Documente Academic
Documente Profesional
Documente Cultură
A 1. Most of the official drugs containing calcium and zinc are assayed by:
A) EDTA method B) Gravimetry C) Nonaqueous titrimetry D) Acidimetry
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 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
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
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
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
MANOR Review Center 173
Drug Quality Control
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
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 35. In phenol content determination of a volatile oil, the layer in the graduated neck of the Cassia flask reached 2.7mL
obtained from a sample of 10mL after treatment with KOH solution. The percentage of oil is:
A) 73% B) 69% C) 7.3% D) 27%
A 41. In the microbial assay of antibiotics, the microorganism used for Penicillin G is:
A) Staphylococcus aureus C) Escherichia coli
B) Pseudomonas aeruginosa D) Bacillus subtilis
A 43. The period of stability of a preparation is the time from the date of manufacture of the formulation until its chemical or
biological activity is not less than ___ of labeled potency:
A) 90% B) 95% C) 93% D) 99%
A 45. Drug substances that are withheld from distribution until batch certification from BFAD has been received:
A) Antibiotics B) Antineoplastics C) Vitamins D) All of the above
A 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
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
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
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
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
B) More than 3.4oC 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 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
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
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
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
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
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
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 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
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
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 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
A 116. The assay procedures in volumetric precipitation were introduced by the following scientists, except:
A) Arrhenius B) Mohr C) Fajan D) Volhard
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
B 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
MANOR Review Center 177
Drug Quality Control
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
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 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 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
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 133. The instrument used to measure sodium and potassium ions quantitatively:
A) Colorimeter B) Refractometer C) Spectrophotometer D) Flame photometer
A 135. The calcium and sodium content of the blood can be determined by:
A) Flame spectrometry B) Nephelometry C) Colorimetry D) Turbidimetry
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
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
A 142. The pharmaceutical excipient, which affects the disintegration of a tablet is:
A) Disintegrant B) Lubricant C) Filler D) Colorant
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
C 152. The following are the basic principles behind chromatographic separation, except:
A) Partition B) Adsorption C) Absorption D) Ion-exchange
C 154. The most widely used chromatographic method in drug analysis is:
A) GC B) LLC C) HPLC D) SLC E) TLC
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
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
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
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 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
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
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
C 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 191. How many mL of water is expected from a 20 g Digitalis sample containing 1.5% moisture?
A) 0.3 mL B) 30 mL C) 3 mL D) None of the above
A 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
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 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
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
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
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
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
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 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
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
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
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 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 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
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 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
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
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
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
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
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) 76.33 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%
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
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
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
MANOR Review Center 184
Drug Quality Control
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
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 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
x=30g
1.5ml NaOH x
x = 45mL
22. A
Permanganate ion is a strong oxidizing agent while oxalate ion is a reducing agent, that’s why it can remove the
stain of Potassium permanganate ( 2, p. 158 – 159 )
23. C
Ester value - number of mg of KOH required to saponify 1g of oil (2,p. 257 )
24. C
= 0.1 x 30mL x 34
2 x 1000 x 100
-------------------------------
2g
%P = 2.55%
26. B
Direct titration with EDTA – Calcium, Magnesium, Zinc (2,p. 149 )
Residual titration – Bismuth and Aluminum compounds ( 2, p. 152 )
27. C
Oxidation- Reduction - analysis involve a change in valence of reacting substance ( 2, p. 158 )
Neutralization – chemical process in which an acid reacts with a base ( 2,p. 64 )
Precipitation – a class of reactions is dealt with that requiring the formation of relatively insoluble substance
(2,p. 130)
Complexation – refer to no.1
28. C
Iodometry – analysis of oxidizing agents, such as ferric and cupric salts reduced with excess KI and iodine is produced
Iodimetry- analysis of reducing agents such as thiosulfate and arsenites by the use of solutions of iodine ( 2,p. 174 )
29. B
30. A
Malic acid – Indirect Permanganate oxidation method
The indirect method of permanganate oxidation is employed of those compounds that can be connected through
chemical reactions through an equivalent amount of oxalate, which in turn can then be quantitatively oxidized by
permanganate. In the assay for the malic acid, amount of cherry juice, the malic acid is converted to an equivalent
amount of a salt, which is converted to insoluble Calcium oxalate, the oxalate is then liberated and then oxidized with
permanganate. ( 2, p.162-163)
31. A
Iodometry – analysis of oxidizing agents, such as ferric and cupric salts reduced with excess KI and iodine is produced
(2, p. 174)
32. A
33. A
Assay for aldehyde – Bisulfite method (2,p.263 )
Aldehydes form oxidation products with certain reagents. The bisulfite addition products dissolves in water, leaving the
nonaldehyde constituent as a water-insoluble layer. The volume of the water-insoluble layer is then measured ina cassia
flask.
34. A
35. A
% Phenol content = V (sample) – V (residual) x 100
V (sample)
= 10 – 2.7 x 100
10
= 73%
36. D
An important function of the preformulation group is the prediction of the physical and chemical stability of a new drug. It
permits the calculation of the rate of decomposition of a substance at a given time, thus, their shelf life can be determined
(3, p.35)
37. B
Dissolution tester – determines the dissolution of a drug. The speed, or rate at which a drug substance dissolves in a
medium is called the dissolution rate. (1, p. 38)
38. A
AAS – trace analysis of metals
UV/VIS – quantitative analysis
39. B
40. A
41. A
Microbial tests – Penicllin- S.aureus ( 3, p.728 )
42. C
Expiration date – the date identifies the time during which the prouct may be expected to maintain its potency and remain
stable unde rdesigned storage condition.(1., p.86)
43. A
44. D
Primary packaging component/immediate container – that which is in direct contact with the article at all time ( 1,p. 155 )
45. A
46. D
47. D
48. A
49. D
50. C
51. C
52. C
53. C
54. D
15 mcg = x
0.39 0.42
x = 16.15mcg
76. A
77. B
78. B
The glass electrode is the most popular of all indicator electrode for pH determination. Because of he high resistance of
glass, pH measurements must be made using an electronic measuring device called oH meter. (2,p.380)
79. C
80. B wt. (g) x (g)
------------ -------
N= MW/ f N= 60.05/1
------------------- ----------------- X = 0.00605g of acetic acid
0.001L 0.001L
81. C
82. B
One of the fundamental laws in spectrophotometry is Beer’s law. It states that the power of transmitted radiant beam
decreases exponentially as the conc of the soln. containg the absorbing chem.. species increases arithmetically.
(2,p. 301)
83. C
84. B
Potentiometry – determination of hydrogen-ion concentration or pH of a solution (2,p. 377)
MANOR Review Center 188
Drug Quality Control
85. A
86. B
87. C
Eluant – solvents used to wash the column in elution chromatography ( 2,p.340)
88. B
89. C
90. D
One of the fundamental laws in spectrophotometry is Beer’s law. It states that the power of transmitted radiant beam
decreases exponentially as the conc of the soln. containg the absorbing chem.. species increases arithmetically.
(2,p. 301)
91. B
refer to no.90
92. A
Polarimetry- study of optical activity of substances (2,p. 421)
93. C
The units of wavelength measurement generally used in spectrometry are the um( micrometer), which is equal to 10-, 4
cm., nanometer ( nm ), which is equal to 10-7cm, and less frequently the Angstorm (A), which is equal to 10-8 cm. ( 2,p.
295)
94. C
95. D
The term chromatography is derived form the method’s original use in the separation of colored compounds on a suitable
adsorbent. The technique, however, is applicable to the separation of colored compounds as well. (2, p.338)
96. C
The xylene method, developed by the US Forestry Services, has been modified and is one of the official methods for
moisture determination. It is referred toa s the azeptropic method in the USP and the moisture method by toluene distillation
in the NF (2, p. 227)
97. A
C1V1 = C2V2
( x) ( 22.5mL) = ( 1.1055N)(20.70mL)
x=1.0171
98. B
Direct titration
%P = N x V x MW
f x 1000 x 100
---------------------------
wt. (g)
= 0.23N x 16.67mL x 100.08
2 x 1000 x 100
----------------------------------------
0.2545 g
= 75%
99. D
100. C
Many organic substances, such as certain constituents of volatile oils, alkaloids, and sugars, possess the power of rotating
plane polarized light where the latter is passed through solutions containing them. Substances that possess this power is
said to be optically active and are designated dextrorotatory when the direction of the rotation is toward the right, and
levorotatory when it is toward the left. ( 2,p. 419)
101. D
Weak Acid + Strong Base Phenolphtalein (pH 8-10) * colorless to red
Weak Base + Strong Acid Methyl Red ( pH 4.2-6.2) * red to yellow ( 2, p.68)
102. D
Analyte – substance being analyzed
Titrant – solution of known concentration ( 2, p.56 )
103. D
104. C
Lambert’s or Bouguer’s Law – states that the power transmitted radiant beam decreases exponentially as the thickness of
the solution containing the absorbing chemical species increases arithmetically. ( 2, p. 301)
105. B
Interaction of iodine and iodide ion with the colloidal β-amylose result in the production of an intensely-blue colored
compound, and the color change reversible, the color bing discharged when the iodine is reduced with sodium thiosulfate or
another reducing agent. ( 2, p. 176)
106. D
107. A
108. A
%P = ( N1V1-N2V2) x MW
f x 1000 x 100%
wt.(g)
= [(1.0340)(50)-(1.1255)(24.6)] X 40.3
_________________________2 X 1000 x 100%
12.35g
= 3.92%
109. C
The total alcohols present in any given oil are determined by transferring the free alcohols into the corresponding acetates
by binding the oil with acetic anhydride in an acetylization flask and then determine the saponification value of the
acetylized product
110. C
Refractometer – measures the index of refraction ( 2, p.427)
MANOR Review Center 189
Drug Quality Control
111. A
Turbidimetric & Nepholometric methods are applied to suspensions (2, p. 325)
112. C
The material placed in the column to adsorb the drug is referred to as the adsorbent. Purified siliceous earth, activated
alumina, silica gel, and column carbonate are examples if adsorbents commonly used. ( 2, p. 339)
113. D
114. C
GEW, or more simply, the gram-equivalent of a chemical is defined as that wt in g. which is chemically equivalent to 1g-
atom of hydrogen. In neutralization reactions, it is defined as that wt. of a substance in grams which contains, furnishes,
reacts with directly or indirectly, or replace 1g-atom or ion of hydrogen. (2. P.57)
115. B
Normality – number of equivalents of solute/liter or milliequivalent/mL of solution. ( 2, p. 57)
Molarity – moles/liter of solution
Molality – moles/kg of solvent
Titer – wt. of a substance chemically equivalent ot 1mL of a std. solution
116. A
117. C
118. A
The theoretical point at which equivalent amount of each have reacted is the stoichiometric point or the equivalence point.
( 2, p. 56)
119. B
The official methods often direct that a drug be dried to constant weight. The term dried to constant weight means that 2
consecutive weighings do not differ by more than 0.5mg/g of substance taken for the determination, the second weighing
following an additional hr. of drying. ( 2, p.16)
120. D
A plot of absorbance values against a series of known solute called a Beer’s plot, should yield a straight line. From
t his plot the unknown solute concentration is determined merely by measuring the absorbance value of the solution and
finding the concentration value which corresponds to the measured absorbance value. ( 2, p. 307)
121. D
122. C
Rf = distance of solute/distance of solvent ( 2, p. 347)
123. C
For colorless compounds, detection of spot can be made by treating with reagents like conc. sulfuric acid ( the organic
components char after the chromatogram have been sprayed with sulfuric acid and treated ) or iodine vapor ( the organic
components react with iodine vapor and form brown spots ) or examined under UV radiation to make the spots discernible. (
2. P. 351)
124. C
In Gas Chromatography, the position of the peak on the chromatogram is characteristic of the component and is measured
in terms of its retention on the column. The terms most frequently used to describe retention are retention time and
retention volume. ( 2, p. 354-355)
Retention time – time required by an average molecule of component to pass from the injection point through the column to
the detector.
Retention volume – vol. of carrier gas necessary to carry an average molecule of the component from the point of injection
to the detector.
125. D
126. A
127.
128.C
129. C
%P = N x V x MW
f x 1000 x 100
---------------------------
wt. (g)
130. A
Nephelometry - based on the measurement of the brightness of the light reflected by a cloud of finely divided particles
suspended in a liquid ( 2, p. 324)
131. D
132. D
The flame spectroscopic methods most frequently used for anasis are flame emission spectrophotometry and atomic
absorption spectrophotometry. ( 2. P. 320)
133. D
134. C
Colorimetry – branch of spectrophotometry iin which the absoption measurement is made in the visible region of the
spectrum. ( 2, p. 296)
Nephelometry - based on the measurement of the brightness of the light reflected by a cloud of finely divided particles
suspended in a liquid ( 2, p. 324)
Spectrophotometry – branch of spectrometry which embrases the measurement of the absorption by chemical species, of
radiant energy of definite and narrow wavelength, approximating monochromatic radiation. ( 2,2p.295)
Chromatography – A process in which a solution of a mixture containg inert materials, drug principles, and impurities is
separated into its components while moving through a bed of fixed porous solid having different affinities for substance
being separated. ( 2,p.338)
135. A
Flame spectroscopy – used in the assay if lithium carbonate, USP XIX. This technique is also used for assay of other
elements such as K,Na, and Ca in blood and other biological samples. ( 2, p. 320)
136. D
Fluorometry has found the most application in the analysis of vitamins, in particular, the analysis of thiamine and riboflavin. (
2, p. 324)
137. C
Chromophore – functional group which absorbs radiant energy in the UV or VIS region of the spectrum ( 2,p. 296)
examples are: ethylene, ketones, acetylene, organic acids, aldehydes, azomethines
138. A
MANOR Review Center 190
Drug Quality Control
139. D
Wavelength – the length of a complete wave or cycle, from the peak of one wave to the peak of the next ( 2,p. 295)
Frequency – number of complete cycles which pass a given pt. per second ( 2,p.296)
Electromagnetic spectrum – used to define the complete system of energy propagated in wave form. Energy of the
nature is referred to as radiant energy and appear in such apparently different forms as sunlight,
color, radio waves, etc. ( 2,p. 295)
140. D
141. D
142. A
143. D
Turbidimetric methods are used in official assay of the majority of antibiotics, calcium pantothenate, Vit, B12, & other
medicial agents. In these methods, the activity of the biological agent is determined by measuring the turbidity produced in
a series of antibiotics. The greater the turbidity ( due to microbial growth), the less the activity of the antibiotic. ( 2,p.325)
144. D
145. C
146. A
147. D
148. B
149. B
150. A
151. D
152. C
The basic principles upon which chromatographic separation depends on adsorption, partition, ion-exchange and molecular
exclusion.
153. B
Gas Chromatography, uses as the mobile phase, an inert gas called the carrier gas. The stationary phase, also referred to
as the liquid substrate, usually consists of a high-boiling liquid, which is used to contain granular particles made of siliceous
earth. ( 2,p.354)
154. C
155. A
156. A
157. C
Since vinegar is acidic, then the color of phenolphthalein is colorless.
158. D
Sodium oxalate is the best standard to use in the standardization of Potassium Permanganate, since it can be obtained in
very pure condition. (2,p.161)
159. D
Indicators are complex organic compounds used to determine the endpoints in neutralization process, to determine
hydrogen-ion concentration or pH, to indicate that a desired change in pH have been affected. These organic compounds
may be acids or bases themselves, capable of existing in 2 forms of different color that are mutually invertible into the other
at given hydrogen-ion concentration. ( 2,p. 66)
160. D
H3PO4 - factor is 3, because the valence cation is 3
161. B
If the combining molecule contains 2 or more groups that donate electron, this complex is called a chelate. ( 2,p. 145)
complex- term used when a metal ion combines with a molecule which can donate electron ( 2,p.145)
Masking agents- compound capable of entering a complexation reaction, it is used to indicate the determination of metal in
the presence of another metal.
162. A
EDTA will react with metal to form a water-soluble, stable complex, or chelate compound. The reaction is rapid and
quantitative with such polyvalent metal ions as Al+3 , Bi+3, Ca+2, Hg+2, Mg+2, Zn+2 ( 2, p.145 )
163. D
164. B
wt. (g) 0.05g __
------------ 106/2
N= MW/ f = ------------------ = 0.94N
------------------ 0.001L
0.001L
165. A
Direct titration
%P = N x V x MW
f x 1000 x 100
---------------------------
wt. (g)
= 0.1 x 30mL x 34
2 x 1000 x 100
-------------------------------
2g
%P = 2.55
166. A
Since the computed percentage of peroxide is 2.55%, and the official requirement id=s 2.5g-3.5g of hydrogen peroxide/100
parts, then the sample conformed with the standard requirement.
167. A
1 divided by 20 is 0.05. So 1/20M is 0.05M
168. C
169. B
171. A
172. B
173.
174. D
175. C
176. B
177. D
KMnO4
K+1 Mn x O4 -2
1 + x + (-2)(4) =0
x = +7
178. D
179. B
180. C
25%= 25g/100mL
C1V1=C2V2
( 25)(100)=(x)(500)
181. C
The endpoint of a reaction in analysis by precipitation methods may be determined by:
a.) Cessation of precipitation or the appearance of turbiduty
b.) use of internal indicators
c.) Instrumental methods , ex. Potentiometric or amperometric
182. C
Reducing agent – reactant which loses electrons in oxidation-reduction reaction (2,p.157)
Oxidizing agent - reactant which gains electrons in oxidation-reduction reaction
183. D
Primary standard – weighed sample of a substance of known purity ( 2,p. 58 )
184. C
The metal ion which are determined by direct titration with EDTA are Ca, Mg, Zn. (2, p.149 )
185. A
Titration- act of adding and measuring the volume of titrant used in assay ( 2,p. 56)
186. A
187. A
188. A
189. B
Solvent hexane is a good solvent for fats and fatty oils (2, p.234)
190. D
Alkaloidal tests include:
a.) Valser’s reagent - mercuric iodide TS
b.) Wagner’s reagent – Iodine in KITS
c.) Mayer’s reagent – Mercuric Potassium Iodide
d.) Dragendorff’s – K Bi iodide
e.) Sonnenschein – phosphomolybdic acid
f.) Scheibler’s- phosphotungstic acid
191. A
mL of moisture/water = wt. of sample x moisture content
= 20g x 1.5%
= 0.3mL
192. A
wt. of moisture = ( wt. of crucible + sample) – ( wt. of crucible + sample after drying to constant wt.)
= 1.146g
193. B
% moisture= wt of moisture/ wt. of sample x 100%
= 1.146/ x 100%
= 12.46%
194. C
Weight of residue = 53.006g-52.452g= 0.554g
195. B
% total ash = wt. of residue/wt. of sample
= 53.006g – 52.452g/ 61.648g – 52.452g
= 6.02%
196. A
ACID VALUE (mg/g) = V x N x 56.11/ wt.(g) = 30 x 0.110 x 56.11 / 1.230g = 150.54 mg/g
197. B
Loss on Drying = wt. initial – wt.final
= ( wt. of tare + sample before drying)-( wt. after drying )
= 0.125g
198. A
% H20 = mL of KFR x EF/ wt. of sample(mg) x 100%
= 9.2 x 4.6 / 350mg x 100%
= 12.09%
= [(0.225N)(20mL)-(0.0295N)(12.5mL)] x 5.788
1 x 1000 x 100%
10.7g
= 0.22%
212. A
Iodine value = ( Vb-Vr) x N x 0.1269
wt.(g)
= ( 25.7-10) x 0.1065 x 0.1269
0.2048g
= 103.61%
213. A
214. B
215. A
216. C
217. A
218. D
acid-insoluble ash – part of the total ash which is insoluble in diluted HCl (2,p.223)
219. B
220. C
37+/- 2C
221. A
222. A
223. A
224. B
225. A
226. A
Standardization – determination of the normality or molarity of a solution ( 2,p. 58)
227. B
Dessicator – special form of glass vessel, rendered airtight by means of ground contact surfaces, used to maintain a dry
atmosphere for objects that might be affected by moisture or carbon dioxide. ( 2,p.16)
228. D
229. A
230. B
Neutralization reactions are chemical process in which an cid reacts with a base (2,p.64)
231. C
The four oxygen and the 2 N atoms of the EDTA molecule capable of entering a complexation reaction with a metal ion
would make it a hexadentate molecule. The EDTA moleculae which provides groups for attachment to metal ion is called a
ligand. (2,p.146)
232. C
264. C
Volumetric flasks are used to make up standard solution to a given volume. (2,p.61)
265. B
266. B
267. A
268. A
269. B
270. A
Direct titration
%P = N x V x MW
f x 1000 x 100
---------------------------
wt. (g)
271. A
% ash = wt. of residue /wt. of sample x 100%
= 0.1185g/7.0g x 100%
= 1.6%
273. A
%P = wt. of residue x MW sample x 100%
wt. of sample MW residue
276. A
%P = wt. of residue x MW sample x 100%
wt. of sample MW residue
= 76.33%
277. D
278. A
279. D
280. A
281. A
Chromophore – functional group which absorbs radiant energy in the UV or VIS region of the spectrum ( 2,p. 296)
examples are: ethylene, ketones, acetylene, organic acids, aldehydes, azomethines
282. B
Spectrophotometry – branch of spectrometry which embrases the measurement of the absorption by chemical species, of
radiant energy of definite and narrow wavelength, approximating monochromatic radiation. (2, p.295)
283. C
284. A
acid-insoluble ash – part of the total ash which is insoluble in diluted HCl (2,p.223)
285. B
286. A
Turbidimetric methods are used in official assay of the majority of antibiotics, calcium pantothenate, Vit, B12, & other
medicial agents. In these methods, the activity of the biological agent is determined by measuring the turbidity produced in
a series of antibiotics. The greater the turbidity ( due to microbial growth), the less the activity of the antibiotic. ( 2,p.325)
287. D
Polarimeter- measure the optical acitivty of liquid substances. If the analyzer is turned to the right, then it is dextrorotatory ,
when the analyzer must be turned to the left, then it is said to be evorotatory. (2,p.420)
288. A
289. A
The theoretical point at which equivalent amount of each have reacted is the stoichiometric point or the equivalence point.
( 2, p. 56)
290. D
291. A
292. C
Expiration date – the date identifies the time during which the prouct may be expected to maintain its potency and remain
stable under designed storage condition. (1, p.86)
293. A
294. C
295. A
296. B
297. A
298. B
299. A
300. C
References:
1
Ansel, Howard et al. Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lippincott Williams and
Wilkins. 1999
2
Knevel, Adelbert M. Jenkins’ Quanititative Pharmaceutical Chemistry.7th ed. USA: Mc-Graw Hill, Inc. 1977
3
Lachman, Leon. PhD et al. The Theory and Practice of Industrial Pharmacy. 2nd ed. Philadalphia: Lea & Febiger. 1979