Quality control tests for tablets Quality control tests for tablets

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QUALITY CONTROL TESTS FOR TABLETS
Practice school report
Submitted to
Acharya Nagarjuna University, Guntur, A.P.,
In Partial Fulfilment of the requirement for completion of
IV/IV B. Pharmacy VII SEMESTER
Submitted By
S.SWAPNA Y18PH2011
Sk.M.KHUDDOOS Y18PH2068
S.PAVAN KUMAR Y18PH2070
T.VINAI SAI Y18PH2071
T.STALIN Y18PH2072
UNDER THE GUIDANCE OF
Dr.B.Ramarao, M.Pharm, (Ph.D)
Asist.Professor
Department of Pharmaceutical Analysis
MedermetlaAnjammaMastanrao College of Pharmacy
Kesanupalli (PO), Narsaraopet (M), Guntur (Dist), Pin: 522601, FEBRURARY- 2022

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DECLARATION
We hereby declare that the work incorporated in this thesis “Quality control tests for Tablets” has been
carried out at M.A.M College of Pharmacy, Narasaraopet, A.P, and India. The work is original and has
not been submitted in part or full for any other Institutes, during the academic year 2021- 2022
Place:
Date:
PRACTICE SCHOOL ASSOCIATES:
S.SWAPNA Y18PH2011 ------------------------------
SK.M.KHUDDOOS Y18PH2068 ------------------------------
S.PAVAN KUMAR Y18PH2070 ------------------------------
T.VINAI SAI Y18PH2071 ------------------------------
T.STALIN Y18PH2072 ------------------------------

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MEDARAMETLA ANJAMMA MASTAN RAO COLLEGE OF
PHARMACY
Kesanupalli, Narasaraopet, A.P, India
Affiliated to Acharya Nagarjuna University and Recognized By AICTE&PCI
.
ENDORSEMENT CERTIFICATE BY THE PRINCIPAL
This is to certify that the dissertation entitled “Quality control tests for Tablets” is genuine carried
out by and submitted in partial fulfilment of the requirements for completion of IV B.Pharmacy
VII sem to Acharya Nagarjuna university Guntur, A.P .Under the guidance of
Dr.B.Ramaraoduring the academic year 2021- 2022
Place
Date:
Principal
Dr.M.Prasada Rao., M.Pharm, Ph.D.

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MEDARAMETLA ANJAMMA MASTAN RAO COLLEGE OF
PHARMACY
Kesanupalli, Narasaraopet, A.P, India
Affiliated to Acharya Nagarjuna University and Recognized By AICTE&PCI
.
ENDORSEMENT CERTIFICATE BY THE GUIDE
This is to certify that the dissertation entitled “Quality control tests for Tablets” is genuine carried out by
and submitted in partial fulfilment of the requirements for completion of IV B.Pharmacy VII sem to
Acharya Nagarjuna university Guntur, A.P .Under My Supervision,during the academic year 2021- 2022
Place:
Date:
GUIDE
Dr.B.RamaraoM.Pharm, (Ph.D)
Asist.Professor
Department of Pharmaceutical Analysis

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Evaluation Certificate
This is to certify that the dissertation entitled “Quality control tests for Tablets” is genuine carried out
by and submitted in partial fulfilment of the requirements for completion of IV B.Pharmacy VII sem to
Acharya Nagarjuna university Guntur, A.P .Under My Supervision,during the academic year 2021- 2022
Place :
Date :
Signature of the Internal Examiner : Signature of the External Examiner :
QUALITY CONTROLTESTS FOR TABLETS

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DEFINITION:
Tablets are solid dose pharmaceutical
preparation containing drug substances usually
prepared with the aid of suitable pharmaceutical
excipients. They may vary in size, shape, weight,
hardness, thickness, disintegration, and dissolution
characteristics and in other aspects, depending on their
intended use and method of manufacture.
Tablets are prepared primarily by
compression of granules or powder blends, with a
limited number prepared by moulding. Most tablets are
used in the oral administration of drugs. Many of these
are prepared with colourants and coatings of various
types. Other tablets, such as sublingual, buccal, or
vaginal tablets, are prepared to have features most
applicable to their particular route of administration.
GENRAL PROPERTIES:
• A tablet must be strong and hard to withstand
mechanical shock during manufacturing,
packing, shipping, dispensing and use.
• The drug content of the tablet must be
bioavailable that is, the tablet must be able to
release its content in a predictable and
reproducible manner.
• The tablet must be chemically and physically
stable to maintain its chemical and physical
attributes during manufacture, storage, and use.
• The tablet should have elegant product identity
which is free from any tablet defect.

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• Tablets must be uniform in weight and in drug
content.
ADVANTAGES:
• Uses low concentration of the therapeutic agent
• Reduces intra and inter-batch variability due to
decrease in segregation of formulation
components during storage and processing
• Not dependent on the inclusion of special grades
of excipients
• Tablets are responsive to post-processing unit
operations
DISADVANTAGES:
• Usage of various solvents may lead to drug
degradation
• Enhances the hardness of the granule
• Application of heat might degrade the
thermolabile therapeutic agents.
TYPES OF TABLETS:
• Compressed tablets.
• Sugar-coated Tablets.
• Film-Coated Tablets.
• Effervescent Tablets.
• Enteric-coated Tablets.
• Chewable Tablets.
• Buccal and Sublingual Tablets.
QUALITY CONTROL TEST METHODS:

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The concept of tablet quality control refers to the
produce a perfect product by a series of measures
requiring an organized effort by the entire company to
prevent or eliminate errors at every stage in production.
Although the responsibility to assuring product quality
belongs principally to quality assurance. It involves
many departments disclaimed lines with in a
company.to be effective it must be supported by team
effort.
Quality must be built in to a drug product
during process design, and it is influenced by physical
plant design, space, ventilation, cleanness and sanitation
during routine production.
The product and process design begins in
research and development, and includes preformulation
and physical, chemical, therapeutic and toxicological
consideration.
It consider material, in process and product
control, including specification and test for the active
ingredients, the excipients and the product itself
specific, stability procedure for the product, freedom
from microbial contamination and proper storage of the
product and containers, packaging and labelling to

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ensure that container closure systems provide
functional protection of the product against such factors
as moisture, light, temperature, drug or packaging
interactions
Provision are a cross referencing system to allow
any batch of a product to be traced from its raw material
to its final destination in the event of unexpected is
required.
TESTING METHODS: -
A.Physical examination
B.Thickness&Diameter
C. Weight variation
D.Hardness
E.Friability
E.Disintegration test
F.Invitro dissolution
PHYSICAL EXAMINATION: -
Ten tablets were removed from the sheet and
carefully examined by naked eye to detect
the physical properties the method under
five parameters they are oAppearance
oColouroBrack line oAny cracked edges
oAny deformations

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The process was repeatedly performed for each type
of paracetamol tablets different company’s
REPORT: -
Physical evaluations process was preformed repeatedly
& the tablets preferably passed the test
THICKNESS&DIAMETER: -
REQUIREMENTS:
Tablet
Equipment’s-verniercallipers
PRINCIPLE:
The thickness of individual tablets is measured with a
micrometre, which gives us Na information about the
variation between tablets. Tablet thickness should be
within a +5% variation of a. standard value. Any variation
in thickness within a particular lot of tablets between
manufacturer's lots should not be clear to the unaided eye
for consumer acceptance of the product. In addition,
thickness should be controlled to smooth the progress of
packaging.
PROCEDURE:
Uniformity of thickness: To determine the uniformity of
thickness random selection of tablets has to be done from
each and every batch and need to measure its thickness
independently. If the thickness of any single tablet varies
then the batch containing that batch will not be
dispatched into market.

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NOTE: Hence the resulting values of thickness test are in
the limits there by the test is passed.
REPORT: -
Thickness of the tablet was found to be±5% by using
vernier caliper is depending upon the size.
WEIGHT VARIATION: -
PRINCIPLE:
The tablet is designed to contain specific amount of
tablet granules. The weight of tablet is measured to
ensure that the tablet contains proper amount of drug.
This test is a method of determining the drug content
uniformity of tablet.
PROCEDURE:
The weight variation test must be done by weighing 20
tablets individually. Calculate the average weight and
compare the individual weight to the average weight.

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The tablet passes the test, if not more than 2 tablets or
outside the % limit and no tablet differ by more than 2
times the % limit
NOTE:
S
no.
AVERAGE
WEIGHT
% Weight variation
allow
1 130mg or less ±𝟏𝟎%
2 130mg-324mg ±𝟕. 𝟓%
3 More than 324mg ±𝟓%
REPORT: - weight variation test was performed for a
given marketed sample and values are matched with
the limits, so that it passes test.
HARDNESS:-(CRUSHING STRENGTH)

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PRINCIPLE:
Tablets requires certain amount of hardness and
resistant to friability to withstand the mechanical shock
by handling and during manufacturing, packaging and
shopping.
To monitoring the tablet, hardness, the hardness tester
is to be used which is helpful to detect the problem that
are sensitive to dissolution, potential bioavailability. The
strength of tablet hence determined by breaking it
between 2nd and 3rd finger with the thumb acting as
fulcrum, with the help of Monsanto hardness test. The
tablet hardness has been designed as the force required
to the tablet in diameter(compression).
PROCEDURE:
The hardness of the tablet is tested using the
hardness tester. The tablet is placed across the diameter
in between the strindle and angle the knob is adjusted to
hold the tablet in position the reading of the pointed is
adjusted is zero. The pressure is increased slowly to break
the tablet. Hardness factor the average of several
determinations is determined and reported
FACTORS INFLUECING THE HARDNESS: -
• Compression of the tablet and compressive
force
• Amount of binder (more binder a more
hardness)
Method of granulation in preparing the tablet
(Wet method gives more hardness than direct

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method, slugging method gives the best
hardness)
• Hardness is dependent on ductility, elastic
stiffness, plasticity, strain, strength,
toughness, viscoelasticity and viscosity
• The selection of hardness test method and
acquired results are dependent on hardness
of the item
surface,roughness,dimensions,shape,process
ing type before measuring and the conditions
of exploitation.
• The hardness of carbon steel can be effected
by a number of different factors,including the
carbon contact the amount and type of other
elements in the alloy,and these specific
process used to create the steel
• The hardness governed the dissolution over
all the stages from tablet to the smallest
particles after the breakage by disintegration.
UNITS OF HARDNESS:-
• The SI unit of hardness is N/mm sq
• The unit pascal is thus used for hardness as
well but hardness must not be confused with
pressured

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• The different types of tablets discussed above
have different scales of messurement.
HOW DO YOU CHOOSE A HARDNESS TEST:-
When selecting a hardness test method important
considerations include:-
• The type of material to be hardness tested
• The approximate hardness of material
• The size of the part
• Whether mounting is necessary
• The homogeneity and heterogeneity of the
material NOTE:
Official standards for Hardness:
• 5-8 kg/cm2 for standard compressed tablet
except Effervescent tablet,Chewabletablet,etc.
• More than 8-12 kg/cm2 for Sustain released
tablet and controlled release tablet. Tablet
Dispersible tablet,Orodispersible
REPORT:-
The hardness of tablets was performed and it
was found to be 10kg per cm2
FRIABILITY:
PRINCIPLE:

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It is a property to finding the hardness of the tablet. The
tablet hardness is not as absolute indication of strength,
since some formulations tends to loss there capping
when compressed to very hardness tablets i.e.friability is
often measured, the tablet tend to powder, chipand
fragment themselves, leads to consumer inacceptance
and creates problem when coding, packing and shipping,
such tablets produced large proportion of dust during
subsequent test lead to weight variation and content
uniformity and lack of consumer acceptance due to poor
appearance.
Procedure:-
ROCHE friabula is used to measured the friability
tablet it rotates at a rate of 20rpm 20 tablets weighed
collectively and placed in chamber of fgribulata.the
tablets are exposed to rolling,resulting from free fall of
tablet with in the chamber of friabular .
After 100 free falls (rotating for25rpmk for 8
min)the tablets are taken out from fribulata and
intact tablets are again weighed collectively.
Percentage friability is determined using following
formula
Friability%=W1-W2

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-----------*100
W1
W1=weight of tablet before tesr
W2=weight of tablet after test
NOTE: Standards for friability: % Friability
should be upto 0.5 to 1% for all standard
compressed tablets.
REPORT:-The friability test was conducted and
friability of a given tablet is found to be
DISINTEGRATION TEST:-
PRINCIPLE:
Generally accepted medium for the drug
readily available for the body must be taken as a
solution. The term disintegration is
defined as the breakdown of solid dosage form
into small particles after its administration. The time
taken by the tablet to disintegrate is know as
disintegration test was to be found out by using
disintegration test apparatus and the device described in
the usp or national formulary. The usp device used for
this purpose has 6 glass tubes that are in 3 inches long.
PROCEDURE:

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In the test for disintegration time the tablet is placed
in each test tubes(6 test tubes) and this set is placed in 1
litre beaker filled with experimental fluid (water,
simulated gastric or intestinal fluid );at 37oc.such tablet
remains 2.5 cm below the surface of the liquid on upward
movement and 2.5cm away from the bottom and there
downward movement. The perforted plastic disc is placed
in each of glass tube over the tablets to prevent them from
floating.
The motor driven device is present at the top of upper
plastic plate to move the assemble of glass tube up and
down through a distance of 5-6cm at constant frequency
(28-32 cycles per min). Then a tablet must disintegrate
when all the particle passes through mesh screen within
time specified NOTE:
Disintegration test: we start with 6 tablets (each tablet in
each tube), if one or two tablets failed to disintegrate
completely, test should be repeated for additional 12
tablets, the requirement met if not fewer than 16 of the
total 18 are disintegrated
REPORT:
The disintegration test of the given tablet was
performed and is to be found out as
minutes
DISSOLUTION TEST:
CHEMICALS:

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Paracetmol tablet, phosphate buffer pH-6.8, distilled
water.
GLASS WARE: Volumetric flasks-1000ml, 10ml,
beakers, pipettes etc
INSTRUMENTATION:
USP dissolution apparatus 2-paddle, UV- visible
spectrophotometer with matched quartz cells
PRINCIPLE:
Dissolution testing is an important tool for
characterizing the performance of oral solid dosage
forms. It significance is based on the fact that for a drug
to be effective, it must first be released from the product
and dissolve in the gastro intestinal fluids before
absorption into the blood stream can happen
DISSOLUTION STUDY PROCEDURE :
1. Switch the heater of the dissolution device on and
manage the temperature to reach 37oc.
2. Wash the vessel (of dissolution apparatus) using
water and soap then put 90ml of medium
(phosphate buffer pH-6.8) in each.
3. Elevate the paddle 25± 2 mm from the bottom of the
vessel.
4.Operate the paddle on a rotation speed equals to
50rpm.

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5. Add one 500mg tablet in one vessel which you
previously cleaned and at once starting timing.
6.At speed time intervals(0,5,10,20,40,80,120 min)
with draw 1ml using the volumetric pippete from
each filtrated the sample (filtrate) and put it in 10ml
volumetric flask (clean and neat), them complete
the volume upto 10ml by the medium (phosphate
buffer at pH =6.8).
7. Replace the same volume into dissolution vessel by
another volumetric pippete.
8.Read the absorbance of the diluted sample solutions
at λ=243nm using the buffer as a blank.
9.Plot a graph between time intervals on x-axis vs %
of drug release on y-axis.
10. Find out the slope , concentration, amount of
drug release, % of drug release and report it
NOTE:

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Dissolution testing and interpretation IP standards
S
no
Quantity
stage/
level
Number
of
tablets
tested
Acceptance criteria
1 S1 6 Each unit is not less
than Q*+5 percent**
2 S2 6 Average of 12 units
(S1+S2)is equal to or
greater than (>)Q,
and no unit is less
than Q-15 percent **
3 S3 12 Average of 24 units
(S1+S2+S3) is equal
to or greater than
(>)Q, not more than
2 units less than Q 15
percent**and no unit
is less than Q-25
percent**
Q is the amount of dissolved active ingredient
specified in the individual monograph, expressed as a
percentage of the labelled content.
**percentages of the labelled content.

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REPORT:-
The dissolution test were performed , The
percentage of drug content release was found to
be93.06 for 120min.