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WorksheetsPINK QA & QC-2
Total questions: 118
Worksheet time: 59mins
1 N HCl VS can be standardized using:
Sodium bicarbonate
Potassium phthalate
Sodium oxalate
Tromethamine
Method II of determining iodine value is also known as:
Hub’s method
Wij’s method
Hanus method
All of the choices
Residual titration method is also known as:
Direct titration
Indirect titration
Back titration
Redox titration
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
The standard substance used in checking the cleanliness of Abbe refractometer by determining its refractive index is:
Rose oil
Water
Methanol
Peanut oil
Coulometric titration of water determination is also known as:
Method I c
Method II
Method I a
Method III
Perchloric acid in glacial acetic acid and perchloric acid in dioxane are volumetric solution used in what type of analysis?
Direct acidimetry
Direct alkalimetry
Non-aqueous acidimetry
Non-aqueous alkalimetry
The primary standard used in the standardization of the above VS is:
Sodium carbonate
Sodium bicarbonate
Potassium biphtalate
Benzoic acid
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.
I only
I and II only
I, II, and III
None of the choices
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.
59.4
69.4
79.4
89.4
Hydrolysis products of ASA are:
Acetic acid + sodium hydroxide
Acetic acid + salicylic acid
Salicylic acid + sodium hydroxide
Sodium salicylate + water
The measurement of a base of a given sample by titration of standard acid is:
Acidimetry
Alkalimetry
Compleximetry
Redox titration
A characteristic of a substance which is suitable for non-aqueous titrimetry is:
Weakly reactive
Weakly basic
Very soluble in water
a and b
b and c
To remove stain of KMnO4, the most effective chemical substance is:
Oxalic acid
Sodium thiosulfate
Vinegar
Bromine solution
The oxidation number of Mn in KMnO4 is:
+2
+1
+5
+7
Which of the following chemicals is not included in preparing the Karl Fischer reagent?
Pyridine
Acetone
Sulfur dioxide
Iodine
The process in which the exact concentration of solution is determined.
Neutralization
Standardization
Titration
Complexation
Titer is an expression of concentration of solution is determined.
g of solute/100 mL
g or mg/mL
g of solute/L
b and c
Methyl orange in base medium is colored:
Yellow
Pink
Colorless
Green
Assay of zinc oxide is what type of analysis?
Alkalimetric residual
Acidimetric direct
Acidimetric residual
Alkalimetric direct
The indicator used if weak acid is titrated with strong alkali is:
Methyl orange
Methyl red
Phenol red
Phenolphthalein
Phenolphthalein in alkali medium is colored:
Yellow
Pink
Colorless
Blue
Suppository that does not melt at body temperature is what kind of defect?
Major
Critical
Minor
Performance
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
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.
Gravimetric analysis
Acidimetric analysis
Direct alkalimetric analysis
Residual titration
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:
Acid value
Ester value
Hydroxyl value
Saponification value
The instrument used to measure the optical activity of the sample is:
Refractometer
Polarimeter
Spectrometer
Flame photometer
Analysis in which separation of the constituents from the sample is done and then weighing the product is:
Volumetric analysis
Instrumental method of analysis
Gravimetric analysis
Special method of analysis
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
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.
I only
I and II only
I, II, and III
All of the statements are incorrect
Which of the following area is not a responsibility of quality control manager?
Specification and analytical development
Biological testing lab
Analytical lab
Market research
Hexane is the best solvent extracting:
Resins
Fats
Volatile oil
Acid
What is the other name of Koettsdorfer number?
Acid value
Saponification value
Ester value
Iodine value
The unsaponifiable matter present in animal fats is:
Cholesterol
Phytosterol
Lard
Wax
The crude fiber of a drug usually consist of:
Cellulose
Cholesterol
Phytosterol
All of the choices
The unsaponifiable matter present in vegetable oils and fats is:
Cholesterol
Cellulose
phytosterol
lard
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.
83.7%
93.7%
103.7%
113.7%
Which of the following volumetric solutions is used in diazotization analysis of sulfa drugs?
0.1 M sodium nitrite
0.05 edetate disodium
0.01 M sodium nitrite
0.1 N Iodine solution
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
0.09196
0.91960
0.21090
0.01209
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.
99%
95%
94%
93%
Which of the following standard solutions is not used in redox titration?
Sodium thiosulfate solution
Iodine solution
Bromine solution
Sodium hydroxide solution
Assay of ASA (raw material) is an example of what method of analysis?
Direct alkalimetry
Residual alkalimetry
Direct acidimetry
Residual acidimetry
Assay of sodium nitrite is an example of what method of analysis?
Direct titration – Redox
Indirect titration – Redox
Residual titration – Redox
Iodimetry
An analyst who determines the strength, potency and percentage purity of a drug or pharmaceutical product is performing:
Special method
Identification test
Pharmacopoeial testing
Pharmaceutical assaying
Two substances reacting upon reaching the end point must have the same:
Normality
Volume
Number of mEq
Weight
Most of the official drugs containing Calcium and Magnesium are determine by:
Gravimetric
Complexometry
Bioassay
Non-aqueous matter
Type of titration used in volumetric analysis:
Direct
Residual
Indirect
All of the above
The iodine value of an oil is a quantitative measure of:
Phenol coefficient
Saturated fatty acid
Unsaturated fatty acid
Unsaponifiable matter
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:
90.44
90.23
89.0
90.54
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:
1.20
1.21
12.10
1.10
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).
283.7 mg
141.86 mg
0.2836 g
A and C
The primary staining reagent of the Gram procedure is:
Methyl red
Carbol fuchsin
Crystal violet
Saffranin
The bacterial structure responsible for selective permeability is:
Cell wall
Fimbriae
Spore
Cytoplasmic membrane
The measurement of a base of a given sample by titration with the standard acid is:
Acidimetry
Alkalimetry
Complexometry
Redox
Analysis where separation of the constituent from the sample is done that weighing the products is:
Volumetric
Gravimetric
Special
Gasometric method
Adsorption indicators are used in:
Complexometric reaction
Acidimetry
Volumetric precipitation
Alkalimetry
Titer is an expression of concentration in terms of:
g of solute per 100 mL
g or mg of solute per mL
g per liter
A and C
Iodimetry is what type of titration?
Direct
Indirect
Residual
A and C
The type of alkaloidal assay where the total alkaloids are determines is:
Ultimate
Specific
Proximate
Precision
To measure optical activity of a sample, the instrument used is:
Polarimeter
Refractometer
Spectrometer
Flame photometer
The indicator for EDTA titration against CaCO3 is:
Thymol blue
Hydroxynaphthol blue
Methyl red
Methylene blue
In neutralization methods in aqueous medium, a product is:
Oil
Salt
Precipitate
A and B
The moisture content of a drug maybe:
Water of hydration
Water in the adsorbed form
Water of crystallization
All of the above
The oxidation number of atomic iodine is:
+1
+2
+4
+3
A spectrophotometer differs from a colorimeter is that it consists of:
Prism
Lamp house
Cell compartment
B and C
The ash content of an organic compound is an impurity of:
Prism
Lamp house
Oil
Volatile oil
To keep samples moisture-free the apparatus used is:
Desiccator
Furnace
Incubator
Oven
Microbial assay of an antibiotics maybe performed using the following except:
Test tube inoculation
Cylinder plate method
Paper disk method
Titration process
Result of the experiment that are close to one another is considered to be:
Accurate
Cylinder plate method
Approximate
A and C
Flame Spectroscopy procedures maybe divided into:
Flame emission
Atomic adsorption
Nuclear magnetic resonance
A and B
Safety and Toxicity test are conducted using:
Rabbits
Dogs
White mice
Guinea pig
A parenteral is declared pyrogenic if the temperature rise in rabbits is:
Less than 1.4°C in the 9 readings of the 3 rabbits
0.6°C in the 1 of the 9 readings
>1.4°C in the 9 readings of the 3 rabbits
None of the above
The ester value determination of substance is applicable to the following except:
Fats
Volatile oil
Alcohols
Fatty oils
In Gas chromatography, the results of the assay is expressed in:
Retention on the column
Rf value
Volume of the gas used
Adsorbent
The process by which the exact concentration of a solution is determined by:
Neutralization
Standardization
Hydration
Titration
The infrared region of the spectrometer used to identify a substance uses a wavelength range of:
3-5 μm
380-780 μm
200-380 μm
15-300 μm
The primary standard used to standardize Karl Fischer reagent is:
Sodium carbonate anhydrous
Potassium biphthalate
sodium tartrate dihydrate
sodium bicarbonate
The molecular weight of sulfuric acid is 98. Its equivalent weight is:
98
49
0.098
0.049
The type of ash where sulfuric acid used to whiten the ash is:
acid insoluble ash
sulfated ash
The oil from peppermint can be determined by using:
Cassia flask
Bobcock bottle
Pycometer
Titration
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?
20
30
40
60
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:
15.5 mcg
17.55 mcg
17.40 mcg
15.9 mcg
Nephelometry is based on the measurement of light that is ______ by the particles of a suspension.
Reflected
Absorbed
Transmitted
Absorbed
The type of chromatography where the cellulose of the filter paper is used as the adsorbent is:
Column
Paper
TLC
Gas
All of the following are optical devices except:
pH meter
Spectrophotometer
Colorimeter
Filter photometer
Which of the following is an oxidizing agent?
Ascorbic acid
KMnO4
Sodium thiosulfate
Sodium nitrite
A method used to assay Vitamin B12 and Ca pantothenate is by:
Iodimetry
Micro-bio/ turbidimetric
Fluorometry
Iodometry
The assay of aldehyde content in volatile oil may be by:
Gravimetric
Bisulfite
Hydroxylamine
B and C
One of the fundamental laws in spectroscopy is:
Law of mass action
Beer’s law
Boyle’s law
Newton’s law
Gas chromatography is utilized in the separation of:
Volatile component in a liquid mixture
Amino acids
Blood components
A and B
In column chromatography, the separation of the sample mixture into a series of narrow bands in a column is called:
Chromatogram
Eluent
Development
A and B
In spectrometry, when a test solution is prepared and observed identically with a reference standard, they are called:
Isomeric substance
Similar solutions
Similar preparations
B and C
Beer’s plot in spectrometry is prepared to determine:
Absorbance of the sample
Wavelength to be used
Blank
Concentration of the drug substance
A one percent (1%) solid in liquid solution is officially (USP) understood as:
1 g in 100 mL
100 mg in 1 mL
10 g in 1000 mL
10 g in 1 L
When packaging and storage requirements specify a “well close 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
When packaging and storage requirements specify 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
When packaging and storage requirements specify a “hermetic 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 quality of water recommended in the preparation of compedial dosage forms is:
Deionized water
Distilled water
Purified water
Water for injection
The quality of water recommended in the preparation of parenteral solutions is:
Sterile purified water
Purified water
Water for injection
Sterile water for injection
Metallic impurities detected in the USP Heavy Metal test are:
Lead and mercury
Copper and tin
Both a and b
None of the above
Treated soda lime glass is classified as:
Type I
Type II
Type III
NP
A Soda Lime glass becomes a Treated Soda Lime glass through:
Dealkilation
Oxidation
Hydrolysis
None of the above
The water attack test determines the chemical resistance to water of what type of glass?
Type I
Type II
Type III
NP
The type of glass most suitable for parenteral preparation is:
Type I
Type II
Type III
NP
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?
10% at any wavelength in range from 290 to 450 nm
15% at any wavelength in range from 290 to 450 nm
20% at any wavelength in range from 290 to 450 nm
25% at any wavelength in range from 290 to 450 nm
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
Both a and b
None of the above
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
Both a and b
None of the above
Plastic materials which comply with the requirements of Biological Reactivity Test, In Vitro are essentially:
Non cytotoxic
Non carcinogenic
Both a and b
None of the above
The conductivity of water is expressed in what unit?
µS/cm
µS/cm²
µmho²/cm
None of the above
The acceptable pH level of water used for pharmaceutical compounding is:
Between 6.0 and 7.0
Between 5.0 and 7.0
Between 7.0 and 8.0
None of the above
In the manufacture of sterile parenteral solutions all added raw materials must be sterile.
Necessary
Not necessary
Always
None of the above
A large volume intravenous solution has a minimum volume of:
1000 mL
200 mL
500 mL
None of the above
A small volume of intravenous solution has a maximum volume of:
1000 mL
200 mL
500 mL
None of the above
A sterile parenteral solution is also non pyrogenic:
All the time
Most of the time
Sometime
Not at all
If the bacterial endotoxin limit of a dosage form is 0.25 EU/mL it means all components of the preparation should contribute:
≤ 0.25 EU/mL
≥ 0.25 EU/mL
< 0.25 EU/mL
None of the above
Finished product sterilization by autoclaving will destroy pyrogens in the preparation:
All the time
Most of the time
Sometime
Not at all
Sterility Testing of Pharmacopoeial articles tests for the presence of:
Gram (+) and gram (-) organism
Aerobic and anaerobic organism
Both a and b
None of the above
Long term stability testing of pharmaceutical articles is carried out at:
23 ± 2°C, 60 ± 5% RH
25 ± 2°C, 60 ± 5% RH
20 ± 2°C, 60 ± 5% RH
None of the above
