Quality Control 1 and 2 (PACOP Green) Flashcards
A buret with a glass stopcock can be used for:
a. Alcohols
b. Bases
c. Acids
d. Salts
c. Acids
The operation speed for paddle in a dissolution apparatus is:
a. 150 rpm
b. 200 rpm
c. 100 rpm
d. 50 rpm
d. 50 rpm
Radiant energy refers to:
a. Visible
b. IR
c. UV
d. All of the above
d. All of the above
High pressure liquid chromatography method of analysis is more advantageous than the other column chromatography as to:
a. Ease to operate
b. Greater speed
c. More precise
d. All of the above
d. All of the above
Content uniformity test is to be performed for all tablet products whose active ingredient is:
a. 50 mg or smaller
b. 324 mg or more
c. 130-324 mg
d. 130 mg or less
a. 50 mg or smaller
The statement of expiration date assures the patient:
a. Absence of toxicity
b. Full therapeutic efficacy
c. Complete absorption of drug
d. Absence of interaction
b. Full therapeutic efficacy
A factor obtained by taking the ratio of the actual normality to the theoretical normality is:
a. Titer
b. Normality factor
c. Flame photometer
d. Polarimeter
b. Normality factor
To measure the optical activity of a sample, the instrument used is:
a. Spectrometer
b. Refractometer
c. Flame photometer
d. Polarimeter
d. Polarimeter
- In phenol content determination of a volatile oil, the layer in the graduated neck of the cassia flask read 2.7 mL obtained from a sample of 10 mL of the oil after treatment of KOH. The % phenol is:
a. 69.8
b. 27.0
c. 73.0
d. 7.30
c. 73.0
- Using the Karl Fischer method, determine the moisture content of a sample of raw material where a 63 mg sample consumed 0.75 mL of titrant. Water equivalence factor is 1.10
a. 1.8%
b. 1.3%
c. 2.10%
d. 0.74%
B. 1.3%
During shipment of the finished product to the wholesale or retail outlets, the responsible person should ensure:
a. Product identification
b. No damage, spillage, or breakage
c. Segregation of different types
d. All of the above
d. All of the above
To find the mEq factor of an oxidizing agent is to divide the molecular weight by:
a. Valence
b. No. of electron lost
c. No. of electrons gained (VDGEROA)
d. Replaceable hydrogen
c. No. of electrons gained (VDGEROA)
Lower control limit if mean is 10.5 mL and one standard deviation is 0.025
a. 10.450 mL
b. 10.420 mL
c. 10.575 mL
d. 10.425 mL
d. 10.425 mL
Gas chromatography is utilized in the separation and identification of:
a. Amino acid
b. Alkaloids
c. Volatile liquids in a mixture
d. Blood components
c. Volatile liquids in a mixture
The name of the originator of using silver nitrate as the titrant and potassium chromate as the indicator in volumetric precipitation of chloride
a. Volhard
b. Beer
c. Mohr
d. Fajan
c. Mohr
Reassay date of thiamine HCl if tested in December 1992
a. 6/93
b. 12/93
c. 12/94
d. 6/94
b. 12/93
Find the acid number of a raw material a mole weighing 1.230 g which required 30 mL of 0.1100 N NaOH to bring out the end point using alcoholic KOH in the titration
a. 150.54 mg/g
b. 157.72 mg/g
c. 109.18 mg/g
d. 124.41 mg/g
a. 150.54 mg/g
A critical defect that would stop the packaging operation is:
a. Misaligned label
b. Wrong label
c. Smeared label
d. Inverted label
b. Wrong label
An instrument used to measure the durability of tables to shipping/transportation against shock and abrasion
a. Metal detector
b. Top loading balance
c. Friabilator
d. Colorimeter
c. Friabilator
Methods of microbial assay of antibiotics
a. Turbidimetric
b. Cylinder plate
c. Both A and B
d. None of the above
a. Turbidimetric
Retention or preservation of samples and records of all pharmaceutical products should be monitored for signs of deterioration. The length of time they should be stored is:
a. 2 years after date of expiration
b. 1 year after date of expiration
c. 2 years
d. 3 years
b. 1 year after date of expiration
Potentiometry finds application in:
a. Biological assay
b. Identification test
c. Qualitative analysis
d. pH determination
d. pH determination
In the assay of sulfonamides, the method used is
a. Diazotization
b. Acid-base titration
c. Gravimetric
d. Volumetric
a. Diazotization
A term in compleximetry used to indicate a determination of a metal in the presence of another metal
a. Linking
b. Masking
c. Complexing
d. Redox
b. Masking
cGMP is:
a. An agency created by RA 3720
b. Also known as food, drug, and cosmetic act
c. Both A and B are correct
d. Both A and B are incorrect
d. Both A and B are incorrect
The sampling and examination of all raw materials received by the factory is a function of the:
a. Documentation
b. Biological testing laboratory
c. Material inspection
d. Analytical laboratory
d. Analytical laboratory
The indicator for EDTA direct titration against CaCO3 is:
a. Methyl red
b. Hydroxynaphthol blue
c. Methylene blue
D. Thymol blue
b. Hydroxynaphthol blue
Safety or toxicity for infusion plastic sets is conducted using:
a. Dogs
b. Food ingestion
c. White mice
d. Rabbits
c. White mice
Chemical analysis which determines the amount of percentage content in which the component of a substance is present:
a. Quantitative
b. Proximate
c. Qualitative
d. Ultimate
a. Quantitative
The addition of overage is justified when:
a. The clinical studies show that the overage is safe therapeutically
b. The unstable active ingredients cannot be possibly standardized
c. Both statements are correct
d. Both statements are incorrect
c. Both statements are correct
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 the labeled potency
a. 99%
b. 93%
c. 90%
d. 95%
c. 90%
Adsorbents used in TLC:
a. Silica gel and aluminum dioxide
b. Aluminum oxide
c. Silica gel
d. Kieselguhr
a. Silica gel and aluminum oxide
Content uniformity test is conducted in:
a. 5 tablets
b. 20 tablets
c. 10 tablets
d. 15 tablets
c. 10 tablets
The most effective manner to clean glass apparatus is:
a. Soaking in detergent
b. Treatment with chromic acid
c. Rinsing with alcohol
d. Rinsing with nitric acid
B. Treatment with chromic acid
Ferrous sulfate is:
a. Agent that loses electron
b. An oxidizing agent
c. Reducing agent
d. Both A and C
c. Reducing agent
A test which is determined by selecting not less than 30 tablets from each production batch and assaying 10 tablets individually as directed in the assay of the individual compedial monograph
a. Content uniformity
b. Weight variation
c. Disintegration test
d. Dissolution test
a. Content uniformity
These are instruments under spectrometric methods which operate based on the absorption or emission of electromagnetic radiation as a result of its interaction with matter, EXCEPT:
a. Potentiometer
b. NMR
c. X-ray
d. IR
a. Potentiometer
The ash content of an organic compound is an impurity of:
a. Inorganic matter
b. Carbon
c. Gas
d. Volatile oil
a. Inorganic matter
Type of QC equipment used for measuring the absorbance of substances between regions 380-780 nm
a. UV/VIS spectrophotometer
b. Infrared spectrophotometer
c. Mass spectrophotometer
d. Colorimeter
a. UV/Vis spectrophotometer
Type of titration used in volumetric analysis:
a. Neutralization
b. Residual
c. Direct
d. Both B and C
a. Neutralization
The choice method of determining the alcohol content of pharmaceutical preparation:
a. Specific gravity
b. Percolation
c. Fractional distillation
d. Cryoscopic
a. Specific gravity
The gram molecular weight of sulfuric acid is 98. A solution containing 49 g/L of solution is:
a. 0.2 M
b. 0.5 N
c. 1 N
d. 1 M
c. 1 N
USP steroid identification test:
a. Gravimetric
b. Spectrophotometric
c. Fluoroscopic
d. Chromatographic
b. Spectrophotometric
Which of the following are principles of chromatographic separation?
I. Adsorption
II. Partition
III. Ion-exchange
IV. Molecular exclusion
a. I and II
b. I, II, and III
c. I, II, III, and IV
d. None of the above
c. I, II, III, and IV
Titer is an expression of concentration in terms of:
a. g/L
b. mg/L
c. g of solute/100 mL
d. g or mg/mL
b. mg/L
Titrating an alkaline sample with an acid standard solution is known as:
a. Direct alkalimetry
b. Gravimetric analysis
c. Precipitation method
d. Indirect alkalimetric
a. Direct alkalimetry
Retention or preservation of samples and records of all pharmaceutical products should be monitored for sign of deterioration. The length of time they should be stored is:
a. 2 years
b. 1 year after the expiry date of the product
c. 3 years
d. 2 years after the expiry date
b. 1 year after the expiry date of the product
LAL reagent is used to:
a. Measure pH of solution
b. Test the presence of pyrogens
c. Prevent the oxidation of parenteral prep
d. Acts as preservative for pharmaceutical
b. Test the presence of pyrogens
Control chart limit which alerts the operator to closely monitor the process:
a. Warning limit
b. Action limit
c. Acceptable limit
d. Any of these
c. Acceptable limit
In process inspection tests to be performed during the filling of parenteral products
a. Viscosity
b. Light inspection for clarity of solution
c. Fill volume
d. Light inspection and fill volume
d. Light inspection and fill volume
USP limit for tablet content uniformity
a. 90-110%
b. 90-100%
c. 95-110%
d. 85-115%
d. 85-115%
Analysis function would include:
a. Shelf-life studies
b. In-process control
c. Raw material control
d. All of these
d. All of these
In the SQC, the control chart prepared based on the number of fraction defective is called:
a. Attribute chart
b. Bar chart
c. Beer’s plot
d. Variable chart
a. Attribute chart
The number of linear openings per square inch is known as:
a. Sieve
b. Mesh
c. Both A and B
d. None of these
b. Mesh
Test used to determine the strength of tablets include:
a. Content uniformity
b. Hardness
c. Weight variation
d. Both A and B
b. Hardness
Which of the given is the least used as sampled materials?
a. Final product
b. Records
c. Immediate product
d. Raw materials
b. Records
The presence of cotton fiber in a liquid preparation is considered a/an:
a. Critical defect
b. Variable defect
c. Internal defect
d. Ocular defect
d. Ocular defect
A special residual method in acidimetry intended for the determination of nitrogen content in organic compounds
a. Karl Fischer method
b. Back titration
c. Volhard method
d. Kjeldahl method
d. Kjeldahl methodAs
Assay of 250 mL solution of dopamine 200 mg injection resulted in the following data. Based on these, determine the amount of dopamine in 100 mL solution:
Sample volume - 5.0 mL
Solution volume - 250.0 mL
Absorbance sample - 38259
Absorbance standard - 20163
a. 0.04 mg/100 mL
b. 4.5 mg/100 mL
c. 3.8 mg/100 mL
d. 4.5 mg/100 mL
a. 0.04 mg/100 mL
The disintegration constant of a radioisotope is 0.0502 day. Calculate the half life of the radioisotope.
a. 11 days
b. 13 days
c. 15 days
d. 21 days
b. 13 days
Determine the distance traveled by the solute, if its Rf value is 0.688 and the solvent travels 8.0 cm. The sample weight is 1.02 mg.
a. 11.6 cm
b. 11.8 cm
c. 5.5 cm
d. 0.70 cm
c. 5.5 cm
One mole of dichromate ions gains a total of _____ electrons when converted to chromous ion
a. 3
b. 6
c. 10
d. None of the above
b. 6
Koetsdorfer number is a synonym for:
a. Ester value
b. Saponification value
c. Iodine value
d. Acetate value
b. Saponification value
The chemical constant used in the analysis of fats and oils are:
a. Iodine value
b. Saponification value
c. Acid value
d. All of the above
d. All of the above
Water content of raw materials is determined by quality control equipment, such as:
I. Ohaus moisture balance
II. Karl Fischer titrimetry
III. pH meter
IV. Vacuum oven
a. I, II and IV
b. II, III, and IV
c. I, II, and III
d. I, II, III, and IV
a. I, II, and IV
The primary standard used to standardize Karl Fischer reagent is:
a. Anhydrous sodium carbonate
b. Potassium biphthalate
c. Sodium tartrate
d. Sodium oxalate
c. Sodium tartrate
Plastic containers for ophthalmic or parenteral preparations are sterilized by:
a. Microwave
b. Autoclaving
c. Soaking in formalin
d. Ethylene oxide
d. Ethylene oxide
A sample is:
a. Is taken from a population
b. It should represent the whole batch from where it is taken
c. Is a finite number of objects selected from a population
d. All of the above
d. All of the above
Instrument to determine the tightness of a cap is:
a. Crimper
b. Torque tester
c. Resister
d. pH meter
b. Torque tester
Its primary objective is to monitor all features of a product
a. SOP
b. Sampling
c. Stability testing
d. IPQC
d. IPQC
It has a high degree of purity and is used in direct standardization purposes:
a. Technical grade
b. CP grade
c. Primary standard
d. Any of the above
d. Any of the above
The primary standard used for standardization of Ce(SO4)2 in cerimetric method of analysis is:
a. K2Cr2O7
b. As2O3
c. KMnO4
d. H2C2
b. As2O3
In paper partition chromatography, what is the Rf value of a compound if the solute travels 3.1 cm and the solvent moves 4.3 cm after 5 minutes?
a. 3.605
b. 0.721
c. 13.33
d. 1.387
b. 0.721
A sampling inspection in which decision is made to accept or to not accept an item:
a. Rejection number
b. Acceptance sampling
c. Acceptance number
d. Any of the above
b. Acceptance sampling
Indicators used for acid-base titration, EXCEPT:
a. Methyl red
b. Methyl orange
c. Phenolphthalein
d. Ferric alum
d. Ferric alum
Sample sizes of bottles to check for cap tightness
a. 10
b. 30
c. 20
d. 15
a. 10
Quantitative analysis of morphine
a. Ultimate analysis
b. Proximate assay
c. Ultimate assay
d. Proximate analysis
c. Ultimate assay
What is the normality of sulfuric acid containing 73.5 g/500 mL of solution?
a. 2.0 N
b. 2.5 N
c. 3.0 N
d. 1.0 N
c. 3.0 N
Three months of acceptable data at 37-40°C/75% RH can be extrapolated to _____ year/s expiry date
a. 1
b. 5
c. 4
d. 2
d. 2
The periodic examination on the quality of inventories is a function of:
a. Quality coordination office
b. Biological testing lab
c. Analytical lab
d. Material inspection section
d. Material inspection section
The spotting agent for amino acids in paper chromatography is:
a. Potassium chromate
b. Ninhydrin
c. Silver nitrate
d. Iodine
b. Ninhydrin
Negligible ash in a pharmaceutical preparation is:
a. 200 mg
b. 1000 mg
c. 500 mg
d. 500 mcg
d. 500 mcg
The reassay date of raw material is based on their:
a. Stability
b. Price
c. Quantity purchased
d. None of the above
a. Stability
Quality must be built into the product during:
a. Research
b. Development
c. Production
d. All of the above
d. All of the above
Recommended indicator in the assay of alkaloids:
a. Phenolphthalein
b. Methyl red
c. Methyl orange
d. Litmus paper
b. Methyl red
The titrant in no-aqueous alkalimetry is:
a. Ammonium hydroxide
b. Perchloric acid
c. Sodium methoxide
d. Sodium hydroxide
c. Sodium methoxide
Two substances reacting upon reaching the endpoint must have the same:
a. Number of equivalents
b. Volume
c. Normality
d. Weight
a. Number of equivalents
In radiopharmacy, REM means
a. Roentgen equivalent man
b. Radiation per millisecond
c. Radiation per minute
d. Roentgen exposure per minute
a. Roentgen equivalent man
One of the laws in spectrophotometry:
a. Law of mass action
b. Boyle’s law
c. Newton’s law
d. Beer’s law
d. Beer’s law
Substances that have the power of rotating the plane polarized light are said to be:
a. Light sensitive
b. Optically active
c. Active constituents
d. Dextrorotatory
b. Optically active
Nephelometry is based on the measurement of light that is:
a. Reflected
b. Transmitted
c. Absorbed
d. Adsorbed
a. Reflected
The process of determining the volume of standard solution required to react with a known amount of substance being assayed
a. Neutralization
b. Titration
c. Oxidation
d. Hydrolysis
b. Titration
Color of phenolphthalein in caustic potash
a. Pink
b. Yellow
c. Colorless
d. Orange
a. Pink
The potency of a drug component is commonly determined by:
a. HPLC
b. Titrimetric method
c. GC
d. Spectrophotometric method
a. HPLC
The index of refraction of a volatile oil is determined by using:
a. Spectrophotometer
b. Pycnometer
c. Refractometer
d. Polarimeter
c. Refractometer
A type of sampling which is permitted if the first one fails:
a. Double
b. Single
c. Both A and B
d. None of the above
a. Double
What is preferred for the standardization of permanganate?
a. Sodium oxalate
b. Sodium carbonate
c. Hydrogen peroxide
d. Sodium nitrate
a. Sodium oxalate
Instability will be accelerated by:
a. Temperature
b. Heat
c. Light
d. All of the above
d. All of the above
Assay of NaCl in table salt by precipitation as AgCl, filtration, drying, and weighing the reside is classified as:
a. Precipitimetry
b. Volhard method
c. Gravimetric analysis
d. Residual precipitimetry
c. Gravimetric analysis
An analyst who determines the strength, potency, and percentage purity of a drug or pharmaceutical product is performing:
a. Pharmaceutical assaying
b. Identification test
c. Pharmacopoeial test
d. Special test
a. Pharmaceutical assaying
Type of alkaloidal assay where the total alkaloids are determined
a. Ultimate
b. Specific
c. Extraction
d. Proximate
d. Proximate
The measurement of a base of a given sample by titration with a standard acid is known as:
a. Acidimetry
b. Compleximetry
c. Alkalimetry
d. Redox
a. Acidimetry
Which of the following substance is assayed by residual alkalimetric analysis?
a. Aspirin
b. Sodium hydroxide
c. Hydrochloric acid
d. Zinc oxide
a. Aspirin
The molecular weight of NaOH is 40. How many grams of NaOH pellets are needed to make 500 mL of 1.5 N solution?
a. 20
b. 30
c. 40
d. 60
b. 30
Which of the following is the most effective chemical substance in removing stains of potassium permanganate?
a. Oxalic acid
b. Sodium thiosulfate
c. Chalk
d. Vinegar
a. Oxalic acid
Which of the following indicators is the least used for acid-base titration?
a. Methyl orange
b. Phenolphthalein
c. Ferric alum
d. Methyl red
c. Ferric alum
Residual method titration with EDTA is applicable to what metal ion?
a. Calcium
b. Aluminum
c. Zinc
d. Magnesiu,
b. Aluminum
Chemical reactions that involve a change in the valence number of reacting substances
a. Neutralization
b. Complexation
c. Oxidation-reduction
d. Precipitation
c. Oxidation-reduction
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
c. Iodometry
Malic acid represent in cherry juice may be determined by:
a. Indirect permanganate oxidation method
b. Direct permanganate oxidation method
c. Alkalimetry
d. Acidimetry
a. Indirect permanganate oxidation method
Iodometry is an indirect analysis of:
a. Oxidizing agents
b. Reducing agents
c. Acids
d. Bases
a. Oxidizing agents
The chemical factor used in calculation of percent purity of a substance in volumetric analysis
a. mEq weight
b. Molarity
c. Molality
d. None of the above
a. mEq weight
Adsorption indicators are used in:
a. Compleximetry
b. Acidimetry
c. Volumetric precipitation
d. Alkalimetry
c. Volumetric precipitation
The indicator used in permanganate titration
a. Methyl orange
b. Phenolphthalein
c. Permanganate solution
d. Methyl red
c. Permanganate solution
The indicator for EDTA direct titration of calcium carbonate:
a. Thymol blue
b. Hydroxynaphthol blue
c. Methyl red
d. Methylene blue
b. Hydroxynaphthol blue
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
a. No. of electrons gained
A term in compleximetry used to indicate a determination of a metal in the presence of another metal
a. Redox
b. Masking
c. Linking
d. Complexing
b. Masking
Two substances reacting upon reaching the endpoint must have the same:
a. Normality
b. Volume
c. No. of equivalents
d. Weight
c. No. of equivalents
The method of assay for sulfonamides is:
a. Acid-base titration
b. Gravimetric
c. Diazotization with nitrite
d. Redox titration
c. Diazotization with nitrite
Which of the following is a reducing agent?
a. Ascorbic acid
b. Potassium permanganate
c. Iodine
d. Hydrochloric acid
a. Ascorbic acid