance of intense blue color
b. disappearance of intense blue color
c. both of the choices
d. none of the choices
24. Types of chemical reaction used in the volumetric analysis
a. redox
b. neutralization
c. diazotization
d. all of the choices
e. a and b only
25. Use of KI in the preparation of iodine solution.
a. Solubilizing agent
b. Change in pH of the solution
Page 3 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
c. As preservative
d. All of the choices
26. Other name of ferrous phenanthroline.
a. eosin Y
b. crystal violet
c. ferroin
d. ferric alum
27. Color of the complex resulting from reaction with ferrous phenanthroline:
a. blue
b. red
c. pink
d. violet
28. Primary standard in the standardization of ceric sulfate solution
a. potassium hydrogen phthalate
b. calciuim carbonate
c. sodium bicarbonate
d. arsenic trioxide
29. In the standardization of iodine solution, why is there a need to boil the solution of
arsenic trioxide?
a. it increases the solubility
b. it makes the solution stable
c. both a and c
d. none of the choices
30. Indicator in iodometric method of analysis.
a. KMnO4
b. Methyl red TS
c. Methyl orange TS
d. Starch TS
31. A molecule which provides groups of attachment to metal ions.
a. Ligand
b. Chelate
c. Both a and b
d. None of the choices
32. HCl + Calcium carbonate will react to form a primary product known as:
a. Carbonic acid
b. Calcium hydroxide
c. Both a and c
d. None of the choices
33. The reaction between HCl and calcium carbonate can be seen in the standardization of:
a. Silver nitrate
b. Ammonium thiocyanate
c. Edetate disodium
d. Sulfuric acid
34. A substance which gains electrons in a redox reaction.
Page 4 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
a. Oxidizing agent
b. Reducing agent
c. Both a and c
d. None of the choices
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
36. NaCl ______ the stability of EDTA complex.
a. Increases
b. Decreases
c. No effect
d. None of the choices
37. Organic solvents _______ the stability of EDTA complex.
a. Increases
b. Decreases
c. No effect
d. None of the choices
38. Indicator in Redox Titration using KMnO4
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
40. Most suitable indicator to use in titration of organic acids
a. Methyl red TS
b. Methyl orange TS
c. Phenolphthalein
d. All of the choices
41. Which of the following statement/s is/are correct?
I. Non-aqueous alkalimetry is used when the analyte is weakly acidic
II. Non-aqueous alkalimetry is used when analyte is acid halide.
III. Non-aqueous alkalimetry is used when the analyte contains heterocyclic nitrogen
compound.
IV. Non-aqueous alkalimetry is used when analyte is barbiturate.
a. I only c. I, II, and III only
b. I and II only d. I, II, and IV
42. Indicator/s used in nonaqueous titrimetry
Page 5 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
I. Nile blue
II. Crystal violet
III. Malachite green
IV. Phenolphthalein
a. I only c. I, II, and III only
b. I and II only d. I, II, III and IV
43. Standard solutions in nonaqueous alkalimetry.
I. Lithium methoxide
II. Perchloric acid
III. Hydrogen bromide
IV. Sodium hydroxide
a. I only c. I, II, and III only
b. I and II only d. I, II, III and IV
44. The use of chloroform in sodium thiosulfate solution.
a. To stabilize the solution
b. To increase its solubility
c. To prevent bacterial growth
d. To maintain pH of the solution
45. Which of the following statement/s is/are correct?
I. The utility of starch as indicator is reduced in the presence of organic solvent.
II. The utility of starch as indicator is reduced in the presence of electrolytes.
III. The utility of starch as indicator is reduced at temperature above 25 C
IV. The utility of starch as indicator is reduced at temperature of 25C.
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
d. No indicator is suggested
47. The formula to compute the equivalent weight of a reducing agent.
a. Molecular weight/ no. of electrons gain
b. Molecular weight/ no. of electrons loss
c. Both a and b
d. None of the choices
48. The used of sodium bicarbonate in the standardization of iodine solution ______.
a. Increase the solubility
b. as buffer
c. As preservative
d. To prevent bacterial growth
49. Method/s determining the total nitrogen in a sample
Page 6 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
Page 7 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 8 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
63. What is the use of HgI2 in the preparation of starch TS?
a. To increase the solubility of starch
b. To impart color
c. As a preservative
d. To stabilize the pH
64. Process of measuring the actual quantity mass, volume, force, etc. that correspond to an
indicated quantity on the scale of an instrument.
a. Weighing
b. Calibration
c. Both a and c
d. None of the choices
65. Also known as Eosin Y.
a. Dichlorofluorescein
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.
Page 9 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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?
I. Method I of water content determination in USP 27 is the azeotropic
toluene distillation method.
II. Method II of water content determination in USP 27 is the titrimetric
method.
III. Method III of water content determination in USP 27 is the gravimetric
method.
IV. Method I of water content determination in USP 27 is the Karl Fischer
method.
a. I only
b. II only
c. III only
d. IV only
74. Residue on ignition is also called:
a. Loss on ignition
b. Loss on drying
c. Acid-soluble ash
d. Sulfated ash
75. Primary standard used to standardized Karl Fischer reagent is:
a. Anhydrous sodium carbonated
b. Sodium tartrate
c. Potassium hydrogen phthalate
d. Sodium oxalate
76. Method 1 for determining alcohol-soluble extractives is also known as:
a. Hot extraction method
b. Cold extraction method
Page 10 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 11 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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%
Page 12 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
b. Corn oil 102-128
c. Olive oil 79-88
d. None of the choices
93. Find the acid value of oleic acid sample weighing 2g which require 45mL 0f 0.1102
NaOH to bring about the end point.
a. 196
b. 200
c. 345
d. 139
94. If a sample of white wax is found to have an ester value of 65.7 and a saponification
value of 74.2, what is the acid value of the sample?
a. 8.5
b. 86.5
c. 186.5
d. 56.5
95. A 50 mL aliquot of solution containing .450g of magnesium sulfate in 0.5L required 37.6
mL of EDTA solution for titration. How many mg of calcium carbonate will react with 1
mL of this EDTA solution? MW magnesium sulfate = 120.37; MW CaCO3 = 100
a. 0.9943 mg
b. 9.99 mg
c. 99.94 mg
d. 9943 mg
96. The following is/are true about auxillary complexing agent.
I. Eriochrome black is an example of an auxillary complexing agent
II. Auxillary complexing agents are also ligands
Page 13 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
III. Auxillary complexIng agents binds the metal strong enough to prevent the
hydroxide from precipitating, but weakly enough to give up the metal ion when
EDTA is added.
IV. It is used to permit many metals to be titrated in alkaline solution with EDTA.
a. I only
b. II and III
c. II, III, and IV
d. III, and IV
e. I, II, III and IV
97. The following is/ are true about EDTA titration.
I. EDTA titration is also known as complexometric titration.
II. The equilibrium constant in EDTA titration is called EDTA indicator.
III. For end-point detection, commonly used indicator is called EDTA indicator
IV. EDTA titration technique includes displacement titration.
a. I only
b. II and III
c. I, II, and III
d. I, II and IV
e. I, II, III and IV
98. Which of the following statement/s is/are true?
I. A redox indicator is a compound that changes color when it goes from oxidized to
reduced state
II. Starch is a redox indicator
III. Ferroin is a redox indicator
IV. The hydrolysis is product of starch is glucose which is a reducing agent
a. I only
b. I and II
c. III, I, II, and III
d. I, III, and IV
e. I, II, III, and IV
99. Which of the following statement/ is/are correct?
I. KMnO4 can be standardized using arsenic trioxide
II. KMnO4 serves as indicator in acidic solution.
III. Hydrogen peroxide can be analyzed using KMnO4.
IV. KMnO4 in acidic solution is reduced to colorless Mn+2
a. I and II
b. I, II, and III
c. II, III, and IV
d. II and IV
e. I, II, III and IV
100. Which of the following statements is/are correct?
I. Potassium dichromate is an oxidizing agent
II. Potassium dichromate is used chiefly for the determination Fe+2 and indirectly
sample that will oxidized Fe+2 to Fe+3.
Page 14 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 15 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
b. Potassium phthalate
c. Sodium oxalate
d. Tromethamine
108. Method II of determining iodine value is also known as:
a. Hubs method
b. Wijs method
c. Hanus method
d. All of the choices
109. Residual titration method is also known as:
a. Direct titration
b. Indirect titration
c. Back titration
d. Redox titration
110. To determine the total ash, the sample is incinerated at a temperature of 675 + -
25C. This temperature is represented by:
a. Very dull heat
b. Dull red heat
c. White red heat
d. Bright red heat
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.
Page 16 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 17 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
122. Which of the following chemicals is not included in preparing the Karl Fischer
reagent?
a. Pyridine
b. Acetone
c. Sulfur dioxide
d. Iodine
123. The process in which the exact concentration of solution is determined.
a. Neutralization
b. Standardization
c. Titration
d. Complexation
124. Titer is an expression of concentration of solution is determined.
a. g of solute/ 100 mL
b. g or mg/mL
c. g of solute / L
d. b and c
125. Methyl orange in base medium is colored:
a. Yellow
b. Pink
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
Page 18 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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
Page 19 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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
Page 20 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
d. Sodium hydroxide solution
149. Assay of ASA (raw material) is an example of what method of analysis?
a. Direct alkalimetry
b. Residual alkalimetry
c. Direct acidimetry
d. Residual acidimetry
150. Assay of sodium nitrite is an example of what method of analysis?
a. Direct titration Redox
b. Indirect titration Redox
c. Residual titration Redox
d. Iodimetry
151. 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. Pharmacopeial testing
d. Pharmaceutical assaying
152. Two substances reacting upon reaching the end point must have the same
a. Normality
b. Volume
c. Number of mEq
d. Weight
153. Most of the official drugs containing Calcium and Magnesium are determine by:
a. Gravimetric
b. Complexometry
Page 21 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
c. Bioassay
d. Non-aqueous matter
154. Type of titration used in volumetric analysis:
a. Direct
b. Residual
c. Indirect
d. All of the above
155. The iodine value of an oil is a quantitative measure of:
a. Phenol coefficient
b. Saturated fatty acid
c. Unsaturated fatty acid
d. Unsaponifiable matter
156. A sample of 0.1350 g of As2O3 was assayed iodimetrically using 23.4 mL of
0.1055 N iodine solution (atomic weight: As=74.92, O=16) The percentage purity
of the sample is:
a. 90.44
b. 90.23
c. 89.0
d. 90.54
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
Page 22 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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
Page 23 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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:
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:
Page 24 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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 1.4C in the 9 readings of the 3 rabbits
b. 0.6C in in the 1 of the 9 readings
c. >1.4C 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
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 m
b. 380-780 m
c. 200-380 m
d. 15-300 m
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
Page 25 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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
Page 26 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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. Beers law
c. Boyles law
d. Newtons 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
narrow bands in a column is called:
a. Chromatogram
b. Eluent
c. Development
d. A and B
199. In spectrometry, when a test solution is prepared and observed identically with a
reference standard, they are called:
a. Isomeric substance
b. Similar solutions
c. Similar preparations
d. B and C
200. Beers plot in spectrometry is prepared to determine:
a. Absorbance of the sample
b. Wavelength to be used
c. Blank
d. Concentration of the drug substance
201. A one percent (1%) solid in liquid solution is officially (USP) understood as:
a. 1g in 100 mL
b. 100 mg in 1 mL
c. 10g in 1000 mL
d. 10 g in 1 L
202. When packaging and storage requirements specifies a well close container it is
understood that;
a. Contents are protected from extraneous solids
b. Contents are protected from extraneous solids and liquids
Page 27 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 28 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
c. Type III
d. NP
211. The type of glass most suitable for parenteral preparation is
a. Type I
b. Type II
c. Type III
d. NP
212. An amber glass bottle for an oral syrup preparation is considered light resistant if
it
allows not more than what percent of light to be transmitted?
a. 10% at any wavelength in range from 290 to 450 nm
b. 15% at any wavelength in range from 290 to 450 nm
c. 20% at any wavelength in range from 290 to 450 nm
d. 25% at any wavelength in range from 290 to 450 nm
213. The suitability of 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
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. S/cm
b. S/cm2
c. mho2/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
Page 29 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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 2C, 60 5% RH
b. 25 2C, 60 5% RH
c. 20 2C, 60 5% RH
d. None of the above
Page 30 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 31 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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%
d. None of the above
237. A tablet friability apparatus also test the friability of this dosage form
a. Soft gelatin capsule
b. Hard gelatin capsule
c. Liquid fill capsule
d. None of the above
238. Disintegration is an essential attribute of this dosage form
a. Plain coated tablet
b. Hard gelatin capsule
c. Chewable tablet
d. All of the above
239. What tablet attribute is correlated with the biological availability of the active
ingredient.
a. Disintegration
b. Dissolution
c. Content uniformity
d. None of the above
240. A belonging to climatic zone IV is officially described as
a. Temperate
b. Hot, humid
c. Hot, dry
d. None of the above
241. The Philippines belong to what climatic zone
a. I
Page 32 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
b. II
c. III
d. None of the above
242. Which of the following is not an official hard gelatin capsule size for human
consumption
a. 000
b. 00 mL
c. 0000
d. None of the above
243. A calibrated volumetric apparatus was calibrated using standards traceable to
a. ASTM
b. ATCC
c. NIST
d. None of the above
244. Pharmaceutical articles like raw materials must not harbor these organism
except.
a. Staphylococcus aureus
b. Pseudomonas aeruginosa
c. Salmonella
d. None of the above
245. The units of osmolar concentration are usually expressed as
a. mOsM
b. mOsm
c. mOSm
d. none of the above
246. Clean room classification are specified in Federal standard
a. 211E
b. 210E
c. 209E
d. None of the above
247. Air particle counts in clean rooms is base on what particle size
a. 0.5 m
b. 0.2 m
c. 1 m
d. None of the above
248. The level in microbiological environmental monitoring is that level of
microorganism that shows a potential drift from normal operating procedure.
a. Alert level
b. Action level
c. Both a and b
d. None of the above
249. In validation procedures the closeness of test results obtained by that method to
the true value is called
a. Precision
Page 33 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
b. Accuracy
c. Specificity
d. None of the above
250. In validation procedures, what is the degree of agreement among individual test
results when the method is applied repeatedly to multiple sampling of a
homogeneous sample.
a. Precision
b. Accuracy
c. Specificity
d. None of the above
251. Which is not a method of neutralizing the antimicrobial properties of a product
a. Neutralization by chemical inhibition
b. Neutralization by dilution
c. Neutralization by sterilization
d. None of the above
252. Which is not a biological indicator in the validation of a moist heat sterilization
a. Bacillus stearothermophilus
b. Bacillus subtilis
c. Bacillus coagulans
d. None of the above
253. Which is the following is not a terminal sterilization procedure
a. Steam sterilization
b. Sterilization by filtration
c. Dry heat sterilization
d. None of the above
254. In validation procedures the ability to assess unequivocally the analyte in the
presence of components that may be expected to be present is called
a. Precision
b. Accuracy
c. Specificity
d. None of the above
255. In analytical methods, the measure of its capacity to remain unaffected by small
but deliberate variations in method parameters and provides an indication of its
reliability during normal usage is called.
a. Linearity
b. Robustness
c. Ruggedness
d. None of the above
256. The following are tablet properties necessary to withstand the mechanical shocks
of manufacture, packaging and shipping EXCEPT
a. Hardness
b. Resistance to weight loss
c. Resistance to friability
d. Disintegration
Page 34 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 35 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
Page 36 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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
Page 37 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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 firms 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
Page 38 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
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
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. 37C
b. 25C
c. 40C
Page 39 of 40
Quality Control and Quality Assurance Questions [PINK PACOP]
d. 30C
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 25C
b. 800 25C
c. 825 25C
d. 750 25C
Page 40 of 40