Font size
WorksheetsQuality Assurance and Quality Control Part I
Total questions: 100
Worksheet time: 4hrs 30mins
A buret with a glass stopcock can be used for:
Alcohols
Acids
Bases
Bleeding is a main stability problem seen in
Capsules
Emulsions
Ointments
Tablets
To keep samples moisture-free the apparatus used is:
Desiccator
Furnace
Incubator
Oven
In neutralization methods in aqueous medium, a product is:
Oil
Salt
Precipitate
The instrument used to measure the optical activity of the sample is:
Refractometer
Polarimeter
Spectrometer
Flame photometer
Assay of zinc oxide is what type of analysis?
Alkalimetric residual
Acidimetric direct
Acidimetric residual
Alkalimetric direct
Titer is an expression of concentration of solution is determined.
g of solute/ 100 mL
g or mg/mL
g of solute / L
Which of the following chemicals is not included in preparing the Karl Fischer reagent?
Pyridine
Acetone
Sulfur dioxide
Iodine
To remove stain of KMnO4, the most effective chemical substance is :
Oxalic acid
Sodium thiosulfate
Vinegar
Bromine solution
The primary standard used in the standardization of the above VS is:
Sodium carbonate
Sodium bicarbonate
Potassium biphthalate
Benzoic acid
To determine the total ash, the sample is incinerated at a temperature of 675 + - 25°C. This temperature is represented by:
Very dull heat
Dull red heat
White red heat
Bright red heat
Method II of determining iodine value is also known as:
Hub’s method
Wij’s method
Hanus method
All of the choices
Dichlorophenol-indophenol solution is standardized using:
Sulfanilamide USP
Ascorbic acid USP
Sulfathiazole USP
Resorcinol USP
Koppeschaar’s solution is also known as:
0.1 N Iodine solution
0.1 N Bromine solution
0.1 M sodium nitrite solution
0.1 N sodium thiosulfate solution
The following is/ are true about EDTA titration.
I. EDTA titration is also known as complexometric titration.
II. The equilibrium constant in EDTA titration is called EDTA indicator.
III. For end-point detection, commonly used indicator is called EDTA indicator
IV. EDTA titration technique includes displacement titration.
I only
II and III
I, II, and III
I, II and IV
I, II, III and IV
The following is/are true about auxillary complexing agent.
I. Eriochrome black is an example of an auxillary complexing agent
II. Auxillary complexing agents are also ligands
III. Auxillary complexIng agents binds the metal strong enough to prevent the hydroxide from precipitating, but weakly enough to give up the metal ion when EDTA is added.
IV. It is used to permit many metals to be titrated in alkaline solution with EDTA.
I only
II and III
II, III, and IV
III, and IV
I, II, III and IV
Identify the sample of the above question with USP requirement of:
Persia oil 90-108
Corn oil 102-128
Olive oil 79-88
None of the choices
Military standard table is also known as:
Government sampling plan
MIL-STD-105D
ABC-STD 105D
All of the choices
If 10g of olive oil required 20 mL of 0.0211 N NaOH in the titration of the free fatty acids. What is the acid number of the oil?
2.9
2.4
11.50
115
A sample of Chlorpheniramine maleate weighing 0.502 g was assayed by nonaqueous titrimetry using 22.2 mL of perchloric acid with normality of 0.1125. Calculate the % purity of the sample. Each mL of 0.1 N perchloric acid is equivalent to 19.54 mg of C16H19CLN2. C4H4O4
97.2
72.9
27.9
9.72
The end point of using number ferric ammonium sulfate is:
White precipitate
Red-brown color
Pink color
Blue color
Orthophenanthroline TS is used as indicator in
Permanganometry
Ceric sulfate titration
Iodometry
Iodimetry
Which of the following statement/s is/are correct
I. Iodine value is a quantitative measure of the amount of unsaturated fatty acid in fats.
II. Method I of determining iodine value is also known as Hanus method.
III. Wij’s method is also a method of determining iodine value.
IV. Hubl’s method is official method of determining iodine value.
I only
I and II
I, II and III
All of the statements are correct
Determine the iodine value of an unknown sample of oil weighing 0.21g if 26mL and 12 mL of 0.1100 N of sodium thiosulfate are required for the blank and residual titration respectively.
90
93
108
200
Method 1 for determining alcohol-soluble extractives is also known as:
Hot extraction method
Cold extraction method
Hot compressed method
Cold compressed method
Primary standard used to standardized Karl Fischer reagent is:
Anhydrous sodium carbonated
Sodium tartrate
Potassium hydrogen phthalate
Sodium oxalate
Residue on ignition is also called:
Loss on ignition
Loss on drying
Acid-soluble ash
Sulfated ash
The type of alkaliodal assay where the total alkaloid is determined.
Ultimate
Specific
Proximate
Extraction
What weight of arsenic trioxide (93.73%) would be used as a sample so that 26.6 mL of 0.1120 N iodine would be needed to titrate it? MW = 197.46
0.14896 g
0.4896 g
0.1111 g
0.9145 g
Iodimetry is an indirect analysis of:
Oxidizing agent
Reducing agent
Acid
Base
When a reducing analyte is titrated directly with iodine, the method used is called
Iodometry
Iodimetry
Cerimetry
Permanganometry
Also known as Eosin Y.
Dichlorofluorescein
Tetrabromophenolpthalein
Tetrabromofluorescein
Xylenol orange
The above solution (question no.61) has a density of 1.454 g/mL. Find the molality of methanol.
0.87
0.77
8.7
7.7
The molarity of concentrated HCl purchased in the laboratory is approximately 12.1 M. How many mL of this reagent should be diluted to 2 L to make 0.1 M?
1.65
6.53
16.53
165.3
The Kjeldahl procedure was used to analyzed 256μL of a solution containing 37.9 mg protein/mL. The liberated ammonia was collected in 5 mL of 0.0336 M HCl, and the remaining acid required 6.34 mL of 0.010 M NaOH for complete titration. What is the weight % of nitrogen in the protein? MW= 14
3.86
15.1
51.5
5.65
A 10 mL sample of sulfuric acid solution required 16.85 mL of NaOH solution in a titration. Each mL of the NaOH solution was equivalent to 0.2477 g of potassium hydrogen phthalate. Calculate the sulfuric acid content in %w/v. MW=98
10%
20%
30%
40%
What is the titer value for 0.05 M calcium chloride with 2 moles of water? MW= 142.9
3.57 mg
7.15 mg
73.5 mg
53.7 mg
A 4.59 mL sample of HCl, specific gravity 1.3, required 50.5 mL of 0.9544N NaOH in a titration. Calculate the % w/w HCl.
29%
1%
92%
69%
A 0.2185 g sample of NaCl was assayed using Volhard method using 50 mL of 0.998N silver nitrate and 11.9 mL of 0.1350N ammonium thiocyanate. Calculate the NaCl in the sample. MW NaCl = 58.45
42.6
62.4
90.5
Sulfamic acid (H3NSO3) is a primary standard that can be used to standardized sodium
hydroxide. What is the molarity if 33.26 mL reacts with 0.3337 g sulfamic acid. MW=97Sulfamic acid (H3NSO3) is a primary standard that can be used to standardized sodium hydroxide. What is the molarity if 33.26 mL reacts with 0.3337 g sulfamic acid. MW=97
0.304
0.1004
0.1005
0.403
To keep samples moisture free, the appropriate apparatus to use is:
Desiccator
Separatory funnel
Furnace
Incubator
The used of sodium bicarbonate in the standardization of iodine solution ______.
Increase the solubility
as buffer
As preservative
To prevent bacterial growth
When a weak base is to be titrated with weak acid, the indicator used is:
Phenolphthalein
Methyl orange
Methyl red
No indicator is suggested
The use of chloroform in sodium thiosulfate solution.
To stabilize the solution
To increase its solubility
To prevent bacterial growth
To maintain pH of the solution
Standard solutions in nonaqueous alkalimetry.
I. Lithium methoxide
II. Perchloric acid
III. Hydrogen bromide
IV. Sodium hydroxide
I only
I and II only
I, II, and III only
I, II, III and IV
Indicator/s used in nonaqueous titrimetry
I. Nile blue
II. Crystal violet
III. Malachite green
IV. Phenolphthalein
I only
I and II only
I, II, and III only
I, II, III and IV
Which of the following statement/s is/are correct?
I. Non-aqueous alkalimetry is used when the analyte is weakly acidic
II. Non-aqueous alkalimetry is used when analyte is acid halide.
III. Non-aqueous alkalimetry is used when the analyte contains heterocyclic nitrogen compound.
IV. Non-aqueous alkalimetry is used when analyte is barbiturate.
I only
I and II only
I, II, and III only
I, II, and IV
Most suitable indicator to use in titration of organic acids
Methyl red TS
Methyl orange TS
Phenolphthalein
All of the choices
Developed in 1883, this method of analysis remains as one of the accurate and widely used method for determining nitrogen in substance.
Non-aqueous titrimetry
Precipitation
Redox titration
Kjeldahl method
The equilibrium constant for the reaction of the metal ion with a ligand is called _____.
Formation constant
Solubility product constant
Solubility constant
None of the choices
NaCl ______ the stability of EDTA complex.
Increases
Decreases
No effect
None of the choices
The reaction between HCl and calcium carbonate can be seen in the standardization of:
Silver nitrate
Ammonium thiocyanate
Edetate disodium
Sulfuric acid
Indicator in iodometric method of analysis.
KMnO4
Methyl red TS
Methyl orange TS
Starch TS
In the standardization of iodine solution, why is there a need to boil the solution of arsenic trioxide?
it increases the solubility
it makes the solution stable
none of the choices
Primary standard in the standardization of ceric sulfate solution
potassium hydrogen phthalate
calcium carbonate
sodium bicarbonate
arsenic trioxide
Other name of ferrous phenanthroline.
eosin Y
crystal violet
ferroin
ferric alum
Use of KI in the preparation of iodine solution.
Solubilizing agent
Change in pH of the solution
As preservative
All of the choices
Standards solutions are also known as:
test solutions
volumetric solutions
saturated solution
none of the choices
Which of the following is added to maintain the pH of sodium thiosulfate in optimum range for the stability of the solution?
Sodium bicarbonate
Chloroform
Thymol
Sodium carbonate
Limit moisture in nonaqueous titrimetric analysis is less than:
0.5 %
0.05 %
0.2 %
0.02 %
Other name of systematic error
Determinate
Indeterminate
Random
Primary standard in the standardization of perchloric acid
Potassium hydrogen phthalate
Calcium carbonate
Benzoic acid
Sodium carbonate
Describes how close a measured value is to the true value.
Accuracy
Precision
Range
Standard deviation
Solutions containing all the reagents and solvents used in the analysis, but no deliberately added analyte.
Blank solution
Solution with sample
Standard solution
Test solution
Reasons why residual titration are performed.
Reaction proceeds slowly
Poor solubility of the sample
Sample does not give sharp end point
All of the choices
Fajans titration uses ____ indicator.
Acid-base
Adsorption
Metal-ion
None of the choices
Argentometric titration is titration with ______ ion.
Magnesium
Sodium
Silver
Potassium
Standard solution in precipitation method of analysis
Disodium edetate
Silver nitrate
Sodium Methoxide
Perchloric acid
Assay of diluted HCl is expressed in:
% w/w
% w/v
The following is/are example/s of metal-ion indicators.
I. Murexide
II. Calmagite
III. Pyrocathecol violet
IV. Ferric alum
I only
I and II only
I, II, and III
I, II, III and IV
Methyl orange in base medium is colored:
Yellow
Pink
Colorless
Green
Performs and evaluate microbiological assay, sterility, pyrogen, and bacteriological test, safety or acute toxicity test.
Material inspection section
Analytical laboratory
Biological testing
Specification and analytical laboratory
The end point of iodometry using starch TS as indicator is:
Intense blue color
Disappearance of blue color
Greenish-blue color
Disappearance of green-blue color
Hexane is the best solvent extracting:
Resins
Fats
Volatile oil
Acid
The unsaponifiable matter present in vegetable oils and fats is:
Cholesterol
Cellulose
Phytosterol
Lard
Assay of ASA (raw material) is an example of what method of analysis?
Direct alkalimetry
Residual alkalimetry
Direct acidimetry
Residual acidimetry
The bacterial structure responsible for selective permeability is:
Cell wall
Fimbriae
Spore
Cytoplasmic membrane
The type of container which is impervious to air or any other gas under the ordinary or customary conditions of handling, shipping, storage and distribution.
Tight-container
Well-closed container
Single-unit container
Hermetic container
It is the partial or complete separation of the top or bottom of a tablet from the main body
Lamination
Capping
Mottling
Picking
A critical defect that would stop the packaging line operations:
Wrong labels
Misaligned labels
Inverted labels
Smeared labels
Which question is used to predict the shelf life of a drug product?
Michaelis-Menten equation
Arrhenius theory
Hixson-Crowell equation
Stokes equation
The dye used in the leaker test
Methylene blue
Phenolphthalein
Thymol blue
None of the above
A defect that may affect the function of an object and therefore, may render the product useless.
Major defect
Critical defect
Minor defect
Ocular defect
Powdered glass test is done on the following except
Borosilicate glass
Soda lime glass
Treated soda lime glass
General purpose soda lime glass
Biological reactivity test(s) in vitro except
Agar diffusion test
Direct contact test
Implantation testm
Elution test
One of the following is a secondary packaging component:
Caps
Corrugated cartons
Vials
Bottles
Content uniformity test is used to ensure which of the following quality in tablet products:
Disintegration
Purity
Bioavailability
Potency
Pyrogen test is performed in:
Pigeons
Mice
Rabbits
Guinea pigs
In disintegration, enteric-coated tablets must
Show no evidence to disintegration after 30 minutes in simulated gastric fluid
Show no evidence to disintegration after 30 minutes in simulated intestinal fluid
In simulated intestinal fluid, they should disintegrate in 2 hours plus the time specified
In simulated gastric fluid, they should disintegrate in 2 hours plus in time specified
In validation procedures the ability to assess unequivocally the analyte in the presence of components that may be expected to be present is called
Precision
Accuracy
Specificity
None of the above
Air particle counts in clean rooms is base on what particle size
0.5 μm
0.2 μm
1 μm
None of the above
Which of the following is not an official hard gelatin capsule size for human consumption
000
00
0000
None of the above
What tablet attribute is correlated with the biological availability of the active ingredient.
Disintegration
Dissolution
Content uniformity
None of the above
The quality of water recommended in the preparation of compendial dosage forms is
Deionized water
Distilled water
Purified water
Water for injection
All of the following are optical devices except:
pH meter
Spectrophotometer
Colorimeter
Filter photometer
Beer’s plot in spectrometry is prepared to determine:
Absorbance of the sample
Wavelength to be used
Blank
Concentration of the drug substance
When packaging and storage requirements specifies a “tight container” it is understood that;
Contents are protected from extraneous solids
Contents are protected from extraneous solids and liquids
Contents are protected from extraneous solids, liquids and vapors
Contents are protected from extraneous solids, liquids, vapors and gas
The suitability of plastic materials intended for use as a container of drug products is determined through what type of test?
Biological Reactivity Test, In Vitro
Biological Reactivity Test, In Vivo
The classification plastic materials intended for use as a container of drug products is determined through what type of test?
Biological Reactivity Test, In Vitro
Biological Reactivity Test, In Vivo
The reference microorganism for testing the retention efficiency of a sterilizing filter is
Pseudomonas aeruginosa
Pseudomonas diminuta
E. coli
None of the above
