Drug Quality Control Page 1 of 15

A 1. Most of the official drugs containing calcium and zinc are assayed by:
A) EDTA method B) Gravimetry C) Nonaqueous titrimetry D) Acidimetry

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

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

A 3. Limulus ameobocyte lysate (LAL) assay method is applicable in the determination of:
A) Pyrogens B) Chemical impurities C) Microorganisms D) All of the above

A 4. The measurement of a base of a given sample by titration with a standard acid is:
A) Acidimetry B) Compleximetry C) Alkalimetry D) Redox

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

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

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

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

C 7. A common sampling plan that uses master tables to interpret the results:
A) 100% inspection B) Square root system C) Military standard D) A and C

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

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

A 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

C 10. A tool for detecting variations in a process:

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

D 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

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

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

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

A) Specification and assay development C) Research and development studies
B) Analytical testing laboratory D) Biological testing

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

A) Assures that the oldest stock is used first
B) Prevents contamination and mix-ups of materials
C) Contains the information regarding the activity of the active ingredient
D) All of the above

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

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

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

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

D 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

B 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

C 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

B 20. The molecular weight of NaOH is 40. How many grams of NaOH pellets are needed to make 500mL of 1.5N
solution?
A) 20 B) 30 C) 40 D) 60

B 21. If 1mL of HCl is equivalent to 1.5mL of 0.5N NaOH, the volume of the alkali that would be consumed by 30mL of
acid is:
A) 4.5mL B) 45mL C) 20mL D) 30mL
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A 22. The most effective chemical substance in removing stains of potassium permanganate:
A) Oxalic acid B) Sodium thiosulfate C) Chalk D) Vinegar

C 23. The ester value determination of substances is applicable to the following, except:
A) Fats B) Volatile oils C) Alcohols D) Fatty oils

C 24. The following are indicators used for acid-base titrations, except:
A) Methyl orange B) Phenolphthalein C) Ferric alum D) Methyl red

A 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%

B 26. Residual method titration with EDTA is applicable to what metal ion:
A) Calcium B) Aluminum C) Zinc D) Magnesium

C 27. Chemical reactions that involves a change in the valence number of reacting substances:
A) Neutralization B) Complexation C) Oxidation-reduction D) Precipitation

C 28. A process wherein the sample is made to liberate iodine, which is then titrated with a standard solution of sodium
thiosulfate:
A) Volumetric titration B) Back titration C) Iodometry D) Iodimetry

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

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

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

A) Indirect permanganate oxidation method C) Alkalimetry
B) Direct permanganate oxidation method D) Acidimetry

A 31. Iodometry is an indirect analysis of:

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

A 32. The unsaponified matter present in animal fat is:

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

A 33. The bisulfite method is used in the assay of volatile oils to determine:
A) Aldehyde content B) Acid content C) Ester content D) Sulfur content

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

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

A 35. In phenol content determination of a volatile oil, the layer in the graduated neck of the Cassia flask reached 2.7mL
obtained from a sample of 10mL after treatment with KOH solution. The percentage of oil is:
A) 73% B) 69% C) 7.3% D) 27%

D 36. This determines the shelf life of a product:

A) Sampling inspection program C) Validation program
B) All of the answers D) Stability testing program

B 37. Amount of dissolved drug can be determined by:

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

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

A) Atomic Absorption Spectrophotometer C) Gas Liquid Chromatography
B) UV-Vis Spectrophotometer D) High Pressure Liquid Chromatography

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

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

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

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

A 41. In the microbial assay of antibiotics, the microorganism used for Penicillin G is:
A) Staphylococcus aureus C) Escherichia coli
B) Pseudomonas aeruginosa D) Bacillus subtilis

C 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.
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C) A and B are correct
D) A and B are incorrect

A 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%

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

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

A 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

D 46. Factors that can be manipulated to accelerate instability:

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

D 47. Cross-examination and mix up can happen in the following situations, except:
A) Improperly dispensed components
B) Wrong labels
C) Improper partitioning of production area
D) Components are kept in tightly-sealed containers

A 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

D 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

C 50. Total quality means:

A) Production is responsible for quality C) Quality is everybody’s business
B) Quality combines strict adherence to standard D) All of the above

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

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

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

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

C 53. An analyst who determines the strength, potency and percentage purity of a drug or pharmaceutical product is
performing:
A) Special method B) Identification test C) Pharmaceutical assaying D) Pharmacopoeial test

D 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

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

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

D 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

C 57. Adsorption indicators are used in:

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

D 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

C 59. The indicator used in permanganate titration:

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

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

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

B 61. Volatile oils are complex compounds composed of the following, except:
A) Phenols B) Fatty acids C) Hydrocarbons D) Aldehydes

D 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

C 63. Safety or toxicity test for infusion plastic sets is conducted using:
A) Rabbits B) Dogs C) White mice D) Guinea pigs
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B 64. In IR spectrometry, the finger print region is:
A) Near IR B) Medium IR C) Far IR D) A and B

A 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

C 66. The type of chromatography where the cellulose of the filter paper is used as the adsorbent:
A) Column B) Gas C) Paper D) TLC

C 67. A parenteral is declared to be pyrogenic if the total rise in temperature of the rabbits is:
A) Less than 3.3oC in the 8 rabbits C) More than 3.3oC in the 8 rabbits
o
B) More than 3.4 C in the 8 rabbits D) B and C

D 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

B 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

C 70. Two substances reacting upon reaching the end point must have the same:
A) Normality B) Volume C) No. of equivalents D) Weight

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

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

C 72. The method of assay for sulfonamides is:

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

A 73. Which of the following is a reducing agent?

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

C 74. In using spectrophotometer to measure the concentration of a sample, the following data were obtained:
absorbance of the standard solution = 0.39; absorbance of the sample solution = 0.42; concentration of the standard =
15mcg. The concentration of the sample is:
A) 16.15mcg B) 17.5mcg C) 15.75mcg D) 16.0mcg

A 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

B 77. The method of assay for Vitamin B12 and calcium pantothenate is by:
A) Iodimetry B) Microbial-turbidimetric method C) Fluorometry D) Redox titration

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

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

C 79. Nuclear Magnetic Resonance (NMR) is used for:

A) Radioisotopes B) Irradiation C) Identification of chemicals D) A and B

D 80. In the assay of acetic acid (MW = 60.05), each mL of 1N NaOH is equivalent to:
A) 0.60000g of acetic acid C) 0.60050g of acetic acid
B) 0.00605g of acetic acid D) 0.06005g of acetic acid

C 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

B 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

C 83. The most effective way to clean glass apparatus:

A) Soaking in detergent C) Treatment with a solution of sodium chromate in sulfuric acid
B) Rinsing with nitric acid D) Acetic acid

B 84. Potentiometry finds application in:

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

A 85. If a 0.2250g of sodium bicarbonate (96.5% NaHCO3) is titrated with 0.1165N sulfuric acid. What volume of the acid
is required to reach the end point? At.Wt. of Na = 23; H = 1.0; C = 12; O = 16
A) 22.19mL B) 21.98mL C) 21.20mL D) 21.22mL

A 86. A sample of 0.1350g of arsenic trioxide (As2O3) was assayed iodimetrically using 23.4mL of 0.1055N iodine solution.
The percentage purity of the sample is:
A) 90.44 B) 89.10 C) 90.54 D) 90.23
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C 87. In column chromatography, the separation of the sample mixture into a series of narrow bands in a column is:
A) Chromatogram B) Eluant C) Development D) A and C

B 88. In spectrophotometry procedure for assay, aside from the sample or unknown, this is also required:
A) Raw material of the sample B) Reference C) Dosage form D) A and C

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

A) Formation of a gas C) Formation of soluble products
B) Formation of a precipitate D) Formation of slightly ionized substances

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

A) Absorbance of the sample C) Absorbance of the blank
B) Wavelength to be used D) Concentration of the sample

B 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

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

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

C 93. The unit of wavelength in spectrometry, except:

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

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

A) Use of Mull technique C) Use of alcohol as solvent
B) Use of potassium bromide pellet D) Use of liquid petrolatum as solvent

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

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

C 96. A water content determination method that uses Xylene tube is:
A) Gravimetry B) Karl Fischer titrimetry C) Azeotropic method D) Dew point method

A 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

B 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

D 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

C 100. Substances that have the power of rotating the plane polarized light are said to be:
A) Light sensitive B) Active constituents C) Optically active D) Dextrorotatory

D 101. The indicator used in the assay of a weak acid reacting with a strong base is:
A) Methyl red TS B) Methyl orange TS C) Eriochrome black D) Phenolphthalein TS

D 102. The substance being analyzed is the:

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

D 103. In infrared spectrometry, water is not used as solvent for the sample because the water will:
A) Absorb IR radiation C) Not dissolve the sample
B) Dissolve the sodium chloride cell holder D) A and B

C 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

B 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

D 106. The type of titration in ultimate assay of alkaloids is:

A) Direct B) Residual C) Back D) B and C

A 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
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A 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

C 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 110. The index of refraction of a volatile oil can be determined by:

A) Spectrophotometer B) Pycnometer C) Refractometer D) Polarimeter

A 111. Turbidimetric and nephelometric methods of assay are applied to:

A) Suspensions B) Solutions C) Colored samples D) A and B

C 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

D 113. Way to separate the constituents in gravimetric analysis:

A) Neutralization process B) Physical means C) Chemical means D) B and C

C 114. Way to obtain the gram equivalent of a substance (GEW) is:

A) Based on the replaceable H+ ion C) A or B
B) Based on the valence of the cation D) Based on atomic weight

B 115. Expression of concentration in volumetric solutions, except:

A) Normality B) Titer C) Molarity D) Molality

A 116. The assay procedures in volumetric precipitation were introduced by the following scientists, except:
A) Arrhenius B) Mohr C) Fajan D) Volhard

C 117. The following are characteristics of a product with quality, except:

A) Safe B) Acceptable C) Cheap price D) Effective therapeutically

A 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 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

D 120. The concentration of an unknown sample in spectrophotometric procedures can be calculated by:
A) Use of Beer’s plot C) Use of mathematical formula using a reference standard data
B) Use of chemical factor D) A or C

D 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 C) Use of carbon tetrachloride spray
B) Use of ultraviolet radiation D) A or B

C 122. In paper chromatography, the data needed to compute for Rf value:

A) Distance traveled by the solute C) A and B
B) Distance traveled by the solvent D) Distance traveled by the blank

C 123. The mobile phase in the gas chromatography is consists of:

A) Alcohol-ethyl acetate mixture C) Inert gas
B) Alcohol-chloroform mixture D) A and B

C 124. In gas chromatography, the result in the chromatogram is in terms of:

A) Retention on the column C) A and B
B) Retention of time/volume D) Volume of sample injected in the column

D 125. The components of a blank used in the assay of a substance are, except:
A) Solvent B) Reagent C) Indicator D) Analyte

A 126. The purpose of using a combination of indicators is:

A) To attain a sharp end point C) To attain a complete reaction
B) To facilitate reaction D) A and B

A 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

C 128. The gram equivalent of Magnesium oxide (MW = 40.30) is:

A) 0.0403 B) 0.0215 C) 21.15 D) 0.4030
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C 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

A 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

D 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 132. Flame spectroscopy procedures may be divided into:

A) Flame emission B) Atomic absorption C) Nuclear magnetic resonance D) A and B

D 133. The instrument used to measure sodium and potassium ions quantitatively:
A) Colorimeter B) Refractometer C) Spectrophotometer D) Flame photometer

C 134. The following are optical methods of analysis, except:

A) Colorimetry B) Nephelometry C) Chromatography D) Spectrophotometry

A 135. The calcium and sodium content of the blood can be determined by:
A) Flame spectrometry B) Nephelometry C) Colorimetry D) Turbidimetry

D 136. Thiamine is assayed by:

A) Refractometry B) Potentiometry C) Colorimetry D) Fluorimetry

C 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

A 138. Content uniformity test is conducted in:

A) 10 tablets B) 15 tablets C) 20 tablets D) 30 tablets

D 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 140. The operating speed for paddle in a dissolution apparatus is:

A) 150 rpm B) 100 rpm C) 200 rpm D) 50 rpm

D 141. Beer’s plot in spectrometry is prepared to determine:

A) Absorbance of the sample C) Blank
B) Wavelength to be used D) Concentration of the sample

A 142. The pharmaceutical excipient, which affects the disintegration of a tablet is:
A) Disintegrant B) Lubricant C) Filler D) Colorant

D 143. Antibiotics are assayed by:

A) UV-Vis Spectrometry B) IR C) NMR D) Turbidimetry E) Fluorimetry

D 144. USP limit for tablet content uniformity:

A) 90 – 110% B) 90 – 100% C) 95 – 105% D) 85 – 115%

C 145. The heart of HPLC and GC:

A) Pumps B) Injection valve C) Column D) Detectors E) Integrator

A 146. Gas chromatography is used in the separation of:

A) Volatile liquids B) Amino acid C) Carbohydrates D) Lipids E) Carboxylic acid

D 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

B 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 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

A 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

D 151. The most preferred medium in dissolution testing is:

A) Alcohol B) Acetone C) Ether D) Water E) Benzene
Drug Quality Control Page 8 of 15
C 152. The following are the basic principles behind chromatographic separation, except:
A) Partition B) Adsorption C) Absorption D) Ion-exchange

B 153. The stationary phase used in gas chromatography is:

A) Gas B) Liquid C) Substrate D) Cellulose E) Chromatogram

C 154. The most widely used chromatographic method in drug analysis is:
A) GC B) LLC C) HPLC D) SLC E) TLC

A 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 156. In column chromatography, the resulting patterns with several bands is called:
A) Chromatogram B) Eluate C) Spectrum D) Band E) A and C

C 157. Color of phenolphthalein in vinegar:

A) Pink B) Yellow C) Colorless D) Orange]

D 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 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 160. To find the gram equivalent weight of Phosphoric acid, divide its molecular weight by:
A) 1 B) 0 C) 2 D) 3

B 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

A 162. A chelate must always contain a/an:

A) Multivalent metal B) Ethylenediamine group C) Amine group D) Triple bond

D 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

B 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

A 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 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 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

C 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

B 169. The titrant most commonly used for direct compleximetry titration is:
A) Zinc sulfate B) EDTA C) AgNO3 D) HclO4

A 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 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

B 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

D 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
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D 174. Assay of Sodium Nitrite is an example of:
A) Neutralization B) Precipitation C) Complexation D) Redox method

C 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

B 176. Ceric sulfate is a/an:

A) Precipitating agent B) Oxidizing agent C) Reducing agent D) Complexing agent

D 177. The valence number of Mn in KMNO4 is:

A) +2 B) +1 C) +5 D) +7

D 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

B 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%

C 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 181. The following are methods of determining the end point in precipitimetry, except:
A) Use of adsorption indicators C) Formation of turbidity
B) Cessation of precipitation D) Appearance of turbidity

B 182. The reagent that loses the electron/s in a redox reaction is the:
A) Substance that decreases in oxidation number C) Reducing agent
B) Oxidizing agent D) Substance reduced

D 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

C 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

A 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 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 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 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

B 189. Hexane is the best solvent for extracting:

A) Resins B) Fats C) Volatile oils D) Acids

D 190. Alkaloidal test solutions include:

A) Valser’s TS B) Warner’s TS C) Mayer’s TS D) Any of the above

A 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

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
A 192. Moisture content in grams:
A) 1.146 B) 1.144 C) 1.164 D) 1.166
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B 193. Percent moisture:
A) 12.64% B) 12.46% C) 12.45% D) 12.54%

C 194. Total ash content in grams:

A) 0.545 B) 0.555 C) 0.554 D) 0.445

B 195. Percent total ash:

A) 6.20% B) 6.02% C) 6.22% D) 6.92%

A 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

B 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

A 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

B 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

A 200. The soluble constituents of crude drug in a certain solvent:

A) Extractive B) Ash C) Crude fiber D) Phytosterol

D 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 202. A reaction is led to completion by:

A) Formation of ash C) Production of slightly ionized molecules
B) Formation of insoluble acid D) All of the above

D 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

C 204. The primary standard used to standardize Karl Fischer reagent is:
A) Anhydrous sodium carbonate C) Sodium tartrate
B) Potassium bipthalate D) Sodium oxalate

B 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

C 206. Oils with iodine value above 120 are classified as:
A) Non-drying B) Semi-drying C) Drying D) None of the above

B 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 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 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

D 210. Quantitative determinations of alkaloids may be done by:

A) Volumetric B) Gravimetric C) Spectrophotometric D) Any of the above
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D 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%

A 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 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

B 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

A 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

C 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

A 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

D 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

B 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

C 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

A 221. Efficiency of HEPA filters is assessed using:

A) DOP test B) Water attack test C) Carr’s index D) Bubble point test

A 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 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

B 224. Water attack test is used in this type of glass container:

A) Type I B) Type II C) Type III D) Type III

A 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 226. The process by which the exact concentration of a solution is determined is:
A) Standardization B) Neutralization C) Redox S) Acidimetry

B 227. The apparatus used to keep samples free from moisture is:
A) Oven B) Dessicator C) Furnace D) A and C

D 228. Materials being controlled by Quality Control, except:

A) Active ingredient B) Excipients C) Finished products D) Packages

A 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
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B 230. Neutralization reactions in titrimetric methods of analysis may be:
A) Precipitimetry B) Alkalimetry C) Compleximetry D) A and C

C 231. The type of ligand where EDTA belongs;

A) Unidentate B) Bidentate C) Hexadentate D) Tridentate

C 232. To remove stains of iodine, the most effective chemical substance is:
A) Calamansi juice B) Hydrogen peroxide C) Sodium thiosulfate D) Sodium hypochlorite

B 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

D 234. Light scattering method of analysis include/s:

A) Flourometry B) Turbidimetry C) Nephelometry D) B and C

C 235. Ferric alum TS is used as indicator in volumetric precipitation method if the titrant is:
A) AgNO3 B) BaCl2 C) NH4SCN D) NH4Cl

B 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

C 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

A 239. A spectrophotometer differs from a colorimeter because it consists of:

A) Prism B) Lamp house C) Cell compartment D) Optical scale

A 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

D 241. Volatile oils are complex compounds composed of:

A) Phenols B) Inorganic salts C) Hydrocarbons D) A and C

D 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

B 243. The acid necessary for permanganate titrations is:

A) Acetic acid B) Sulfuric acid C) Hydrochloric acid D) Nitric acid

A 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 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

D 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 C) Not less than two labeled containers
B) Three labeled containers D) Any of A and C

D 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 248. Sources of quality variations are as follows, except:

A) Technician B) Inadequate procedure C) Equipment D) General manager

C 249. Acetylation method of analysis in volatile oils is done to determine:

A) Phenol B) Aldehyde C) Alcohol D) Ketone

D 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

A 251. The material used to make the cell holder for infrared analysis are, except:
A) Sodium bromide B) Potassium bromide C) Sodium chloride D) Potassium chloride

B 252. Calculate the water content of streptomycin powder weighing 4.20g as sample. The water equivalence factor (F) of the
Karl Fischer reagent was found to be 5.1 and the volume consumed was 11.50. The % of water is:
A) 1.39 B) 1.40 C) 1.41 D) 13.96

B 253. The Karl Fischer reagent used for moisture content determination consists of the following except:
A) Pyridine B) Acetone C) Sulfur dioxide D) Iodine
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A 254. This is the sum of all tests performed to determine the conformance of the product to specifications:
A) Quality control B) Quality Assurance C) CGMP D) A and B

A 255. Complex inorganic compounds that are used to determine the end point in titration:
A) Indicators B) Standard solutions C) Precipitating agents D) None of the above

B 256. The name of the originator who introduced the use of 0.1N silver nitrate as the titrant and potassium chromate TS as
the indicator in volumetric precipitation of chlorides is:
A) Volhard B) Mohr C) Fajan D) Beer

A 257. In the assay of ascorbic acid by iodimetry, it acts as:

A) Reducing agent B) Oxidizing agent C) Buffer D) Neutral agent

C 258. This is the weight of the substance chemically equivalent to 1 mL of the standard solution:
A) Titrand B) Equivalence point C) Titer D) End point

A 259. When a strong acid is titrated against a weak base, the indicator is:
A) Methyl red B) Phenolphthalein C) Methyl orange D) Crystal violet

C 260. Residual titration method under EDTA titrations is applied to metal ion:
A) Zinc B) Calcium C) Bismuth D) A and C

B 261. The gram equivalent weight of potassium permanganate (MW = 158.03) is:
A) 29.60 B) 31.60 C) 158.03 D) 79.01

D 262. Assay method that determines the presence of pyrogens in injectables:

A) Rabbit test B) Limulus amoebocyte lysate test C) White mice test D) A and B

A 263. The measurement of a weak base in nonaqueous medium of a given sample by titration with standard perchloric acid:
A) Acidimetry B) Alkalimetry C) Compleximetry D) Redoc titration

C 264. This is used for quantitative preparation of a standard solution:

A) Pipet B) Graduated cylinder C) Volumetric flask D) Buret

B 265. Which of the following is an oxidizing agent?

A) Ascorbic acid B) KMNO4 C) Sodium thiosulfate D) Sodium nitrite

A 266. The concentration of official diluted alcohol is:

A) 10% B) 50% C) 80% D) 70%

A 267. The oxidation number of atomic iodine is:

A) +1 B) +2 C) +4 D) +3

A 268. Safety and toxicity tests are conducted for:

A) Plastic tubings B) Solutions in vial C) Tablets D0 Oral liquids

B 269. The type of ash where sulfuric acid is used to whiten the ash is:
A) Acid-insoluble ash B) Sulfated ash C) Loss on ignition D) Residue on ignition

A 270. A sample of 0.1350 g of As2O3 was assayed iodimetrically using 23.4 mL of 0.1055N Iodine solution. The percentage
purity of the sample is: At.wt. of As = 74.92; O = 16
A) 90.44 B) 90.23 C) 89.00 D) 90.54

A 271. The residue after incineration of a drug was 0.1185 g from a sample of 7.0 g. The percentage of ash is:
A) 1.56 B) 2.56 C) 2.0 D) 1.55

C 272. Calculate the amount of caffeine extracted from coffee beans using 1.0215g of the sample. The volume of 0.0252N
H2SO4 added to the extract was 25.4 mL, the excess titrated by 21.75 mL of 0.02115N NaOH. Each mL of 0.02 N
H2SO4 is equivalent to 3.8858 mg of caffeine (C9H10O2). The percentage of caffeine is:
A) 3.40 B) 3.50 C) 3.42 D) 3.60

A 273. If a 0.4600g of potassium iodide (KI) yielded a 0.715g of silver iodide precipitate by gravimetric assay, what would be
the percentage purity of KI? At.wt.: Ag = 107.87; K = 39.1; I = 126/9
A) 110.90 B) 110.89 C) 45.08 D) 109.90

B 274. Compute for the Rf value of a substance if the substance traveled by the solvent is 12.5 cm and the distance traveled
by the sample is 7.5 cm:
A) 0.70 B) 0.60 C) 1.67 D) 1.66

C 275. Compute for the percentage loss on ignition of magnesium sulfate hydrated using 3.20 g sample yielding a residue of
2.15g. The loss is:
A) 33.81% B) 32.98% C) 32.81 D) 32.75%
Drug Quality Control Page 14 of 15
A 276. If a 0.3800 g sample of sodium sulfate yielded 0.55 g of barium sulfate precipitate by gravimetric assay, what would
be the percentage purity of sodium sulfate? At.wt.: Ba = 173.3; S = 32.06; Na = 23; O = 16
A) 88.11 B) 99.94 C) 99.15 D) 88.51

D 277. Analysis of substances that fluoresce falls under:

A) Fluorometry B) Requires UV light C) Absorbance reading is obtained D) A and B

A 278. An instrument in spectrometry using the filter as radiant energy device:

A) Filter photometer B) Infrared spectrometer C) UV – Vis spectrometer D) Flame photometer

D 279. Region in an electromagnetic spectrum:

A) Visible B) Infrared C) Ultraviolet D) All of the above

A 280. Cause of quality variation due to men:

A) Fatigue due to overwork B) Requires high salary C) Resourceful at work D) B and C

A 281. Acetylene and aldehyde group present in a compound that absorbs radiant energy are called:
A) Chromophore B) Inactive C) Inert D) B and C

B 282. The reading that must be obtained in a spectrophotometer:

A) Concentration error B) Absorbance C) Retention D) Angular rotation

C 283. The acid used in sulfated ash determination of a crude drug is:
A) Diluted HCl B) Nitric acid C) Sulfuric acid D) Any of the above

A 284. Silica from the soil that is left after treatment of the ash with diluted HCl is the:
A) Acid-insoluble ash B) Sulfated ash C) Residue on ignition D) Loss on ignition

B 285. The end point in the water content determination using Karl Fischer reagent is determined by:
A) Use of chemical indicator C) Use of spectrometer
B) Use of potentiometer or volumeter D) A or B

A 286. In microbial assay, the instrumental method used to prepare the inoculum is:
A) Turbidimetry B) Nephelometry C) Chromatography D) A and B

D 287. A polarimeter is used whether a substance is:

A) Dextrorotatory B) Levorotatory C) Optically active D) All of the above

A 288. A similar preparation in spectrometry refers to:

A) Reference standard and sample identically made C) Sample greater than reference standard
B) Reference standard greater than sample D) All of the above

A 289. Stoichiometric point in titration means that:

A) Equivalent amounts of the titrant and analyte have reacted.
B) Normality or molarity of the reactants are the same.
C) End point in titration has been reached
D) A and C

D 290. In-process control tablets include the following, except:

A) Weight B) Hardness and thickness C) Disintegration D0 Bioavailability

A 291. Content uniformity test is to be performed for all products whose active ingredient is:
A) 50 mg or less B) 130 – 134 mg C) 130 mg or less D) 324 mg or more

C 292. A date limiting the time during which a preparation may be expected to have retained its labeled potency:
A) Shelf life B) Audit time C) Expiry date D) Any of the above

A 293. To identify the place where materials have to be stored in a material warehouse, a _____ is pasted on the container
of the material.
A) Sticker B) Label C) Ribbon D) None of the above

C 294. Caps, bottles, labels and shipping containers are considered as:
A) Active components B) Drug products C) Packaging materials D) None of the above

A 295. A ____ is a specific amount produced according to a single manufacturing order during a single period of production.
A) Batch B) Lot C) Component D) None of the above

B 296. One batch can be broken into several:

A) Ingredients B) Lots C) Components D) None of the above

A 297. The recommended maximum limit for overage of vitamins is:

A) 30% B) 10% C) 90% D) None of the above
Drug Quality Control Page 15 of 15
B 298. ______ is the comparing of attributes and dimensions of a product against a standard to find out if the product is
within the prescribed limit.
A) Sampling B) Inspection C) Analysis D) Action

A 299. A ______ is a definite working rule regarding N, n and c.

A) Sampling plan B) QC analysis C) Risk D) Chart

C 300. Accelerated stability testing is, except:

A) Performed at higher temperatures to intensify degradation through time
B) Done to determine the shelf life of the product in a short period of time
C) Enough proof of shelf life and need not be further validated
D) The initial method used to determine a product’s shelf life