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Quality Assurance and Quality Control Part I

Total questions: 100

Worksheet time: 4hrs 30mins

Name
Class
Date
1.

A buret with a glass stopcock can be used for:

a)

Alcohols

b)

Acids

c)

Bases

2.

Bleeding is a main stability problem seen in

a)

Capsules

b)

Emulsions

c)

Ointments

d)

Tablets

3.

To keep samples moisture-free the apparatus used is:

a)

Desiccator

b)

Furnace

c)

Incubator

d)

Oven

4.

In neutralization methods in aqueous medium, a product is:

a)

Oil

b)

Salt

c)

Precipitate

5.

The instrument used to measure the optical activity of the sample is:

a)

Refractometer

b)

Polarimeter

c)

Spectrometer

d)

Flame photometer

6.

Assay of zinc oxide is what type of analysis?

a)

Alkalimetric residual

b)

Acidimetric direct

c)

Acidimetric residual

d)

Alkalimetric direct

7.

Titer is an expression of concentration of solution is determined.

a)

g of solute/ 100 mL

b)

g or mg/mL

c)

g of solute / L

8.

Which of the following chemicals is not included in preparing the Karl Fischer reagent?

a)

Pyridine

b)

Acetone

c)

Sulfur dioxide

d)

Iodine

9.

To remove stain of KMnO4, the most effective chemical substance is :

a)

Oxalic acid

b)

Sodium thiosulfate

c)

Vinegar

d)

Bromine solution

10.

The primary standard used in the standardization of the above VS is:

a)

Sodium carbonate

b)

Sodium bicarbonate

c)

Potassium biphthalate

d)

Benzoic acid

11.

To determine the total ash, the sample is incinerated at a temperature of 675 + - 25°C. This temperature is represented by:

a)

Very dull heat

b)

Dull red heat

c)

White red heat

d)

Bright red heat

12.

Method II of determining iodine value is also known as:

a)

Hub’s method

b)

Wij’s method

c)

Hanus method

d)

All of the choices

13.

Dichlorophenol-indophenol solution is standardized using:

a)

Sulfanilamide USP

b)

Ascorbic acid USP

c)

Sulfathiazole USP

d)

Resorcinol USP

14.

Koppeschaar’s solution is also known as:

a)

0.1 N Iodine solution

b)

0.1 N Bromine solution

c)

0.1 M sodium nitrite solution

d)

0.1 N sodium thiosulfate solution

15.

The following is/ are true about EDTA titration.

I. EDTA titration is also known as complexometric titration.

II. The equilibrium constant in EDTA titration is called EDTA indicator.

III. For end-point detection, commonly used indicator is called EDTA indicator

IV. EDTA titration technique includes displacement titration.

a)

I only

b)

II and III

c)

I, II, and III

d)

I, II and IV

e)

I, II, III and IV

16.

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.

a)

I only

b)

II and III

c)

II, III, and IV

d)

III, and IV

e)

I, II, III and IV

17.

Identify the sample of the above question with USP requirement of:

a)

Persia oil 90-108

b)

Corn oil 102-128

c)

Olive oil 79-88

d)

None of the choices

18.

Military standard table is also known as:

a)

Government sampling plan

b)

MIL-STD-105D

c)

ABC-STD 105D

d)

All of the choices

19.

If 10g of olive oil required 20 mL of 0.0211 N NaOH in the titration of the free fatty acids. What is the acid number of the oil?

a)

2.9

b)

2.4

c)

11.50

d)

115

20.

A sample of Chlorpheniramine maleate weighing 0.502 g was assayed by nonaqueous titrimetry using 22.2 mL of perchloric acid with normality of 0.1125. Calculate the % purity of the sample. Each mL of 0.1 N perchloric acid is equivalent to 19.54 mg of C16H19CLN2. C4H4O4

a)

97.2

b)

72.9

c)

27.9

d)

9.72

21.

The end point of using number ferric ammonium sulfate is:

a)

White precipitate

b)

Red-brown color

c)

Pink color

d)

Blue color

22.

Orthophenanthroline TS is used as indicator in

a)

Permanganometry

b)

Ceric sulfate titration

c)

Iodometry

d)

Iodimetry

23.

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.

a)

I only

b)

I and II

c)

I, II and III

d)

All of the statements are correct

24.

Determine the iodine value of an unknown sample of oil weighing 0.21g if 26mL and 12 mL of 0.1100 N of sodium thiosulfate are required for the blank and residual titration respectively.

a)

90

b)

93

c)

108

d)

200

25.

Method 1 for determining alcohol-soluble extractives is also known as:

a)

Hot extraction method

b)

Cold extraction method

c)

Hot compressed method

d)

Cold compressed method

26.

Primary standard used to standardized Karl Fischer reagent is:

a)

Anhydrous sodium carbonated

b)

Sodium tartrate

c)

Potassium hydrogen phthalate

d)

Sodium oxalate

27.

Residue on ignition is also called:

a)

Loss on ignition

b)

Loss on drying

c)

Acid-soluble ash

d)

Sulfated ash

28.

The type of alkaliodal assay where the total alkaloid is determined.

a)

Ultimate

b)

Specific

c)

Proximate

d)

Extraction

29.

What weight of arsenic trioxide (93.73%) would be used as a sample so that 26.6 mL of 0.1120 N iodine would be needed to titrate it? MW = 197.46

a)

0.14896 g

b)

0.4896 g

c)

0.1111 g

d)

0.9145 g

30.

Iodimetry is an indirect analysis of:

a)

Oxidizing agent

b)

Reducing agent

c)

Acid

d)

Base

31.

When a reducing analyte is titrated directly with iodine, the method used is called

a)

Iodometry

b)

Iodimetry

c)

Cerimetry

d)

Permanganometry

32.

Also known as Eosin Y.

a)

Dichlorofluorescein

b)

Tetrabromophenolpthalein

c)

Tetrabromofluorescein

d)

Xylenol orange

33.

The above solution (question no.61) has a density of 1.454 g/mL. Find the molality of methanol.

a)

0.87

b)

0.77

c)

8.7

d)

7.7

34.

The molarity of concentrated HCl purchased in the laboratory is approximately 12.1 M. How many mL of this reagent should be diluted to 2 L to make 0.1 M?

a)

1.65

b)

6.53

c)

16.53

d)

165.3

35.

The Kjeldahl procedure was used to analyzed 256μL of a solution containing 37.9 mg protein/mL. The liberated ammonia was collected in 5 mL of 0.0336 M HCl, and the remaining acid required 6.34 mL of 0.010 M NaOH for complete titration. What is the weight % of nitrogen in the protein? MW= 14

a)

3.86

b)

15.1

c)

51.5

d)

5.65

36.

A 10 mL sample of sulfuric acid solution required 16.85 mL of NaOH solution in a titration. Each mL of the NaOH solution was equivalent to 0.2477 g of potassium hydrogen phthalate. Calculate the sulfuric acid content in %w/v. MW=98

a)

10%

b)

20%

c)

30%

d)

40%

37.

What is the titer value for 0.05 M calcium chloride with 2 moles of water? MW= 142.9

a)

3.57 mg

b)

7.15 mg

c)

73.5 mg

d)

53.7 mg

38.

A 4.59 mL sample of HCl, specific gravity 1.3, required 50.5 mL of 0.9544N NaOH in a titration. Calculate the % w/w HCl.

a)

29%

b)

1%

c)

92%

d)

69%

39.

A 0.2185 g sample of NaCl was assayed using Volhard method using 50 mL of 0.998N silver nitrate and 11.9 mL of 0.1350N ammonium thiocyanate. Calculate the NaCl in the sample. MW NaCl = 58.45

a)

42.6

b)

62.4

c)

90.5

40.

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

a)

0.304

b)

0.1004

c)

0.1005

d)

0.403

41.

To keep samples moisture free, the appropriate apparatus to use is:

a)

Desiccator

b)

Separatory funnel

c)

Furnace

d)

Incubator

42.

The used of sodium bicarbonate in the standardization of iodine solution ______.

a)

Increase the solubility

b)

as buffer

c)

As preservative

d)

To prevent bacterial growth

43.

When a weak base is to be titrated with weak acid, the indicator used is:

a)

Phenolphthalein

b)

Methyl orange

c)

Methyl red

d)

No indicator is suggested

44.

The use of chloroform in sodium thiosulfate solution.

a)

To stabilize the solution

b)

To increase its solubility

c)

To prevent bacterial growth

d)

To maintain pH of the solution

45.

Standard solutions in nonaqueous alkalimetry.

I. Lithium methoxide

II. Perchloric acid

III. Hydrogen bromide

IV. Sodium hydroxide

a)

I only

b)

I and II only

c)

I, II, and III only

d)

I, II, III and IV

46.

Indicator/s used in nonaqueous titrimetry

I. Nile blue

II. Crystal violet

III. Malachite green

IV. Phenolphthalein

a)

I only

b)

I and II only

c)

I, II, and III only

d)

I, II, III and IV

47.

Which of the following statement/s is/are correct?

I. Non-aqueous alkalimetry is used when the analyte is weakly acidic

II. Non-aqueous alkalimetry is used when analyte is acid halide.

III. Non-aqueous alkalimetry is used when the analyte contains heterocyclic nitrogen compound.

IV. Non-aqueous alkalimetry is used when analyte is barbiturate.

a)

I only

b)

I and II only

c)

I, II, and III only

d)

I, II, and IV

48.

Most suitable indicator to use in titration of organic acids

a)

Methyl red TS

b)

Methyl orange TS

c)

Phenolphthalein

d)

All of the choices

49.

Developed in 1883, this method of analysis remains as one of the accurate and widely used method for determining nitrogen in substance.

a)

Non-aqueous titrimetry

b)

Precipitation

c)

Redox titration

d)

Kjeldahl method

50.

The equilibrium constant for the reaction of the metal ion with a ligand is called _____.

a)

Formation constant

b)

Solubility product constant

c)

Solubility constant

d)

None of the choices

51.

NaCl ______ the stability of EDTA complex.

a)

Increases

b)

Decreases

c)

No effect

d)

None of the choices

52.

The reaction between HCl and calcium carbonate can be seen in the standardization of:

a)

Silver nitrate

b)

Ammonium thiocyanate

c)

Edetate disodium

d)

Sulfuric acid

53.

Indicator in iodometric method of analysis.

a)

KMnO4

b)

Methyl red TS

c)

Methyl orange TS

d)

Starch TS

54.

In the standardization of iodine solution, why is there a need to boil the solution of arsenic trioxide?

a)

it increases the solubility

b)

it makes the solution stable

c)

none of the choices

55.

Primary standard in the standardization of ceric sulfate solution

a)

potassium hydrogen phthalate

b)

calcium carbonate

c)

sodium bicarbonate

d)

arsenic trioxide

56.

Other name of ferrous phenanthroline.

a)

eosin Y

b)

crystal violet

c)

ferroin

d)

ferric alum

57.

Use of KI in the preparation of iodine solution.

a)

Solubilizing agent

b)

Change in pH of the solution

c)

As preservative

d)

All of the choices

58.

Standards solutions are also known as:

a)

test solutions

b)

volumetric solutions

c)

saturated solution

d)

none of the choices

59.

Which of the following is added to maintain the pH of sodium thiosulfate in optimum range for the stability of the solution?

a)

Sodium bicarbonate

b)

Chloroform

c)

Thymol

d)

Sodium carbonate

60.

Limit moisture in nonaqueous titrimetric analysis is less than:

a)

0.5 %

b)

0.05 %

c)

0.2 %

d)

0.02 %

61.

Other name of systematic error

a)

Determinate

b)

Indeterminate

c)

Random

62.

Primary standard in the standardization of perchloric acid

a)

Potassium hydrogen phthalate

b)

Calcium carbonate

c)

Benzoic acid

d)

Sodium carbonate

63.

Describes how close a measured value is to the true value.

a)

Accuracy

b)

Precision

c)

Range

d)

Standard deviation

64.

Solutions containing all the reagents and solvents used in the analysis, but no deliberately added analyte.

a)

Blank solution

b)

Solution with sample

c)

Standard solution

d)

Test solution

65.

Reasons why residual titration are performed.

a)

Reaction proceeds slowly

b)

Poor solubility of the sample

c)

Sample does not give sharp end point

d)

All of the choices

66.

Fajans titration uses ____ indicator.

a)

Acid-base

b)

Adsorption

c)

Metal-ion

d)

None of the choices

67.

Argentometric titration is titration with ______ ion.

a)

Magnesium

b)

Sodium

c)

Silver

d)

Potassium

68.

Standard solution in precipitation method of analysis

a)

Disodium edetate

b)

Silver nitrate

c)

Sodium Methoxide

d)

Perchloric acid

69.

Assay of diluted HCl is expressed in:

a)

% w/w

b)

% w/v

70.

The following is/are example/s of metal-ion indicators.

I. Murexide

II. Calmagite

III. Pyrocathecol violet

IV. Ferric alum

a)

I only

b)

I and II only

c)

I, II, and III

d)

I, II, III and IV

71.

Methyl orange in base medium is colored:

a)

Yellow

b)

Pink

c)

Colorless

d)

Green

72.

Performs and evaluate microbiological assay, sterility, pyrogen, and bacteriological test, safety or acute toxicity test.

a)

Material inspection section

b)

Analytical laboratory

c)

Biological testing

d)

Specification and analytical laboratory

73.

The end point of iodometry using starch TS as indicator is:

a)

Intense blue color

b)

Disappearance of blue color

c)

Greenish-blue color

d)

Disappearance of green-blue color

74.

Hexane is the best solvent extracting:

a)

Resins

b)

Fats

c)

Volatile oil

d)

Acid

75.

The unsaponifiable matter present in vegetable oils and fats is:

a)

Cholesterol

b)

Cellulose

c)

Phytosterol

d)

Lard

76.

Assay of ASA (raw material) is an example of what method of analysis?

a)

Direct alkalimetry

b)

Residual alkalimetry

c)

Direct acidimetry

d)

Residual acidimetry

77.

The bacterial structure responsible for selective permeability is:

a)

Cell wall

b)

Fimbriae

c)

Spore

d)

Cytoplasmic membrane

78.

The type of container which is impervious to air or any other gas under the ordinary or customary conditions of handling, shipping, storage and distribution.

a)

Tight-container

b)

Well-closed container

c)

Single-unit container

d)

Hermetic container

79.

It is the partial or complete separation of the top or bottom of a tablet from the main body

a)

Lamination

b)

Capping

c)

Mottling

d)

Picking

80.

A critical defect that would stop the packaging line operations:

a)

Wrong labels

b)

Misaligned labels

c)

Inverted labels

d)

Smeared labels

81.

Which question is used to predict the shelf life of a drug product?

a)

Michaelis-Menten equation

b)

Arrhenius theory

c)

Hixson-Crowell equation

d)

Stokes equation

82.

The dye used in the leaker test

a)

Methylene blue

b)

Phenolphthalein

c)

Thymol blue

d)

None of the above

83.

A defect that may affect the function of an object and therefore, may render the product useless.

a)

Major defect

b)

Critical defect

c)

Minor defect

d)

Ocular defect

84.

Powdered glass test is done on the following except

a)

Borosilicate glass

b)

Soda lime glass

c)

Treated soda lime glass

d)

General purpose soda lime glass

85.

Biological reactivity test(s) in vitro except

a)

Agar diffusion test

b)

Direct contact test

c)

Implantation testm

d)

Elution test

86.

One of the following is a secondary packaging component:

a)

Caps

b)

Corrugated cartons

c)

Vials

d)

Bottles

87.

Content uniformity test is used to ensure which of the following quality in tablet products:

a)

Disintegration

b)

Purity

c)

Bioavailability

d)

Potency

88.

Pyrogen test is performed in:

a)

Pigeons

b)

Mice

c)

Rabbits

d)

Guinea pigs

89.

In disintegration, enteric-coated tablets must

a)

Show no evidence to disintegration after 30 minutes in simulated gastric fluid

b)

Show no evidence to disintegration after 30 minutes in simulated intestinal fluid

c)

In simulated intestinal fluid, they should disintegrate in 2 hours plus the time specified

d)

In simulated gastric fluid, they should disintegrate in 2 hours plus in time specified

90.

In validation procedures the ability to assess unequivocally the analyte in the presence of components that may be expected to be present is called

a)

Precision

b)

Accuracy

c)

Specificity

d)

None of the above

91.

Air particle counts in clean rooms is base on what particle size

a)

0.5 μm

b)

0.2 μm

c)

1 μm

d)

None of the above

92.

Which of the following is not an official hard gelatin capsule size for human consumption

a)

000

b)

00

c)

0000

d)

None of the above

93.

What tablet attribute is correlated with the biological availability of the active ingredient.

a)

Disintegration

b)

Dissolution

c)

Content uniformity

d)

None of the above

94.

The quality of water recommended in the preparation of compendial dosage forms is

a)

Deionized water

b)

Distilled water

c)

Purified water

d)

Water for injection

95.

All of the following are optical devices except:

a)

pH meter

b)

Spectrophotometer

c)

Colorimeter

d)

Filter photometer

96.

Beer’s plot in spectrometry is prepared to determine:

a)

Absorbance of the sample

b)

Wavelength to be used

c)

Blank

d)

Concentration of the drug substance

97.

When packaging and storage requirements specifies a “tight container” it is understood that;

a)

Contents are protected from extraneous solids

b)

Contents are protected from extraneous solids and liquids

c)

Contents are protected from extraneous solids, liquids and vapors

d)

Contents are protected from extraneous solids, liquids, vapors and gas

98.

The suitability of plastic materials intended for use as a container of drug products is determined through what type of test?

a)

Biological Reactivity Test, In Vitro

b)

Biological Reactivity Test, In Vivo

99.

The classification plastic materials intended for use as a container of drug products is determined through what type of test?

a)

Biological Reactivity Test, In Vitro

b)

Biological Reactivity Test, In Vivo

100.

The reference microorganism for testing the retention efficiency of a sterilizing filter is

a)

Pseudomonas aeruginosa

b)

Pseudomonas diminuta

c)

E. coli

d)

None of the above