1. Castor oil belongs to what type of laxative? 4.

The Research Department of a pharmaceutical

A. Bulk-forming laxatives manufacturing establishment is important in:
B. Saline laxatives A. Developing new products
C. Stimulant laxatives B. Improving existing new products
D. Emollient laxatives C. AOTA
D. NOTA
Types of Laxatives Mechanism of Examples
Action The following are the different tasks of the research
Bulk-forming Forms bulk by Polycarbophil, department
absorbing water psyllium  Develop new products
Saline Draws water into Sodium  Improve already existing products
intestinal tract by biphosphate  Do market research, pharmaceutical research,
osmosis chemical research (includes analysis, synthesis and
Stimulant Stimulates the Phenolphthlein, identification of products)
intestinal wall Castor oil  Physiologic research (effect on animals, toxicity or
Emollient Softens stool by Docusate sodium allergic reactions)
lubrication

5. The following are responsibilities of Production

2. Emulsions containing volatile oils may be prepared by: Department:
A. Continental method A. Receiving materials and supplies
B. Dry Gum Method B. Warehouse and storage
C. Bottle Method C. NOTA
D. Wet gum D. AOTA

The Bottle Method, also known as the Forbes The following are the tasks of the production
Method, is a variation of the dry gum method. It is used for department:
the extemporaneous preparation of emulsions from volatile  Receiving materials and supplies
oils or oleaginous substances of low viscosities. In this  Warehousing and storage
method, the components are placed in a bottle and shaken.  Manufacture of products
 Packaging and production control
In the Continental or Dry Gum Method, the
emulsifying agent is mixed with the oil before the addition of
water. It is also referred to as the 4:2:1 method. Remember: 6. The Quality Department often called the heart and life of
EA + O + W = emulsion the company is in charge of:
A. Ensuring uniform production of high quality
In the English or Wet Gum method, the emulsifying B. Safeguarding public health
agent is added to water to form a mucilage, and then the oil C. Ensuring that minimum standards of the products comply
is slowly incorporated to form the emulsion. Remember: with the FDA requirements
W + EA = mucilage + oil = emulsion D. AOTA

The quality control department is in charge of the

3. This is used to solidify glycerine suppositories following:
A. AOTA  Assurance of uniform quality products
B. Glycerol triacetate  Ensure public safety
C. Stearic acid  Dose sampling, assaying, and systematic recording
D. Sodium stearate and compiling
 Ensure minimum standards of the product comply
Glycerin suppositories are composed of glycerine, with FDA
sodium stearate and water and are generally used a
cathartic. Sodium stearate is used as the solidifying agent
while glycerine is the hydrophilic base.
7. The Medical Department of a pharmaceutical
manufacturing establishment is in charge of:
A. Clinical studies
B. Preparation of new package inserts
C. AOTA
D. NOTA
The medical department does the following:
 Physical and medical examination of employees
 Medical treatment of employees
 Conduct clinical studies
 Preparation of literature and inserts
 Publish house organ
 Take charge of scholarships
8. Irregular agglomerates of small particles which behave as
single layer particles are known as:
A. Bulk powders
B. Granules
C. Lines
D. NOTA
Generally, granules are prepared by moistening the
desired powder mixture and passing the moistened mass
through a screen mesh size that will produce the desired size
granules. Some of the advantages of granules are as follows:
 Flow well compared to powders
 Generally more stable physically and chemically
than are the corresponding powders from which
they are prepared
 Less likely to cake or harden upon standing
 More easily wetted by a solvent
9. Powders and granulated products are often dispensed as:
A. Bulk powders and granules for internal use
B. Divided powders and granules for internal uses
C. Dusting powders for internal uses
D. Both A and B
Generally, dispensing of powdered drugs in bulk
amounts is limited to non-potent substances. The mixed
ingredients are packaged into a suitable bulk consider such
as a wide mouthed jar
Powders that should be administered in controlled
dosage or those containing potent substances are usually
divided amounts individual doses are separately packed.
10. Dosage form used to administer medicated powders
blowing into air, nose or throat.
A. Oral powders
B. Aerosols
C. Insufflations
D. Any of the given
Insufflators are the simplest devices for oral or nasal
inhalation of dry solids. Disadvantages such as lack of
pharmaceutical elegance, less convenient in application than
other topical preparations and non-uniformity of dose
delivered (especially if the powder contained a drug which
had systemic effect) lead to decline of its use
11. Powders for compression must possess fluidity and:
A. Compressibility
B. Flowability
C. Adhesiveness
D. Solubility
Fluidity is important so that the material can be
transported through the hopper of a tableting machine. It is
also essential so that adequate filling of the die occurs in the
tableting machine to produce tablets of consistent weight.
Compressibility which is defined as the property of
forming a stable, intact compact mass when pressure is
applied, is also essential. It is known in nearly all cases that
granulation improves compressibility.
12. An ideal drug delivery system is:
A. Capable of controlled delivery rates
B. Not highly sensitive to physiological variable
C. Applicable to a wide variety of drugs
D. Any of the above
Drug delivery system refers to the technology
utilized to present the drug to the desired body site for drug
release and absorption. The first drugs delivery was the
syringe, invented in 1865, used to deliver medication by
injection.
The following are attributes of an ideal drug delivery
system:
 Capable of controlled delivery rates to
accommodate the pharmacokinetics of various
drugs (flexible programming)
 Capable of precise control of a constant delivery rate
(precise programming)
 Not highly sensitive to physiological variables such
as gastric motility and emptying pH, fluid volume
and content of gut disease state
 The system is predicated on physicochemical
properties
 The system is capable of a high order of drug
dispersion
 Drug stability is maintained or enhanced
 The controlling mechanism adds little mass to the
dosage form
 Applicable to a wide range and variety of drugs
13. A sustained drug release system can be achieved through redispersed upon the gentle shaking of the
this formulation method container
A. Use of coating  The characteristics of the suspension should be such
B. Embedding the drug in a matrix that the particle size of the suspensoid remains fairly
C. Microencapsulation constant throughout the long periods of
D. All of the above undisturbed standing
 The suspension should pour readily and evenly from
Formulation methods used to obtain the desired the container
drug availability rate from the sustained action dosage forms
include:
 Increasing the particle size of the drug and/or 16. The term used for the coalescence of oil globules in an oil-
dosage form in-water emulsion
 Embedding the drug in a matrix A. Creaming
 Coating the drug or a dosage form containing the B. Cracking
drug C. Phase inversion
 Chemically reacting the drug with materials such as D. Flocculation
an ion exchange resin
Another name for cracking is breaking or
coalescence. The coalescence of oil globules in an o/w
14. For liquids which are _____________, a gravity-operated emulsion is resisted by the presence of a mechanically strong
filling set-up is used absorbed layer of emulsifier around each globule. This is
A. Free flowing achieved either by the presence of a condensed mixed
B. Foaming monolayer of lipophilic or hydrophilic emulgents or by a
C. Viscous multimolecular film of a hydrophilic material.
D. Either A or B Creaming is the separation of an emulsion into two
regions one of which is richer in the dispersed phase than the
Gravity filling which is used for free flowing liquids is other.
relatively slow. It is accomplished in this simple manner: the Flocculation involves the aggregation of the
liquid reservoir is positioned above the filling line with a hose dispersed globules into loose clusters within the emulsion.
connection from the reservoir to a shut off device at the
filling line. The shut off device is usually hand operated, and
the bottles are filled to graduations on the bottles 17. Test used to determine phase inversion in emulsion
Viscous liquids are filled using a pressure-operated A. Dye test
filling set-up. The pressure pump filter often is operated B. Torque
semi-automatically and differs from the gravity filter C. Incompatibility
principally in the liquid is under pressure. It is usually D. AOTA
equipped with an overflow tube connected to a receiver to
prevent excess filling of container. Phase inversion involves the conversion of an o/w
emulsion to a w/o or vice versa. The dye test can be used to
detect phase inversion through the use of water-soluble and
15. All of the following are attributes of a good suspension oil-soluble dyes, one of which will dissolve in and color the
except: continuous phase. Other methods to detect emulsion type
A. Must settle slowly are as follows:
B. Must be packed attractively
C. Must be easily redisperse upon shaking Test Results
D. NOTA Dilution Test Emulsion can be diluted only
with the external phase
The important characteristics of a pharmaceutical CoCl2/ filter paper Blue to pink when o/w
suspension are therapeutic efficacy, chemical stability of the emulsion is added
components of the preparation, permanency of the Fluorescence o/w dot pattern; w/o
formulation and aesthetic appeal. Other attributes of a good fluoresce through out
suspension are: Conductivity o/w – conducts electricity;
 A properly prepared pharmaceutical suspension w/o – no conduction
should settle slowly and should be readily
18. This process of drying involves sublimation of water from
a product after it is frozen
A. Lyophilization
B. Freeze drying
C. Tyndallization
D. A and B
Freeze-drying or lyophilisation essentially consists
of:
a. Freeze the aqueous product at a temperature below its
eutectic temperature
b. Evacuating the chamber usually below 0.1 torr (100um Hg)
c. Subliming ice on a cold condensing surface at a
temperature below that of the product, the condensing
surface within the chamber or in a connecting surface
d. introducing heat to the product under controlled
conditions, thereby providing energy for sublimation at a
rate designed to keep the product below its eutectic
temperature.
The advantages of lyophilization:
 Stabilization of heat and oxygen labile drugs
 Often more rapid solubility
 Greatly reduced levels of particulate matter
 Elegant appearance
19. Importance of a package includes:
A. For convenience
B. For legal compliance
C. For protection
D. AOTA
The following are the characteristics of a package:
 Economical and therefore contribute to overall
profitability
 Provide protection against climatic, biological,
physical and chemical hazards
 Provide and acceptable presentation which will
contribute whilst at the same time maintaining
adequate identification and information
 It must contribute in terms of convenience and
compliance
 Protection is almost invariably the most critical
factor since it controls the total shelf-life of the
product
20. Type of container which is impervious to air or any other
gas under ordinary or customary conditions
A. Well-closed
B. Tight
C. Hermetic
D. Light-resistant
A hermetic container is impervious to air or any
other gas under the ordinary or customary conditions of
handling, shipment, storage and distribution
A well-closed container protects the contents from
extraneous solids and from loss of the article under the
ordinary or customary conditions of handling, shipment,
storage and distribution
A tight container protects the contents from
contamination by extraneous solids, liquids or vapour, from
loss of the article and from efflorescence, deliquescence or
customary condition of handling, shipment, storage and
distribution and is capable of tight reclosure
A light-resistant container protects the contents
from the effects of light by virtue of the specific properties of
the material of which it is composed including any coating
applied to it
21. Highly resistant borosilicate glass is also known as:
A. Type I
B. Type II
C. Type III
D. NP
In type I or borosilicate glass, the alkaline element in
ordinary soda lime glass is largely eliminated by the use of
boric oxide to neutralize the oxides of potassium. Type I glass
is less brittle and has low thermal expansion and can be used
with safety over a wide temperature range.
The other types of glass are
 Type II glass is treated soda lime glass
 Type III glass is soda lime glass
 NP stands for non-parenterals
22. This medium is used for the disintegration plain uncoated
tablets
A. Simulated Gastric Fluid, TS
B. Simulated Intestinal Fluid, TS
C. Distilled Water
D. Potable Water
The disintegration medium for plain uncoated tables
is Distilled Water. Uncoated USP Tablets have disintegration
time standards as low as 5 minutes, but the majority of the
tablets have a maximum disintegration time of 30 minutes.
To be in compliance with the USP standards, the tablets
must disintegrate and all particles must pass through the
10mesh screen in the time specified. If any residue remains, it
must have a soft mass with to palpably firm core.
Simulated Gastric Fluid and Simulated Intestinal
Fluid are both used for the disintegration of enteric coated
tablets. Enteric coated tablets should not disintegrate in
Simulated Gastric Fluid in 2 hours but should disintegrate in
Simulated Intestinal Fluid in 1 hour
23. Component of closure that is inserted in a cap to effect a
hermetic seal between the closure and the container:
A. Cap
B. Liner
C. Liner seal
D. Stopper
The liner is a multilayered structure of resilient
packaging made of pulp (board), foil or plastic and it is used
to produce a hermetic seal between the closure and the
container.
The cap material may be plastic or foil
The inner seal can be wax paper, foil or plastic line
glued on or heat seated to provide tamper evidence
The coil absorbs force, shock to prevent damage
during shipment. It is usually made of cotton
of manufacture until its chemical or biological activity is not
less than 90% of labelled potency and its physical
characteristic have not changed appreciably deleteriously.
Overage is added to a pharmaceutical formulation
to keep the content of the active ingredient within the limits
compatible with therapeutic requirements for a
predetermined period of time. It is limited to a maximum of
30% over the labelled potency of an ingredient.
26. This test makes use of the lysate of horseshoe crab and is
used to test for the presence of pyrogens
A. Pyrogen test
B. LAL test
C. A and B
D. NOTA

Limulus Amebocyte Lysate is obtained from

24. The following are examples of tamper-resistant aqueous extracts of the circulating amebocytes of the
packaging, except: horseshoe crab, Limulus polyphemus, and which have been
A. Film wrappers prepared and characterized for uses a an LAL reagent. The
B. Blister reaction is characterized by the formation of a firm gel that
C. Strip remains when inverted through 180 degrees. A negative
D. NOTA result is characterized by the absence of such a gel or by the
formation of a viscous gel that does not maintain its
A tamper resistance package is defined as one integrity. This test is more sensitive than the pyrogen test.
having an indicator or barrier to entry, if breached or missing In the USP Pyrogen Test, healthy, mature rabbits
can reasonably be expected to provide visible evidence to are used to determine the absence of presence of pyrogens
consumers that tampering has occurred. Below are the that can be tolerated by the rabbit.
examples:
 Film wrappers
 Bubble packs 27. This type of defect is not likely to reduce materially the
 Shrink seals/bands usability of the unit of product for its intended purpose
 Foil/ paper or plastic pouches A. Critical defect
 Breakable caps B. Major defect
 Sealed Tubes C. Minor defect
 Sealed cartons D. AOTA
 Blister/ strip packs
 Bottle seals A minor defect is a departure from established
 Tape seals standards having the little bearing on the effective use of an
 Aerosol containers operation or unit.
A critical defect is a defect that judgment and
experience indicate is likely to result to hazardous or unsafe
conditions for individuals using, maintaining or depending
25. It is defined as the capacity of a drug to remain within
upon the products or a defect that judgment and experience
specifications established to assure its identity, strength,
indicate is likely to prevent performance of the tactical
quality and purity.
function of the major end item.
A. Stability
A major defect is a defect other than critical that is
B. Shelf-life
likely to result in failure or to reduce materially the usability
C. Overage
of a product for its intended purpose.
D. AOTA

Stability has been defined as the ability of particular

formulation in a specific container to remain within its 28. USP sterilization techniques include the following except:
physical, chemical, therapeutic and toxicological A. NOTA
specifications. It has also been defined as the time from date B. Sterilization by ionizing radiation
C. Sterilization by filtration penetration to the film to ensure penetration of the drug.
D. NOTA Polyethylene glycol (PEG) is an example of an alloying
substance.
All of the methods in the choices are sterilization A film former is capable of producing smooth, thin,
techniques. The table below shows the different sterilization reproducible under conventional coating conditions and
techniques: applicable to a variety of tablet shapes. Cellulose acetate
phthalate is an example of a film former.
Technique Method A plasticizer produces flexibility and elasticity of the
Steam sterilization 121 degrees Celsius coating and thus provides durability. An example of a
Gas sterilization Material can’t withstand high plasticizer is castor oil.
temperature in steam and A surfactant is used to enhance the spreadability of
dry heat. Uses ethylene the film during application. Examples are Spans and Tweens.
oxide or propylene oxide
Dry heat sterilization Temperature in empty
chamber is 4-15 degrees 31. Rapid drying leads to this film coating problem
Celsius when the unit is A. Blistering
operating at 250 degrees B. Sweating
Celsius C. Flaking
Sterilization by filtration Sterilization of heat labile D. Blooming
solutions by physical
removal of the contained Blistering is caused by too rapid evaporation of the
microorganisms solvent from the core and the effect of high temperature on
Sterilization by ionizing Uses gamma radiation and the strength, elasticity and adhesion of the film. This usually
radiation electron beam radiation or happens when coated tablets require further drying in ovens.
mechanical acceleration of
electrons
32. Which of the following is not an adhesive?
A. Starch powder
29. Tyndallization is performed at: B. Sucrose syrup
A. 100°C for 30 minutes C. Liquid glucose
B. 100°C for 1 hour D. NOTA
C. A and B
D. NOTA The substances that act as adhesives to bind
powders together in the wet granulation are known as
Tyndallization is also known as binders. Starch is a good and popular binder and needs to be
intermittent/fractional/discontinuous steam distillation. This present in an amount equal to 2%. It is incorporated in water.
sterilization technique which uses steam intermittently and Other examples are:
performed at a temperature of 100°C for 30 minutes or at  Acacia mucilage (up to 20%)
30°C for 1 hour. In tyndallisation, a fluid medium is healed in  Gelatin (5-20%)
the steam environment at atmospheric pressure for 20-45  Glucose (up to 50%)
minutes for three successive days. Germination of surviving  Polyvinylpyrolidone (2-10%)
spores is presumed to occur at room temperature between  Starch mucilage (5-10%)
heatings. The more susceptible vegetative forms are killed  Sucrose (up to 70%)
when the medium is heated.

33. This disintegrant has a surfactant effect

30. This filmcoating material provides water permeability to A. Starch
film B. Sodium lauryl sulphate
A. Film former C. Methylcellulose
B. Plasticizer D. AOTA
C. Alloying substance
D. Surfactant The function of a disintegrant in a formulation is to
promote breakup of the tablets when places in an aqueous
The function of an alloying substance is to provide environment. The disintegration increases the surface area
water solubility or permeability to the film to ensure of the tablet fragments and promotes rapid release of the
drug. Methylcellulose is a synthetic substitute for natural
gums. It is used as a dispersing, thickening, emulsifying,
sizing and coating agent. It is also used therapeutically as a
bulk laxative in the treatment of chronic constipation
Examples:
 Cation exchange resins
 Cross linked PVP
 Modified starches
 Cellulose materials
34. The most common diluents used for chewable tablets.
A. Sorbitol
B. Mannitol
C. Lactose
D. Dextrose
Chewable tablets are intended to disintegrate
smoothly in the mouth at a moderate rate either with or
without actual chewing. Mannitol, a white crystalline
hexahydric alcohol is the diluents of choice for chewable
tablets. It is about 70% as sweet as sucrose with a cool taste
and mouth feel. It is also used as an excipient in the
preparation of chewable tablets containing moisture
sensitive drugs because it is non-hygroscopic.
vertically delivers water in drops each of which weighs
between 45-55mg. One mL of water approximately weighs
about 1 gram or 1000mg and the average weight of one drop
of water is 50mg, therefore, 1000mg + 50mg = 20 drops of
water.
37. Inspissation is a method of fractional sterilization
performed at the temperature
A. 60°C
B. 100°C
C. 121.o °C
D. NOTA
Inspissation (60°C) is a fractional method of
sterilization relatively effective in reducing the number of
vegetative forms of microorganisms, but and unreliable
against spores. The process of inspissations consists of
heating materials in water bath or inspissator
discontinuously for 4-7 days, once per day for 30-60 minutes
at less than 100°C (the highest nondegrading tolerable
temperature). It is generally used for the heat sensitive
pharmaceuticals to which a bacteriostatic agent is usually
added.

38. Petroleum jelly belongs to what class of ointment bases?

35. Defect characterized by small pinholes on the surface of A. Water soluble bases
poorly manufacture tablets. B. Hydrocarbon base
A. Mottling C. Absorption base
B. Picking D. Water removable base
C. Capping
D. Compacting Ointment bases are classified into four general
groups:hydrocarbon, absorption, water-soluble and water
Picking is the term used to describe small pinholes removable bases.
on the surface of a tablet usually caused by overwetting or
excessive film lackness. In this case, the tablets stick to each HYDROCARBON (OLEAGINOUS) BASES
other or to the coating pan and on drying, at the same point - Water free and used chiefly for their emollient
of contact, a piece of the film may remain adhered to the pan effect, act as occlusive dressings
or to another tablet, giving a poked appearance to the tablet  Petrolatum (Yellow Petrolatum, Petroleum
surface and resulting in a small area of the cone. Jelly)
 White Petrolatum
 Yellow Ointment
36. The USP medicine dropper when held vertically delivers  White Ointment
how many drops of water?  Paraffin
A. 15 drops of water  Mineral Oil
B. 18 drops of water
C. 25 drops of water ABSORPTION BASES
D. 20 drops of water  Hydrophilic Petrolatum
 Anhydrous Lanolin
The USP Medicine Dropper consists of a tube made  Lanolin
of glass or other suitable transparent material that generally  Cold Cream
is fitted with a compatible bulb and while varying in capacity
constricted at the delivery and to be round opening having WATER REMOVABLE BASE
an external diameter of about 3mm. The dropper when held  Hydrophilic ointment
WATER SOLUBLE BASE
 Propylene glycol ointment
39. Used as a viscosity builder for ophthalmic preparations
except:
A. Polyethylene glycol
B. Polyvinyl alcohol
C. Polyvinyl pyrrolidone
D. Glycerol
In the preparation of ophthalmic solutions, a
suitable grade of methylcellulose or other thickening agent is
frequently added to increase the viscosity and thereby aid in
holding the drug in contact with the tissues so as to enhance
therapeutic effectiveness. Hydroxypropyl methylcellulose
and polyvinyl alcohol can also be used.
40. This suppository base does not melt at body temperature
A. Cocoa butter
B. Witepsol bases
C. Wecobee bases
D. Polyethylene glycol
Polyethylene glycol are polymers of ethylene oxide
and water, prepared to various chain lengths, molecular
weights and physical states. PEG suppositories do not melt
at body temperature but rather dissolve slowly in the body
fluids. Therefore the base need not be formulated to melt at
body temperature but mix with mucous secretions upon their
dissolution. PEG suppositories do not leak from the orifice as
do many cocoa butter-based suppositories.
41. Normal moisture content of hard gelatin capsules
A. 2-5%
B. 12-16%
C. 20-24%
D. 25-30%
Normally, hard gelatine capsules have a moisture
content of 13-16%. Gelatin is stable in air when dry but is
subject to microbial decomposition when it becomes moist
or when it is maintained in aqueous solution. If stored in an
environment of high humidity, additional moisture is
absorbed by the capsules and they may become distorted
and lose their rigid shape. An environment of extreme
dryness may cause some of the moisture normally present in
the gelatine capsules to be lost, and the capsules to become
brittle and to crumble when handled.
42. Function of colors and dyes in tablet formulations include
the following except
A. To disguise off-colored drugs
B. To disguise unpleasant tasting drugs
C. To provide product identification
D. To produce more elegant product
The use of coloring agents in pharmaceutical
preparations is important for purposes of aesthetics as
sensory adjuncts to the flavours employed and for purposes
of product distinctiveness. Coating of drugs usually disguises
the unpleasant taste of drugs
43. The containers used to package drugs may consist of
several components. This term best describes the release of
an ingredient from packaging components into the actual
product
A. Sorption
B. Leaching
C. Permeation
D. Porosity
Compounds leached from plastic containers are
generally polymer additives as the plasticizers, stabilizers or
antioxidants. Temperature, excessive agitation and the
stabilizing effect of the contents on one or more of the
polymer additives may influence leaching.
Sorption is the opposite of leaching. It is binding of
molecules to polymer materials.
Permeation is the process of solution and diffusion.
The material that penetrates initially dissolves in the plastic
material on one side and diffusing through the other side.
Porosity is characterized by minute holes or cracks
that are present and through which gas or moisture vapour
may move directly.
44. This small scale section of the manufacturing research
division serves as a testing ground for developing
manufacturing procedure for a commercial size of
pharmaceutical product
A. Research and development
B. Central Research
C. Production Facility
D. Pilot plant
The pilot plant’s primary function is to facilitate the
transfer of a product from the laboratory into production. Its
effectiveness is determined by the ease with which new
products or processes are brought into routine production.
45. Buffers for parenterals except
A. Citrates
B. Tartrates
C. Acetates
D. Lactates
To maintain product stability of many drugs, a
certain pH is required. Parenteral products should be
formulated to possess sufficient buffer capacity to maintain
proper product pH. Buffer systems for parenterals consist of
either a weak base or the salt of a weak base and a weak acid
and the salt of a weak acid. Buffers commonly used for
injectable products are acetates, citrates and phosphates.
46. One of the following is not a depyrogenation method
A. Filtration through asbestos
B. Heating at high temperature
C. Distillation
D. Autoclaving
Pyrogens which are products of the metabolism of
microorganisms produce a marked rise in temperature, chills,
body aches, cutaneous vasoconstriction and a rise in arterial
blood pressure. The temperature in an autoclave will not
destroy during a normal cycle.
Distillation frees water from pyrogens so that the
condensed molecules have gone through the vapour state
protected from inadvertent contamination and id the
distillate has been stored in a sterile condition.
Adequate cleaning and heating at temperature of
160°C for 3 to 4 hours or 269°C for 45 minutes may render
containers free from pyrogens. Recent studies have shown
that 650°C for 60 seconds will destroy the pyrogens.
Adsorption on the surface of selected adsorbants
can sometimes remove pyrogens from solutions.
47. Which of the following is not an advantage of the use of
parenterals?
A. Immediate physiologic action
B. Accuracy of dosage
C. Ease and convenience of administration
D. To slow the onset and prolong the duration of action
Advantages of parenterally administered drugs
include primarily the following:
 Rapid onset
 Predictable effect
 Predictable and nearly complete bioavailability
 Avoidance of the GIT, hence the problems of
variable absorption, drug inactivation and GI
distress
 Provides reliable drug administration in very ill or
comatose patients
48. The USP requirement for ophthalmic preparations is
A. Sterility
B. Isotonicity
C. Clarity
D. Non-pyrogenicity
The most important and most exacting step in the
formulation and manufacture of ophthalmic products is
sterility. The application of a variety of sterilization
procedures such as dry heat, steam under pressure, ethylene
oxide, filtration irradiation and sterilizing solutions is
required in the manufacture of ophthalmic preparations.
Sterilization is a major assurance of the quality of an
ophthalmic product. Lack of sterility could lead to the loss of
an eye.
49. This method of reducing granules is best suited for non-
volatile fatty materials
A. Slugging
B. Spray drying
C. Spheronization
D. Spray congealing
Spray congealing techniques are applicable to
waxes, alcohols, polymers and sugars which are solid at room
temperature but meltable at reasonable temperature.
Microencapsulation by spray congealing techniques can be
accomplished with spray drying equipment when the
protective coating is applied as melt. Coating solidification is
accomplished by spraying the hot mixture into air stream.
50. This method of compression is best suited for two or
more components which are chemically incompatible:
A. Wet granulation
B. Direct compression
C. Layered compression
D. Multiple layered compression
The advantages of layered compression are as
follows:
 Two incompatibilities drugs may be kept separate
by interposing a center, inert layer between them
 Each layer may have a separate color which can
serve as a means of identification
 Accurate control of the delayed or prolonged action
portion of the tablet is feasible
 Multilayer presses have greater hourly output than
the compression centers
51. This equipment provides the shortest drying time for wet
granulations
A. Drying oven
B. Incubator
C. Fluid bed dryer
D. Sun drying
The advantage of a fluid bed dryer is that efficient
heat and mass transfer give high drying rates so that drying
times are shorter than static bed convection driers. A batch
of tablet granules, for example, can be dried in 20-30 minutes
whereas a compartment drier would require several hours.
Apart from obvious economic advantages, the heating time
of thermostatic materials is minimized.
52. Mixing equipment for solid materials except
A. Sigma blade mixer
B. Ribbon blender
C. Twin shell V blender
D. AOTA
The sigma blade mixer deals with stiff pastes and
ointments and its action depends on the close intermeshing
of the two blades which resemble the Greek letter ∑ in shape.
Therefore, it is used mainly for the mixing of semisolids.
The ribbon blender consisting of a horizontal tank
usually opening at the top and fitted with helical blades that
are mounted on a shaft blades that are mounted on a shaft
through the long axis of the tank and are often both right and
left hand twist
The twin shell V blender having form of a cylinder
that has been cut in half at approximately a 45 degrees angle
with its long axis, and then rejoined to form a “V” shape is
rotated so that the material alternately is collected in the
bottom of the V and then split into two portions when the V
is inverted.
53. Tablet excipient used to make a reasonably sized tablet
A. Binders
B. Diluents
C. Disintegrants
D. Glidants
Diluents or bulking agents are substances that
usually make up the major portion of the tablet. The principal
substance used is Lactose, USP. Other example of diluents
include starches, mannitol, sorbitol and microcrystalline
cellulose.
Binders are substances that bind powders together
and make them cohesive. They are the adhesive in the
formulation. Examples are acacia, sucrose, starch paste,
gelatine solutions, PVP and hydroxypropylmethylcellulose.
Disintegrants are materials that help the tablet to
break up and dissolve to release the medicament. Examples
are starch derivatives, gums, alginates (sodium alginates and
alginic acid) and clays (bentonite and veegum)
Glidants are used in order for granules to flow from
a hopper on to the tablet press to the dies and for consistent
uniform fill and improve flow characteristics of the
granulations. Talc is an example of a glidant.
54. The pressure required to push the air through a liquid
saturated filter
A. Bubble point
B. Flash point
C. Saturation point
D. AOTA
The bubble point is the pressure required to push air
through a liquid saturated filter and is a function of the
porosity rating. Until this point is reached, the filter pores
retain liquid and unless there is rupture larger than the pore
diameter, air pressure will hold indefinitely. Filtration at
pressures lower than the bubble point of the membrane
prevents air from passing through the filter at the end of the
filtration cycle and excessive foaming is therefore avoided. It
is also a useful criterion for testing membrane efficiency.
Flash point is a test for the flammability and
combustibility of aerosols.
55. Filtration of a solution to a high degree of clarity
A. Polishing
B. Dialysis
C. Clarification
D. Dissolution
Polishing may be accomplished in several ways:
1.) by settling and subsequent decantation
2.) by centrifugation
3.) by filtration
Filtration is the only practical method when large
volumes of liquid are involved.
The term clarification applies when the solid do not
exceed 1.0% and filtrate is the primarily product.
56. This part of the tablet compression equipment stores
materials to be compressed
A. Hopper
B. Feed frame
C. Die
D. Punch
 Hopper - for storing the materials for compression
 Feed frame - for distributing the materials into the
dies
 Dies – for controlling the size and shape of the tablet
 Punches – for compacting the materials within the
dies; they also shape the tablet
PRACTICE SET 9. The insoluble dyes or lakes used for coloring tablets
contain
1. An inert gas that is usually incorporated in ampul A. Aluminum hydroxide
A. Hydrogen B. Potassium hydroxide
B. Oxygen C. A and B
C. Nitrogen D. Ferric oxide
D. Ethylene oxide
10. Which method of producing granules is best suited for
2. A document which gives a detailed instruction or receipt non-volatile fatty acids?
for a product to be manufactured is the A. Slugging
A. Prescription B. Spray drying
B. Formula order C. Spheronization
C. Master formula D. Spray congealing
D. Compound sheat
11. Powdered and granulated products have the following
3. Parenteral substances are filtered for advantages except:
A. Clarification A. Recommended for dispensing potent drugs with a low
B. Filtration dose
C. Obtaining polished solution B. Suitable for drugs which are inactivated in the stomach
D. Any of the above C. None of the above
D. As convenient as liquid products
4. Smallest size for hard gelatine capsules is
A. 000 12. Gradual sedimentations in liquid product is due to:
B.5 A. Chemical reaction
C. 3 B. Decomposition
D. 1 C. Bacterial growth
D. Any of the above
5. Type of emulsion which is potentially useful for prolonged
action or parenteral preparations 13. Gradual sedimentation is due to:
A. o/w A. Exposure to light
B. w/o B. Incompatibilities
C. Multiple emulsion C. A and B
D. Any of the above D. NOTA

6. Control limit within 3 standard deviation of the mean 14. The responsibility of an organization to determine that
A. Acceptable limit system facilities and written procedures are both adequate
B. Warning limit and followed in final dosage form all the applicable
C. Action limit specifications
D. Any of the above A. Quality control
B. Quality assurance
7. Manufacturing tanks of most pharmaceutical liquids C. Both A and B
should be made of D. NOTA
A. Galvanized iron
B. Glass 15. The quality of a medicinal and related product is the sum
C. Stainless steel of all factors which will contribute directly or indirectly to the
D. Plastic products:
A. Safety
8. The tank used in compounding ointments is B. Effectiveness
A. Transport C. Acceptability
B. Steam jacketed D. AOTA
C. Storage
D. All of the above 16. Factors that accelerate instability include
A. Gravity
B. Agitation
C. Packaging
D. AOTA
 25. The QC manager is in-charge of the following sections
17. Factors that accelerate instability include: except:
A. pH A. Specification and analytical development
B. Humidity B. Analytical laboratory
C. Radiation C. Research and Development section
D. AOTA D. Biological testing

18. Any unknown random cause which is inevitable and can 26. Total quality means:
be predicted A. Production is responsible for quality
A. Change cause B. QC’s strict adherence to standards
B. Assignable cause C. Quality is everybody’s business
C. AOTA D. AOTA
D. NOTA
27. The following are functions of the specifications and
19. Fines are used to analytical development section except:
A. Fill interparticulate spaces A. To develop new assay methods for in-house use
B. Form bridges between tablets B. To furnish data that will aid in analyzing product
C. NOTA performance in the market
D. A and B C. To validate existing and tentative procedures for testing
D. To coordinate with research, production, sales and
20. Flowers of sulfur is prepared by: management towards improvement of a product.
A. Sublimation
B. Evaporation 28. Standard operating procedure is:
C. Filtration A. A step by step method on how to go about a job
D. Precipitation B. Done to facilitate recall
C. Concerned with record keeping
21. Cerates are made by: D. AOTA
A. Maceration
B. Fusion 29. One of the following is used as a clarifying agent for liquid
C. Emulsification preparations:
D. Ignition A. Parabens
B. Citrates
22. Rule of thumb is for testing C. Gelatin
A. Ampules D. PEG
B. Hypodermic tablets
C. Compressed tablets 30. Investigations on specific physiological action of a
D. Tablets substance that affects life’s processes, isolation, such as
enzymes, vitamins, hormones, etc.
23. Provides sterile environment for a confined space: A. Pharmaceutical Research and Development
A. Laminar flow hood B. Pharmacological Research
B. Air filter C. Clinical Research
C. UV light D. Biochemical research
D. Gamma radiation
31. Department in a pharmaceutical firm that conducts
24. To control raw material and finished products in the check-ups of its employees preparation of “literature” or
warehouse, the practice of: “package inserts” and publication of clinical researches and
A. First in, first out investigations
B. Statistical quality control A. Medical Department
C. Last in, first out B. Personnel Department
D. AOTA is strictly d0ne C. R and D Department
D. Pharmacological Research
32. The complete obstruction or elimination of microbial life: 40. Presentation samples of all pharmaceutical products
A. Asepsis should be kept by Quality control and monitored yearly for
B. Disinfection sign of deterioration. The length of time these samples
C. Sterilization should be stored:
D. Sanitation A. I year
B. 2 years
33. Which of the following drug substances is not suited for C. 3 years
powder dosage form? D. 1 year after expiration date of the product
A. Anhydrous material
B. Eutectic mixture 41. Functions of package include:
C. Bulky materials A. To provide presentation
D. Efflorescent materials B. To provide containment
C. For communication
34. Using a sampling plan by square root system, the sample D. AOTA
size required for 90 containers of Ascorbic acid powder is:
A. 9 containers to be sampled 42. Amaranth USP is used in pharmacy as a/an:
B. 10 A. Flowering agent
C. 11 B. Preservative
D. 7 C. Coloring agent
D. Anti-oxidant
35. Antibiotics and insulin products can be released for
distribution by: 43. The number of linear openings per square inch
A. Quality control of the company A Sieve
B. Marketing department of the company B. Mesh
C. FDA C. A and B
D. AOTA D. NOTA

36. The percentage allowance for error in high speed 44. Suppositories which are administered vaginally
automatic filling machine is: A. Bougies
A. 0.5 – 1.0 % B. Pessaries
B. 3.0 – 5.0% C. A and B
C. 0.10% D. NOTA
D. 102.0%
45. Areas of concern during production of parenterals include
37. Pfizer tester that determines force to break a tablet is to A. Production facilities
measure disintegration: B. Components
A. Hardness C. Production procedures
B. Thickness D. AOTA
C. Friability
D. Disintegration 46. Material of choice for uniforms used in parenteral
production
38. This dosage form does not have to conform with USP A. Cotton
disintegration time B. Rayon
A. Film tablet C. Linen
B. Sugar coated D. Dacron
C. Enteric coated tablet
D. Chewable tablet 47. Package component used to counteract moisture
brought to the container system
39. Minimum satisfactory hardness of tablets A. Coil
A. 2kg B. Dessicant
B. 3 kg C. Closure
C. 4 kg D. AOTA
D. 5 kg
48. Lubricants may be added through ANSWER KEY:
A. Bolting 1. C 26. C
B. Spraying 2. B 27. B
C. A and B 3. D 28. A
D. NOTA 4. B 29. C
5. C 30. D
49. The USP recommended excess for multiple dose 6. A 31. A
parenterals 7. C 32. C
A. 1-3% 8. B 33. B
B. 6-8% 9. A 34. B
C. AOTA 10. D 35. C
D. NOTA
11. D 36. C
12. D 37. D
50. Punches in tablet making control
13. C 38. D
A. Hardness
14. B 39. A
B. Size and shape
C. Solubility 15. D 40. D
D. Color 16. D 41. D
17. D 42. C
18. A 43. B
19. D 44. B
20. A 45. D
21. B 46. D
22. C 47. B
23. A 48. C
24. A 49. B
25. C 50. B