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PINK QA & QC-2

Total questions: 118

Worksheet time: 59mins

Name
Class
Date
1.

1 N HCl VS can be standardized using:

a)

Sodium bicarbonate

b)

Potassium phthalate

c)

Sodium oxalate

d)

Tromethamine

2.

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

3.

Residual titration method is also known as:

a)

Direct titration

b)

Indirect titration

c)

Back titration

d)

Redox titration

4.

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

5.

The standard substance used in checking the cleanliness of Abbe refractometer by determining its refractive index is:

a)

Rose oil

b)

Water

c)

Methanol

d)

Peanut oil

6.

Coulometric titration of water determination is also known as:

a)

Method I c

b)

Method II

c)

Method I a

d)

Method III

7.

Perchloric acid in glacial acetic acid and perchloric acid in dioxane are volumetric solution used in what type of analysis?

a)

Direct acidimetry

b)

Direct alkalimetry

c)

Non-aqueous acidimetry

d)

Non-aqueous alkalimetry

8.

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

a)

Sodium carbonate

b)

Sodium bicarbonate

c)

Potassium biphtalate

d)

Benzoic acid

9.

Which of the following statement/s is/are true? I. Phenol is assayed using residual iodometry using excess bromine solution. II. 0.1 N Bromine solution contains potassium bromide and potassium bromate. III. Bromine vapor is liberated from KBr and KBrO3 in basic environment.

a)

I only

b)

I and II only

c)

I, II, and III

d)

None of the choices

10.

A 1.5 g of liquefied phenol was dissolved in enough water to make 1000 mL. A 30 mL sample of the solution was treated with 30 mL of 0.1 N bromine solution and HCl. The mixture was treated with KI and titrated with 8.7 mL of 0.1 N sodium thiosulfate. It was also found that 21 mL of 0.1 N sodium thiosulfate was required in the titration of the iodine liberated when 20 mL of the bromine solution was treated with KI and HCl. Compute for the percent phenol in the sample. MW phenol = 94.

a)

59.4

b)

69.4

c)

79.4

d)

89.4

11.

Hydrolysis products of ASA are:

a)

Acetic acid + sodium hydroxide

b)

Acetic acid + salicylic acid

c)

Salicylic acid + sodium hydroxide

d)

Sodium salicylate + water

12.

The measurement of a base of a given sample by titration of standard acid is:

a)

Acidimetry

b)

Alkalimetry

c)

Compleximetry

d)

Redox titration

13.

A characteristic of a substance which is suitable for non-aqueous titrimetry is:

a)

Weakly reactive

b)

Weakly basic

c)

Very soluble in water

d)

a and b

e)

b and c

14.

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

a)

Oxalic acid

b)

Sodium thiosulfate

c)

Vinegar

d)

Bromine solution

15.

The oxidation number of Mn in KMnO4 is:

a)

+2

b)

+1

c)

+5

d)

+7

16.

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

a)

Pyridine

b)

Acetone

c)

Sulfur dioxide

d)

Iodine

17.

The process in which the exact concentration of solution is determined.

a)

Neutralization

b)

Standardization

c)

Titration

d)

Complexation

18.

Titer is an expression of concentration of solution is determined.

a)

g of solute/100 mL

b)

g or mg/mL

c)

g of solute/L

d)

b and c

19.

Methyl orange in base medium is colored:

a)

Yellow

b)

Pink

c)

Colorless

d)

Green

20.

Assay of zinc oxide is what type of analysis?

a)

Alkalimetric residual

b)

Acidimetric direct

c)

Acidimetric residual

d)

Alkalimetric direct

21.

The indicator used if weak acid is titrated with strong alkali is:

a)

Methyl orange

b)

Methyl red

c)

Phenol red

d)

Phenolphthalein

22.

Phenolphthalein in alkali medium is colored:

a)

Yellow

b)

Pink

c)

Colorless

d)

Blue

23.

Suppository that does not melt at body temperature is what kind of defect?

a)

Major

b)

Critical

c)

Minor

d)

Performance

24.

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

25.

This analysis is done by dissolving the substance under examination in an accurately measured quantity of standard solution known to be in excess and back titrating the excess solution with another standard solution.

a)

Gravimetric analysis

b)

Acidimetric analysis

c)

Direct alkalimetric analysis

d)

Residual titration

26.

When the alcoholic KOH is used to neutralize the acid and saponify the ester of 1 g of the oil or fat, the constant determined is:

a)

Acid value

b)

Ester value

c)

Hydroxyl value

d)

Saponification value

27.

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

a)

Refractometer

b)

Polarimeter

c)

Spectrometer

d)

Flame photometer

28.

Analysis in which separation of the constituents from the sample is done and then weighing the product is:

a)

Volumetric analysis

b)

Instrumental method of analysis

c)

Gravimetric analysis

d)

Special method of analysis

29.

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

30.

Which of the following statement/s is/are correct? I. Ester value is the number of mg of KOH required to saponify the ester in 1 g of fat or oil. II. Ester value = saponification value + Acid value. III. Ester value determination is applicable to fats, volatile oils, and alcohols.

a)

I only

b)

I and II only

c)

I, II, and III

d)

All of the statements are incorrect

31.

Which of the following area is not a responsibility of quality control manager?

a)

Specification and analytical development

b)

Biological testing lab

c)

Analytical lab

d)

Market research

32.

Hexane is the best solvent extracting:

a)

Resins

b)

Fats

c)

Volatile oil

d)

Acid

33.

What is the other name of Koettsdorfer number?

a)

Acid value

b)

Saponification value

c)

Ester value

d)

Iodine value

34.

The unsaponifiable matter present in animal fats is:

a)

Cholesterol

b)

Phytosterol

c)

Lard

d)

Wax

35.

The crude fiber of a drug usually consist of:

a)

Cellulose

b)

Cholesterol

c)

Phytosterol

d)

All of the choices

36.

The unsaponifiable matter present in vegetable oils and fats is:

a)

Cholesterol

b)

Cellulose

c)

phytosterol

d)

lard

37.

If a 0.47 g sample of potassium iodide yielded 0.7564 g of silver iodide precipitate by gravimetric assay, compute for the percent purity of the potassium iodide. MW KI = 165.90; MW AgI = 234.76.

a)

83.7%

b)

93.7%

c)

103.7%

d)

113.7%

38.

Which of the following volumetric solutions is used in diazotization analysis of sulfa drugs?

a)

0.1 M sodium nitrite

b)

0.05 edetate disodium

c)

0.01 M sodium nitrite

d)

0.1 N Iodine solution

39.

Calculate the molarity of sodium nitrite volumetric solution, if 31.6 mL of this solution reacts with 0.5004 g of sulfanilamide (C6H8N2O2S) to reach an end point. MW of sulfanilamide = 172.2

a)

0.09196

b)

0.91960

c)

0.21090

d)

0.01209

40.

A 0.5110 g sample of sulfathiozole was assayed using 18.8 mL of 0.1005 M sodium nitrite solution in a titration. Each mL of 0.1 M sodium nitrite is equivalent to 25.53 mg of C9H9N3O2S2. Calculate the % C9H9N3O2S2 in the sample.

a)

99%

b)

95%

c)

94%

d)

93%

41.

Which of the following standard solutions is not used in redox titration?

a)

Sodium thiosulfate solution

b)

Iodine solution

c)

Bromine solution

d)

Sodium hydroxide solution

42.

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

43.

Assay of sodium nitrite is an example of what method of analysis?

a)

Direct titration – Redox

b)

Indirect titration – Redox

c)

Residual titration – Redox

d)

Iodimetry

44.

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)

Pharmacopoeial testing

d)

Pharmaceutical assaying

45.

Two substances reacting upon reaching the end point must have the same:

a)

Normality

b)

Volume

c)

Number of mEq

d)

Weight

46.

Most of the official drugs containing Calcium and Magnesium are determine by:

a)

Gravimetric

b)

Complexometry

c)

Bioassay

d)

Non-aqueous matter

47.

Type of titration used in volumetric analysis:

a)

Direct

b)

Residual

c)

Indirect

d)

All of the above

48.

The iodine value of an oil is a quantitative measure of:

a)

Phenol coefficient

b)

Saturated fatty acid

c)

Unsaturated fatty acid

d)

Unsaponifiable matter

49.

A sample of 0.1350 g of As2O3 was assayed iodimetrically using 23.4 mL of 0.1055 N iodine solution (atomic weight: As = 74.92, O = 16). The percentage purity of the sample is:

a)

90.44

b)

90.23

c)

89.0

d)

90.54

50.

Calculate the water content of streptomycin powder using a 3.50 g sample. The water equivalence factor, F, of the KF reagent was 4.6 and the volume consumed was 9.2 mL. The % water content was:

a)

1.20

b)

1.21

c)

12.10

d)

1.10

51.

Twenty tablets of Ascorbic acid weighed 4.250 g and a powdered sample of 0.3075 g used up 21.5 mL of 0.1085 N iodine solution. What was the amount of Ascorbic acid per dose of 2 tablets? Each mL of 0.1 N iodine is equivalent to 8.80 mg of C6H8O6 (Ascorbic Acid).

a)

283.7 mg

b)

141.86 mg

c)

0.2836 g

d)

A and C

52.

The primary staining reagent of the Gram procedure is:

a)

Methyl red

b)

Carbol fuchsin

c)

Crystal violet

d)

Saffranin

53.

The bacterial structure responsible for selective permeability is:

a)

Cell wall

b)

Fimbriae

c)

Spore

d)

Cytoplasmic membrane

54.

The measurement of a base of a given sample by titration with the standard acid is:

a)

Acidimetry

b)

Alkalimetry

c)

Complexometry

d)

Redox

55.

Analysis where separation of the constituent from the sample is done that weighing the products is:

a)

Volumetric

b)

Gravimetric

c)

Special

d)

Gasometric method

56.

Adsorption indicators are used in:

a)

Complexometric reaction

b)

Acidimetry

c)

Volumetric precipitation

d)

Alkalimetry

57.

Titer is an expression of concentration in terms of:

a)

g of solute per 100 mL

b)

g or mg of solute per mL

c)

g per liter

d)

A and C

58.

Iodimetry is what type of titration?

a)

Direct

b)

Indirect

c)

Residual

d)

A and C

59.

The type of alkaloidal assay where the total alkaloids are determines is:

a)

Ultimate

b)

Specific

c)

Proximate

d)

Precision

60.

To measure optical activity of a sample, the instrument used is:

a)

Polarimeter

b)

Refractometer

c)

Spectrometer

d)

Flame photometer

61.

The indicator for EDTA titration against CaCO3 is:

a)

Thymol blue

b)

Hydroxynaphthol blue

c)

Methyl red

d)

Methylene blue

62.

In neutralization methods in aqueous medium, a product is:

a)

Oil

b)

Salt

c)

Precipitate

d)

A and B

63.

The moisture content of a drug maybe:

a)

Water of hydration

b)

Water in the adsorbed form

c)

Water of crystallization

d)

All of the above

64.

The oxidation number of atomic iodine is:

a)

+1

b)

+2

c)

+4

d)

+3

65.

A spectrophotometer differs from a colorimeter is that it consists of:

a)

Prism

b)

Lamp house

c)

Cell compartment

d)

B and C

66.

The ash content of an organic compound is an impurity of:

a)

Prism

b)

Lamp house

c)

Oil

d)

Volatile oil

67.

To keep samples moisture-free the apparatus used is:

a)

Desiccator

b)

Furnace

c)

Incubator

d)

Oven

68.

Microbial assay of an antibiotics maybe performed using the following except:

a)

Test tube inoculation

b)

Cylinder plate method

c)

Paper disk method

d)

Titration process

69.

Result of the experiment that are close to one another is considered to be:

a)

Accurate

b)

Cylinder plate method

c)

Approximate

d)

A and C

70.

Flame Spectroscopy procedures maybe divided into:

a)

Flame emission

b)

Atomic adsorption

c)

Nuclear magnetic resonance

d)

A and B

71.

Safety and Toxicity test are conducted using:

a)

Rabbits

b)

Dogs

c)

White mice

d)

Guinea pig

72.

A parenteral is declared pyrogenic if the temperature rise in rabbits is:

a)

Less than 1.4°C in the 9 readings of the 3 rabbits

b)

0.6°C in the 1 of the 9 readings

c)

>1.4°C in the 9 readings of the 3 rabbits

d)

None of the above

73.

The ester value determination of substance is applicable to the following except:

a)

Fats

b)

Volatile oil

c)

Alcohols

d)

Fatty oils

74.

In Gas chromatography, the results of the assay is expressed in:

a)

Retention on the column

b)

Rf value

c)

Volume of the gas used

d)

Adsorbent

75.

The process by which the exact concentration of a solution is determined by:

a)

Neutralization

b)

Standardization

c)

Hydration

d)

Titration

76.

The infrared region of the spectrometer used to identify a substance uses a wavelength range of:

a)

3-5 μm

b)

380-780 μm

c)

200-380 μm

d)

15-300 μm

77.

The primary standard used to standardize Karl Fischer reagent is:

a)

Sodium carbonate anhydrous

b)

Potassium biphthalate

c)

sodium tartrate dihydrate

d)

sodium bicarbonate

78.

The molecular weight of sulfuric acid is 98. Its equivalent weight is:

a)

98

b)

49

c)

0.098

d)

0.049

79.

The type of ash where sulfuric acid used to whiten the ash is:

a)

acid insoluble ash

b)

sulfated ash

80.

The oil from peppermint can be determined by using:

a)

Cassia flask

b)

Bobcock bottle

c)

Pycometer

d)

Titration

81.

The molecular weight of NaOH is 40. How many grams of sodium hydroxide pellets are needed to make 500 mL of 1.5 N solution?

a)

20

b)

30

c)

40

d)

60

82.

Using a spectrophotometer to measure the concentration of a sample, the following data were obtained: absorbance (A) of the standard solution was 0.55; absorbance of the sample was 0.58. Concentration of the standard used was 16.5 mcg. The concentration of the sample was:

a)

15.5 mcg

b)

17.55 mcg

c)

17.40 mcg

d)

15.9 mcg

83.

Nephelometry is based on the measurement of light that is ______ by the particles of a suspension.

a)

Reflected

b)

Absorbed

c)

Transmitted

d)

Absorbed

84.

The type of chromatography where the cellulose of the filter paper is used as the adsorbent is:

a)

Column

b)

Paper

c)

TLC

d)

Gas

85.

All of the following are optical devices except:

a)

pH meter

b)

Spectrophotometer

c)

Colorimeter

d)

Filter photometer

86.

Which of the following is an oxidizing agent?

a)

Ascorbic acid

b)

KMnO4

c)

Sodium thiosulfate

d)

Sodium nitrite

87.

A method used to assay Vitamin B12 and Ca pantothenate is by:

a)

Iodimetry

b)

Micro-bio/ turbidimetric

c)

Fluorometry

d)

Iodometry

88.

The assay of aldehyde content in volatile oil may be by:

a)

Gravimetric

b)

Bisulfite

c)

Hydroxylamine

d)

B and C

89.

One of the fundamental laws in spectroscopy is:

a)

Law of mass action

b)

Beer’s law

c)

Boyle’s law

d)

Newton’s law

90.

Gas chromatography is utilized in the separation of:

a)

Volatile component in a liquid mixture

b)

Amino acids

c)

Blood components

d)

A and B

91.

In column chromatography, the separation of the sample mixture into a series of narrow bands in a column is called:

a)

Chromatogram

b)

Eluent

c)

Development

d)

A and B

92.

In spectrometry, when a test solution is prepared and observed identically with a reference standard, they are called:

a)

Isomeric substance

b)

Similar solutions

c)

Similar preparations

d)

B and C

93.

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

94.

A one percent (1%) solid in liquid solution is officially (USP) understood as:

a)

1 g in 100 mL

b)

100 mg in 1 mL

c)

10 g in 1000 mL

d)

10 g in 1 L

95.

When packaging and storage requirements specify a “well close 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

96.

When packaging and storage requirements specify 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

97.

When packaging and storage requirements specify a “hermetic 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 quality of water recommended in the preparation of compedial dosage forms is:

a)

Deionized water

b)

Distilled water

c)

Purified water

d)

Water for injection

99.

The quality of water recommended in the preparation of parenteral solutions is:

a)

Sterile purified water

b)

Purified water

c)

Water for injection

d)

Sterile water for injection

100.

Metallic impurities detected in the USP Heavy Metal test are:

a)

Lead and mercury

b)

Copper and tin

c)

Both a and b

d)

None of the above

101.

Treated soda lime glass is classified as:

a)

Type I

b)

Type II

c)

Type III

d)

NP

102.

A Soda Lime glass becomes a Treated Soda Lime glass through:

a)

Dealkilation

b)

Oxidation

c)

Hydrolysis

d)

None of the above

103.

The water attack test determines the chemical resistance to water of what type of glass?

a)

Type I

b)

Type II

c)

Type III

d)

NP

104.

The type of glass most suitable for parenteral preparation is:

a)

Type I

b)

Type II

c)

Type III

d)

NP

105.

An amber glass bottle for an oral syrup preparation is considered light resistant if it allows not more than what percent of light to be transmitted?

a)

10% at any wavelength in range from 290 to 450 nm

b)

15% at any wavelength in range from 290 to 450 nm

c)

20% at any wavelength in range from 290 to 450 nm

d)

25% at any wavelength in range from 290 to 450 nm

106.

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

a)

Biological Reactivity Test, In Vitro

b)

Biological Reactivity Test, In Vivo

c)

Both a and b

d)

None of the above

107.

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

a)

Biological Reactivity Test, In Vitro

b)

Biological Reactivity Test, In Vivo

c)

Both a and b

d)

None of the above

108.

Plastic materials which comply with the requirements of Biological Reactivity Test, In Vitro are essentially:

a)

Non cytotoxic

b)

Non carcinogenic

c)

Both a and b

d)

None of the above

109.

The conductivity of water is expressed in what unit?

a)

µS/cm

b)

µS/cm²

c)

µmho²/cm

d)

None of the above

110.

The acceptable pH level of water used for pharmaceutical compounding is:

a)

Between 6.0 and 7.0

b)

Between 5.0 and 7.0

c)

Between 7.0 and 8.0

d)

None of the above

111.

In the manufacture of sterile parenteral solutions all added raw materials must be sterile.

a)

Necessary

b)

Not necessary

c)

Always

d)

None of the above

112.

A large volume intravenous solution has a minimum volume of:

a)

1000 mL

b)

200 mL

c)

500 mL

d)

None of the above

113.

A small volume of intravenous solution has a maximum volume of:

a)

1000 mL

b)

200 mL

c)

500 mL

d)

None of the above

114.

A sterile parenteral solution is also non pyrogenic:

a)

All the time

b)

Most of the time

c)

Sometime

d)

Not at all

115.

If the bacterial endotoxin limit of a dosage form is 0.25 EU/mL it means all components of the preparation should contribute:

a)

≤ 0.25 EU/mL

b)

≥ 0.25 EU/mL

c)

< 0.25 EU/mL

d)

None of the above

116.

Finished product sterilization by autoclaving will destroy pyrogens in the preparation:

a)

All the time

b)

Most of the time

c)

Sometime

d)

Not at all

117.

Sterility Testing of Pharmacopoeial articles tests for the presence of:

a)

Gram (+) and gram (-) organism

b)

Aerobic and anaerobic organism

c)

Both a and b

d)

None of the above

118.

Long term stability testing of pharmaceutical articles is carried out at:

a)

23 ± 2°C, 60 ± 5% RH

b)

25 ± 2°C, 60 ± 5% RH

c)

20 ± 2°C, 60 ± 5% RH

d)

None of the above