Exam 1 - Phintern 2
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The following are agents used in tablet and capsule formulations to improve flow properties of the powder mix, EXCEPT:
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Lactose
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Talc
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Cornstarch
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Colloidal silica
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EXAM 1 - PHINTERN 2 focuses on evaluating knowledge in pharmaceutical tablet and capsule formulation. It assesses understanding of excipients, processing issues, and quality control tests, crucial for professionals in pharmaceutical technology.
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- 2.
What is the classification of Yellow Ointment USP as base?
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Hydrocarbon
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Oleaginous
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Absorption
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A and B
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A and C
Correct Answer
A. A and BExplanation
Yellow ointment USP is classified as an oleaginous / hydrocarbon base. The two terms are synonymous.Rate this question:
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- 3.
Which of the following is a tablet processing problem characterized by adhesion of tablet particles onto the punch?
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Flaking
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Sticking
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Picking
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Mottling
Correct Answer
A. StickingExplanation
Tablet sticking is the phenomenon of tablet particles adhering to the tablet punch. This is a costly processing problem as it results in a smaller batch yield due to loss of product.Rate this question:
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- 4.
Which of the following QC tests for tablets may be used to assess the strength of a binder excipient in the formulation? I. Friability II. Hardness III. Drug content IV. Disintegration time
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I and II
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III and IV
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I, II, and III
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I, II, and IV
Correct Answer
A. I and IIExplanation
Friability testing assesses the ability of the tablet to withstand mechanical stress and abrasion, which indirectly evaluates the strength of the binder. Hardness testing directly measures the tablet's resistance to crushing or breaking, which is affected by the strength of the binder. Therefore, both friability and hardness tests are relevant for assessing the strength of a binder excipient in tablet formulation.Rate this question:
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- 5.
Which of the following excipients can be added to a tablet formulation to prevent sticking of powder particles on the surface of processing equipment?
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Gelatin
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Magnesium stearate
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Sodium starch glycolate
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Talc
Correct Answer
A. Magnesium stearateExplanation
Magnesium stearate is a lubricant, which prevents sticking of powder particles on processing equipment. Gelatin acts as a binder. Talc is a glidant. Sodium starch glycolate is a disintegrant.Rate this question:
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- 6.
Which of the following preparations would likely have the shortest shelf life?
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Aqueous solution, 2% drug
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Tincture, 60% ethanol
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Syrup, 85% sugar
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Chlorpheniramine elixir, 15% ethanol
Correct Answer
A. Aqueous solution, 2% drugExplanation
The ethanol content in tinctures & elixirs and the high concentration of sugar in syrup prevent microbial growth. Aqueous solutions are most susceptible to microbial growth, thus shortening shelf life.Rate this question:
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- 7.
Regarding emulsions, which of the following statements is/are true?I. Emulsions are thermodynamically stable systems.II. Oil is the continuous phase in O/W emulsions.III. Emulsifying agents promote stability in emulsions.
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I only
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I and II
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II and III
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III only
Correct Answer
A. III onlyExplanation
I. Emulsions are thermodynamically unstable systems, and oil is the dispersed phase in O/W emulsions.Rate this question:
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- 8.
A surfactant with an HLB value of 7-11 is used primarily as a __________.
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W/O emulsifier
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O/W emulsifier
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Detergent
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Anti-foaming agent
Correct Answer
A. W/O emulsifier -
- 9.
Which of the following statements about liniments is false?
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Oily liniments are preferred for massages.
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Liniments were formerly called embrocations.
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Alcohol-based liniments are milder than oily liniments.
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Liniments should not be applied to broken skin.
Correct Answer
A. Alcohol-based liniments are milder than oily liniments.Explanation
Oily liniments are milder than alcohol-based liniments.Rate this question:
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- 10.
Regarding the preparation of ointments and creams by fusion, which of the following is false?
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Solids may be levigated with a portion of the base before adding to melted components.
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Heat-labile and volatile substances are added first immediately after fusion.
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During cooling, the rest of the components are added until congealed.
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Ingredients with the highest melting points are melted at the lowest required temperature.
Correct Answer
A. Heat-labile and volatile substances are added first immediately after fusion.Explanation
Heat-labile and volatile substances are added later, after the preparation has cooled, to avoid thermolysis or evaporation of substances.Rate this question:
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- 11.
The most commonly used fixed oils in injections are the following, EXCEPT:
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Cottonseed oil
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Peanut oil
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Coconut oil
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Sesame oil
Correct Answer
A. Coconut oilExplanation
Most commonly used fixed oils for injections: Mnemonic, CoCoPeSe
1. Cottonseed oil
2. Corn oil
3. Peanut oil
4. Sesame oilRate this question:
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- 12.
What is the percentage of castor oil content in flexible collodion?
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1%
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2%
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3%
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5%
Correct Answer
A. 3%Explanation
The correct answer is 3% because flexible collodion typically contains 3% castor oil. Castor oil is commonly used in flexible collodion to provide a protective and moisturizing effect on the skin.Rate this question:
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- 13.
In which of the following non-Newtonian systems does viscosity increase with the application of shear stress?I. DilatantII. PseudoplasticIII. Shear-thinningIV. Shear-thickening
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I and III
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I and IV
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II and III
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II and IV
Correct Answer
A. I and IVExplanation
A dilatant or shear-thickening substance is a Non-Newtonian fluid where the shear viscosity increases with applied shear stress.Rate this question:
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- 14.
The following information must appear on the primary display panel of medicinal preparations, EXCEPT:
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Pharmacologic category
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Name of manufacturer
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"For External Use Only"
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Formulation
Correct Answer
A. FormulationExplanation
The primary display panel of medicinal preparations should include important information such as the pharmacologic category, name of the manufacturer, and whether it is for external use only. However, the formulation of the preparation does not need to be mentioned on the primary display panel. The formulation refers to the specific ingredients and composition of the medication, which is typically provided in the package insert or on the product label itself, but not on the primary display panel.Rate this question:
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- 15.
Over the span of two months, a distributor delivers four consecutive shipments of substandard raw materials to your manufacturing plant. In order to uphold the quality of your products, you decide to apply a more rigorous inspection level for their materials. What inspection level do you assign them?
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General Inspection Level I
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General Inspection Level II
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General Inspection Level III
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Special Inspection Level S1
Correct Answer
A. General Inspection Level IIIExplanation
General Inspection Level I - Less stringent inspection level for trusted companies which consistently deliver quality materials
General Inspection Level II - Default inspection level
General Inspection Level III - Rigorous inspection level for companies which have delivered substandard materialsRate this question:
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- 16.
Which of the following statements about labeling of medicinal preparations is false?
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The area of the principal display panel shall be 40% the total surface of the container.
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The brand name shall have the highest point size, written in the same font as the generic.
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Rx symbol must be printed in contrasting color as the background.
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Storage conditions shall appear outside the principal panel of the label.
Correct Answer
A. The brand name shall have the highest point size, written in the same font as the generic.Explanation
Generic name should have the highest point size, written in the same font as the brand name.Rate this question:
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- 17.
In which of the following methods for emulsion preparation is the emulsifier mixed first with the oil, and then water is added all at once?
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Continental method
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English method
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Wet Gum method
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Both B and C
Correct Answer
A. Both B and CExplanation
Dry gum / continental method: Oil, gum, water
Wet gum / English method: Gum, oil, waterRate this question:
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- 18.
Which of the following statements about mannitol are false?
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It is a common excipient for hypodermic tablets.
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It has a cooling effect which masks bitter tastes.
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It is a polyol and an isomer of sorbitol.
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It is used as a sweetener for patients with diabetes.
Correct Answer
A. It is a common excipient for hypodermic tablets.Explanation
Mannitol is a common excipient for chewable tablets.Rate this question:
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- 19.
Which of the following is not an ideal property for tablet fillers?
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Hygroscopic
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Relatively cheap
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Inert
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Compatible with the formulation
Correct Answer
A. HygroscopicExplanation
Hygroscopicity refers to the ability of a substance to absorb moisture from the surrounding environment. In the context of tablet fillers, a hygroscopic filler would absorb moisture from the formulation, leading to changes in the tablet's physical properties and potentially affecting its stability. Therefore, being hygroscopic is not an ideal property for tablet fillers as it can compromise the quality and performance of the tablets.Rate this question:
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- 20.
Which of the following excipients are matched incorrectly with their specific use?
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Avicel: Diluent
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Binder: Acacia gum
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Disintegrant: Magnesium stearate
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Glidant: Talc
Correct Answer
A. Disintegrant: Magnesium stearateExplanation
Magnesium stearate is an antiadherent / lubricant.Rate this question:
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- 21.
Which of the following sterilization methods is best used in the production of Activase®, a recombinant enzyme drug?
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Dry heat sterilization
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Filtration sterilization
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Moisture heat sterilization
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UV light sterilization
Correct Answer
A. Filtration sterilizationExplanation
Any type of heat sterilization may not be used for enzyme drugs, which are thermolabile. UV light sterilization is toxic, so the best choice is filtration sterilization, which is used for heat sensitive parenterals and biological products.Rate this question:
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- 22.
Which of the following tablet production problems describes a defect where color distribution is not uniform throughout the tablet?
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Double impression
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Mottling
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Lamination
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Cracking
Correct Answer
A. MottlingExplanation
Mottling is a tablet production problem that refers to a defect where the color distribution is not uniform throughout the tablet. This means that there are variations in color intensity or patches of different colors on the surface of the tablet. This defect can occur due to issues with the mixing or distribution of the colorants during the tablet manufacturing process.Rate this question:
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- 23.
Which of the following tablet processing problems involves the adhesion of a tablet surface to the face of the punch?
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Erosion
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Capping
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Sticking
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Picking
Correct Answer
A. PickingExplanation
Sticking - adhesion of tablet particles to the die wall
Picking - adhesion of tablet particles to the punchRate this question:
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- 24.
What tablet processing problem appears as the separation of the tablet into several distinct horizontal layers?
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Lamination
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Capping
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Cracking
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Chipping
Correct Answer
A. LaminationExplanation
Lamination is the tablet processing problem that appears as the separation of the tablet into several distinct horizontal layers. This occurs when the tablet formulation does not bind properly, causing the layers to separate.Rate this question:
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- 25.
Solid particles aggregate in deflocculated suspensions. Deflocculated suspensions are less likely to cake than flocculated suspensions.
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Only the first statement is true.
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Only the second statement is true.
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Both statements are true.
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Both statements are false.
Correct Answer
A. Both statements are false.Explanation
Flocculated suspensions contain aggregated solid particles, which allow for easier suspension after settling. This reduces its likely of caking.Rate this question:
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- 26.
Which of the following excipients increase the likelihood of settling in suspensions?
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Thickening agent
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Suspending agent
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Flocculating agent
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Wetting agents
Correct Answer
A. Flocculating agentExplanation
Flocculating agents cause the solid particles to aggregate, which encourages settling of particles in suspension.Rate this question:
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- 27.
Which of the following statements about shelf life is true?I. Shelf life is synonymous with expiration date.II. A drug that has passed its shelf life might still be safe for consumption, but its quality is no longer guaranteed.III. A drug's shelf life is usually shortened if it is not stored in its original marketed container.
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I and II
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I and III
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II and III
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III only
Correct Answer
A. II and IIIExplanation
Shelf life is NOT synonymous with expiration date. When a drug has passed its shelf life, its quality is no longer guaranteed, however it may still be safe for consumption. Upon passing the expiration date, a drug is neither guaranteed quality nor safety. Original product packaging is designed to protect the drug against external factors which may affect its shelf life.Rate this question:
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- 28.
Which of the following choices increase the risk of contamination in the manufacturing process?I. Curved corners in production roomsII. Multi-directional movement of personnel between roomsIII. Proper sanitation, hygiene, and apparel of personnel
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I and II
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II and III
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I only
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II only
Correct Answer
A. II onlyExplanation
Multi-directional movement between rooms increases the risk of cross-contamination and mix-ups.Rate this question:
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- 29.
- The ISO is an international body which gives a company license to conduct manufacturing activities.
- An ISO certification ensures that a manufacturing process has all the requirements for standardization and quality assurance.
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Only the first statement is true.
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Only the second statement is true.
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Both statements are true.
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Both statements are false.
Correct Answer
A. Only the second statement is true.Explanation
The FDA is a governing body which issues licenses to conduct manufacturing activities. The ISO merely certifies quality assurance and processes in a manufacturing company.Rate this question:
- 30.
Class 100 environment can be defined as:
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Total particles do not exceed 100 per cubic foot of air of 0.5 µm at normal condition.
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Total particles do not exceed 100 per cubic meter of air of 0.5 µm at rest.
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Total particles do not exceed 100 per cubic meter of air of 0.5 µm at normal condition.
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Total particles do not exceed 100 per cubic meter of air of 0.5 µm at rest.
Correct Answer
A. Total particles do not exceed 100 per cubic foot of air of 0.5 µm at normal condition.Explanation
< 100 per cubic foot of air of 0.5 µm at normal condition.
When a room is at rest (i.e. no movement, production, personnel, etc.), there is definitively lesser amount of particles in circulation in the air. It would not accurately reflect contamination in a working environment.Rate this question:
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- 31.
What are intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use?
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Powders
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Granules
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Binders
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A and B
Correct Answer
A. PowdersExplanation
Powders are intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. Powders are commonly used in pharmaceuticals, cosmetics, and other industries for their ease of administration and versatility. They can be dissolved in liquids, applied topically, or taken orally. Powders are preferred for their ability to be accurately measured and their rapid dissolution or dispersion in the body. They can be formulated to have specific properties such as controlled release or improved bioavailability. Overall, powders are a widely used form of medication or substance delivery.Rate this question:
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- 32.
Which of the following is the correct order of tablet sugarcoating?
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Sealing, smoothing, subcoating, color coating, polishing
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Subcoating, sealing, smoothing, color coating, polishing
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Smoothing, sealing, subcoating, color coating, polishing
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Sealing, subcoating, smoothing, color coating, polishing
Correct Answer
A. Sealing, subcoating, smoothing, color coating, polishingExplanation
The correct order of tablet sugarcoating is sealing, subcoating, smoothing, color coating, and polishing. The process begins with sealing the tablet to prevent moisture and other substances from entering. Then, a subcoating is applied to create a smooth surface for the color coating. After that, the tablet is smoothed to remove any imperfections. Next, a color coating is added to give the tablet its desired appearance. Finally, the tablet is polished to enhance its shine and overall aesthetic appeal.Rate this question:
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- 33.
This is the critical operation in the sugarcoating process of tablets that can have a marked effect on ultimate tablet quality.
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Sealing
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Smoothing
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Subcoating
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Color coating
Correct Answer
A. SubcoatingExplanation
Subcoating is the correct answer because it is the critical operation in the sugarcoating process of tablets that can have a marked effect on ultimate tablet quality. Subcoating involves applying a thin layer of coating material to the tablet surface before the sugarcoating process. This subcoating layer helps to improve tablet durability, prevent moisture penetration, and enhance the adhesion of the sugarcoating layer. Therefore, subcoating plays a crucial role in ensuring the overall quality and effectiveness of the sugarcoated tablets.Rate this question:
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- 34.
Which of the following is the specific use of titanium dioxide in tablet coating?
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Plasticizer
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Glossant
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Opaquant
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Surfactant
Correct Answer
A. OpaquantExplanation
Titanium dioxide is used as an opaquant in tablet coating. Opaquants are substances that provide opacity or whiteness to the coating, making it more visually appealing and masking the color of the tablet's core. Titanium dioxide is commonly used in pharmaceutical tablet coatings to achieve a solid, opaque, and uniform appearance. It helps to ensure that the tablet's color and any imperfections in the core are not visible, enhancing the overall aesthetic appeal of the tablet.Rate this question:
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- 35.
Mesh number refers to:
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Number of linear openings per square inch
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Number of circular openings per square inch
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Number of square openings per linear inch
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Number of circular openings per linear inch
Correct Answer
A. Number of square openings per linear inchExplanation
Mesh number refers to the number of square openings per linear inch. This means that the correct answer is "Number of square openings per linear inch." This measurement is commonly used in industries such as manufacturing, construction, and filtration to determine the size and density of a mesh or screen. It helps to classify the mesh based on the number of openings it has per linear inch, allowing for precise filtering or separation of materials.Rate this question:
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- 36.
Which of the following increases tablet disintegration time?
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Decrease in binder content
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Increase in lubricant content
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Decrease in tablet compression force
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None of the above
Correct Answer
A. Increase in lubricant contentExplanation
Lubricants increase disintegration time by decreasing wettability of tablets due to its hydrophobicity.Rate this question:
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- 37.
Which of the following solid dosage forms does not need to conform to USP disintegration time?
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Chewable tablets
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Film-coated tablets
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Enteric-coated tablets
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Sugar-coated tablets
Correct Answer
A. Chewable tabletsExplanation
Chewable tablets do not need to conform to USP disintegration time because they are designed to be chewed and dissolved in the mouth before swallowing. The disintegration time is not relevant for these tablets as they are intended to be broken down and absorbed in the oral cavity rather than in the stomach or intestines like other solid dosage forms.Rate this question:
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- 38.
These are alcoholic or hydroalcoholic solutions prepared from vegetable materials or chemical substances.
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Elixir
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Spirits
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Tinctures
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Fluid extracts
Correct Answer
A. TincturesExplanation
Tinctures are alcoholic or hydroalcoholic solutions prepared from vegetable materials or chemical substances. This means that they are made by dissolving these substances in alcohol or a mixture of alcohol and water. Tinctures are commonly used in herbal medicine and homeopathy as a way to extract and preserve the active compounds from plants or other substances. They are often taken orally and are known for their concentrated and potent effects.Rate this question:
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- 39.
Sweetening agent which is 200 times sweeter than sucrose, has no aftertaste, and provides approximately 4 kcal per 1 g.
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Aspartame
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Cyclamate
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Saccharin
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Sucralose
Correct Answer
A. AspartameExplanation
Aspartame is the correct answer because it is a sweetening agent that is 200 times sweeter than sucrose (table sugar), has no aftertaste, and provides approximately 4 kcal per 1 g. Saccharin and cyclamate are also artificial sweeteners, but they do not meet all the given criteria. Sucralose is another artificial sweetener, but it is not 200 times sweeter than sucrose. Therefore, aspartame is the best fit for the given description.Rate this question:
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- 40.
Which of the following are false about Syrup USP?
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It can be used as a vehicle or sweetening agent.
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It requires the addition of a preservative.
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It is an 85% sugar solution.
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It is also known as Simple Syrup.
Correct Answer
A. It requires the addition of a preservative.Explanation
Simple Syrup USP is fully self-preserving.Rate this question:
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- 41.
This method produces finely divided particles by spraying a mist of liquid through a heated chamber, drying immediately, and collecting the dried powders in a clean receptacle.
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Micronization
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Spray-drying
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Freeze-drying
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Homogenization
Correct Answer
A. Spray-dryingExplanation
Spray-drying is the correct answer because it involves the process of producing finely divided particles by spraying a mist of liquid through a heated chamber. The liquid quickly dries in the hot air, leaving behind dried powders that are collected in a clean receptacle. This method is commonly used in various industries to create powdered products such as food ingredients, pharmaceuticals, and chemicals.Rate this question:
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- 42.
A parenteral route of administration in which an aqueous solution is preferred for optimum absorption. It produces instantaneous pharmacological effect, since it bypasses absorption.
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Intraspinal
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Intramuscular
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Intravenous
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Subcutaneous
Correct Answer
A. IntravenousExplanation
Intravenous administration is the correct answer because it involves injecting a solution directly into the veins. This route allows for immediate absorption of the medication into the bloodstream, bypassing the need for absorption through the gastrointestinal tract or other tissues. Intravenous administration is preferred when an instantaneous pharmacological effect is desired, as it allows for rapid and efficient delivery of the medication to the target site.Rate this question:
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- 43.
Which of the following are potential sources of pyrogens in the manufacture of parenterals?I. Contaminated water and solutesII. Contaminated equipmentIII. Manufacturing methods
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I and II
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II and III
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I and III
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I, II, and III
Correct Answer
A. I, II, and IIIExplanation
Pyrogens are substances that can cause fever when introduced into the body. In the manufacture of parenterals (products that are injected into the body), potential sources of pyrogens can include contaminated water and solutes, contaminated equipment, and even the manufacturing methods themselves. All three options (I, II, and III) are potential sources of pyrogens and can contribute to the presence of these fever-inducing substances in parenteral products.Rate this question:
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- 44.
Which of the following is an in-vitro method of pyrogen testing based on color development with lysate from amoebecytes of the horseshoe crab?
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Qualitative fever response in rabbits
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Qualitative fever response in mice
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Limulus method
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All of the above
Correct Answer
A. Limulus methodExplanation
The correct answer is the Limulus method. This method is an in-vitro method of pyrogen testing that uses lysate from amoebocytes of the horseshoe crab. The lysate reacts with pyrogens, causing a color development that can be measured. The other options, qualitative fever response in rabbits and qualitative fever response in mice, are not in-vitro methods and do not involve the use of horseshoe crab lysate.Rate this question:
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- 45.
At which temperature range are most biological products stored?
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2 - 8 °F
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2 - 8 °C
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8 - 15 °F
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8 - 15 °C
Correct Answer
A. 2 - 8 °CExplanation
Most biological products are stored at temperatures between 2 - 8 °C. This temperature range is commonly used for storing vaccines, blood products, and other sensitive biological materials. It helps to maintain the stability and integrity of these products, preventing spoilage or degradation. The range of 2 - 8 °C is considered ideal for preserving the potency and efficacy of biological products, ensuring that they remain safe and effective for use.Rate this question:
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- 46.
This phenomenon is the taking up of liquid by a gel without measurable increase in volume.
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Swelling
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Imbibition
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Syneresis
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Xerogel
Correct Answer
A. ImbibitionExplanation
Imbibition refers to the process in which a gel absorbs liquid without any significant change in its volume. This phenomenon occurs due to the capillary action, where the liquid is drawn into the gel's network of pores or spaces between its particles. As a result, the gel swells and takes up the liquid, but the overall volume remains relatively unchanged. This process is commonly observed in various natural and synthetic gels, such as hydrogels, where they can absorb large amounts of water without expanding significantly.Rate this question:
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- 47.
Which of the following parts of a tablet press distributes the granulation material into the die cavity?
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Feed shoe
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Hopper
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Upper and lower punches
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Auger
Correct Answer
A. Feed shoeExplanation
The feed shoe is the part of a tablet press that distributes the granulation material into the die cavity. It is responsible for delivering a consistent and uniform amount of material into the die cavity during the compression process. The feed shoe helps ensure that each tablet is formed with the correct amount of granulation material, resulting in consistent tablet weight and quality.Rate this question:
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- 48.
A tablet formulation contains two (2) APIs which are chemically incompatible with one another. Which of the following is the best method to use for tablet formation?
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Dry granulation
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Wet granulation
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Slugging
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Multiple-layered compression
Correct Answer
A. Multiple-layered compressionExplanation
Multiple-layered compression is the best method to use for tablet formation when the tablet formulation contains two APIs that are chemically incompatible with each other. This method involves compressing multiple layers of different materials, allowing for the physical separation of the incompatible APIs. This prevents direct contact between the APIs, reducing the chances of chemical reactions or degradation. Dry granulation, wet granulation, and slugging methods may not provide the same level of physical separation and may lead to chemical interactions between the APIs.Rate this question:
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- 49.
Which of the following are necessary components of effervescent tablets?I. Sodium carbonateII. Tartaric acidIII. Citric acid
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I only
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I and II
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II and III
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I, II, and III
Correct Answer
A. II and IIIExplanation
Necessary components are:
I. Sodium bicarbonate
II. Tartaric acid
III. Citric acidRate this question:
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