Quality Control Tests Of

TABLETS
 QUALITY CONTROL
TESTS OF
TABLETS

PHYSICAL CHEMICAL
TESTS TESTS

2: Tablet
1: Hardness an
Thickness 1: Content 2:
Test d
Diamet Uniformity Assay
er

4: 5: Weight
3: Friability 3: Dissolution
Disintegration
Tes Variation
Tes
Test Test
t t
 Hardness
 It is defined as the force required to
break a tablet in a diametric
compression test.
 Tablet requires a certain amount of
strength or hardness and resistance to
friability to withstand mechanical
shakes of handling in manufacture,
packaging and shipping.
 Tablet Hardness Test is performed to
check that the manufactured tablet is
• If the tablet is too hard it may not disintegrate, if
the tablet is too soft it may not be able to
withstand handling during subsequent processes
such as coating, packaging & shipping operations.
• The force require to break the tablet is measured
in kilograms & crushing strength of 4kg is usually
considered to be minimum for satisfactory tablets.
• Oral tablets normally have a hardness of 4-10kg.
• Hypodermic & chewable are usually much softer
i.e 3kg
• Sustained release tablets have hardness of 10-20
kg.
 Hardness
Testers
1. Strong-Cobb
2. Stokes-
Monsanto
3. Eureka
4. Pfizer
 1:Strong-
• Cobb
The tablet is
placed
between two
jaws that
• crush the
tablet.
The machine
measures the
force applied
to the tablet
and detects
when it
 2:Stokes-Monsanto
 Tube like
structure in
which tablet is
placed.
 Force in kg is
required to
break tablet.
 4kg is general
range
 3:
Eureka
The breaking force is applied by a beam
fastened to one end to a pivot
 The motor moves a weight along the
beam at a constant speed and increases
the force against the tablet on which the
other end of the beam rests
 When the tablet breaks, a microswitch is
activated that stops the motor
 An indicator fastened to the weight
shows the breaking strength on scale in
kilogram units
Eureka
instrument
4:
Pfizer
 Factors Affecting
Hardness
 Pressure applied during the
compression
 Cohesive forces between
ingredients especially binder have
more cohesive forces
 Density
Thickness and Diameter
 Tablet thickness and diameter tests are
very important qc tests
also
 Very thick tablet affects packaging either
in
blister or plastic container
 The thickness for majority of tablets may vary
from 2mm to 4mm
 The diameter of tablets may vary from 4mm to
13mm
 Instruments used
 For diameter: Vernier
Calipers
 For thickness: Micrometer Screw Gauge
 Friability
►Itis the tendency of tablets to powder,
chip, or fragment and this can affect
the elegance appearance, consumer
acceptance of the tablet, and also
add to tablet’s weight variation or
content uniformity problems.
►Friability is a property that is related
to the hardness of the tablet.
►An instrument called friabilator is
used to evaluate the ability of the
tablet to withstand abrasion in
packaging, handling, and shipping.
 Friabilator

►Friabilator is a round drum.

►It has diameter of 2.87mm and depth

of 38mm.
►In diameter a horizontal axis is
present.
►Friabilator is connected to timer to

indicate its rotations.

►It is rotated in clockwise direction.
 Rotating
drum

Time
r
 Test Method
►Weigh 20 tab altogether = W1
►Put these tablets in the friabilator and
adjust the instrument at 100 rpm (i.e. = 25
rpm for 4 min)
►Weigh the 20 tablets (only the intact
ones) = W2
►The difference between W1 and W2 gives
weight loss (i.e. Friability)
►Weight loss of less than 0.8% is
acceptable
Disintegration
Disintegration
apparatus
Glass
Tube
s
 Disintegration
test is with
performed
different types
1. Uncoated of
tablets
tablets
2. Coated tablets
3. Enteric coated
tablets
4. Buccal tablets
5. Sublingual
tablets
 Different liquid
mediums
used in are
 disintegration
Water test
 Simulated gastric fluid
(PH= 1.2)
 Simulated intestinal fluid
(PH= 7.5)
SIMULATED GASTRIC
FLUID
 Sodium chloride
-------------------- 2gm
 Pepsin
-------------------------------- 3.2gm
 Hydrochloric acid
------------------ 7ml
 Water (q.s to make)
--------------- 1000ml

SIMULATED INTESTINAL
1: Test method for
Uncoated tablets
2: Test method for coated
tablets
 3: Test method for
Enteric coated
tablets
Place 1 tablet in each of the 6 tubes of
the basket, add a disk to each tube.
Put in distilled water for five minutes to

dissolve the coat.

Then operate the apparatus without the

disks using simulated gastric fluid as

immersion fluid maintained at 37C for one
hour.
After one hour, lift the basket and

observe the tablets, the tablets show no

 Then add disk to each tube and
operate the apparatus using
simulated intestinal fluid maintained
at 37°C for two hours.
 If one or two tablets fail to
disintegrate, repeat this test on
another 12 tablets.
 So 16 tablets from 18 should
completely disintegrate.
 If more than two fail to disintegrate
the batch must be rejected.
4: Test method for
Buccal tablets
5: Test method for
Sublingual tablets
Factors Affecting
Disintegration
 Quantity of disintegrating

agent
 Compactness
 Cohesive forces between the
ingredients
 Hardness
 Weight Variation
 The actual weight of a tablet is determined by
the diameter of the die and the weight
adjustment cam on the tablet machine
 The weight control on the tablet machine is
routinely adjusted at intervals to ensure that
the specified weight is being reproduced
 This test is perform to ensure uniform
distribution of ingredients throughout batch
 Test Method
 Take 20 tablets
 Weigh individually
 Determine the average weight of 20 tablets
 Compare individual tablet weight to average
weight
 Not more than 2 of the individual weights
deviate from the average weight by more than
the percentage deviation
 And none deviates by more than twice that
percentage.
Weight variation tolerances
for
uncoated tablets in U.S.P
XVII
Average weight of Percentage Differences
Tablet (mg) 130 or less 10.0

130-324 7.5

More than 324 5.0

Causes of Weight
Variation
1. Poor flow of granules
2. Variation in size of granules due to
improper sieving
3. Presence of very fine granules
4. Improper adjustment of machine
5. Improper flow rate
 Content Uniformity
• The content uniformity test is used to
ensure that every tablet contains the
amount of drug substance intended with
little variation among tablets within a
batch.
• The individual variation in drug content
might result from a failure to maintain the
homogeneity of a tablet granulation
through the processing steps leading to
compression.
 Test
• Method
30 Tablets are kept aside .
• 10 tablets are assayed .
• 9 Tablets should have %limit of 85-115%
of average of tolerances specified in
respective monograph .
• If more than 1 Tablet has 85-115% then,
20 Tablets are assayed Not more than 1
Tablet should have 75-125%
 Assay
• Assay is performed in finished form to
know the amount or concentration of
active ingredients present in tablets
• It include HPLC, spectroscopy, chemical
tests etc
 Test Method
STAGE-1
•Weigh about 20 tablets and crush
them
•To aliquot add 30ml (0.5N) NAOH
•Titrate the mixture with 0.5N HCl
•Use phenol red as indicator
•The point at which red color turns to
yellow indicates the end point and the
amount of HCl used is noted
 STAGE-2

•Repeat the titration with blank solution of 30ml

(0.5N) NaOH
•Calculate the difference of HCl consumed in
both titrations.

• NOTE: Each ml of 0.5N NaOH is equivalent to

0.04502gm or 45mg of active ingredient
 Formulae
• Weight of 1 tablet = Total weight of tablet
number of tablets

• Aliquot = Total weight of 1 tablet × Required amount

Active (claimed)

• %age purity = volume consumed x average weight

of tablets x factor x100 active (labelled claimed) x
aliquot
 Dissolution
• The release of drug from the tablet into
solution per unit time under standardize
condition is called dissolution test.
 Dissolution Apparatus
1. Rotating basket method
APPARATUS-I
2. Paddle method APPARATUS-II
3. Reciprocating cylinder method
APPARATUS-III
4. Flow through cell method APPARATUS-IV
5. Paddle over disk method APPARATUS-V
6. Cylinder method APPARATUS-VI
7. Reciprocating disk method APPARATUS-
VII
 1:Rotating basket method
APPARATUS-I
•The apparatus consists of a cylindrical
basket held by a motor shaft
•The basket holds the sample and rotates in a
round flask containing the dissolution medium
•The entire flask is immersed in a constant
temperature bath set at 37°C
•The rotating speed is 100 rpm.
•Used for Immediate release, chewable &
controlled release tablets
 2: Paddle method
APPARATUS-II
•The apparatus consists of a special, coated paddle
that minimizes the turbulence due to stirring
•The paddle is attached vertically to a variable speed
motor that rotates at controlled speed
•The apparatus is housed in constant temperature
water bath maintained at 37°C
•Rotating speed is 50 rpm for solid dosage forms
•Used for chewable & controlled release tablets and
suspensions
Paddl
e
3: Reciprocating cylinder method
APPARATUS-III
•The apparatus consists of
a set of cylindrical, flat
bottomed glass vessels
•Temperature maintained
at 37°C.
Operated at 6-35rpm
•Used for dissolution
testing of extended released products
 4: Flow through cell method

APPARATUS-IV
•The apparatus consists of a reservoir for
dissolution medium and a pump that forces
dissolution medium through cell holding the
test sample
•Flow rate ranges from 4 to 16ml/min
•Temperature maintained at 37°C
•Used for low solubility drugs, implants,
suppositories, controlled release formulations.
Flow through cell method
 5: Paddle over disk method
APPARATUS-V
•The apparatus consists of a sample holder or
disk assembly that holds the product
•Temperature maintained at 32°C
•Operated at 25-50rpm
•Used for transdermal
products
 6: Cylinder method

APPARATUS-VI
•It is modified basket method
•In place of basket, a stainless steel
cylinder is used to hold the sample
•Temperature maintained at 32°C
•Used for transdermal products
 7:Reciprocating disk method
APPARATUS-VII
•A motor drive assembly is used to reciprocate
the system vertically and sample is placed on disk
shaped holders
•Temperature maintained at 32°C
•Operated at 30rpm
•Controlled tablets
•Transdermal products
 Test Methods
• Place 900ml of dissolution medium in the vessel,
which previously has been immersed in the
constant temperature bath, and allow the
dissolution medium to come to a temp: of 37C.
• Place one tablet in the basket.
• Assemble the apparatus, and immerse the basket
at a distance of 2 cm from the bottom of the
vessel.
• Rotate the basket at a rate specified n the
individual monographs.
• Withdraw the sample at the time indicated and analyze
them by the general procedure given in individual
monographs.
• Repeat the test on five additional tablets meet the
requirements specified in the individual monographs.
• If 1 or 2 tablets fails to meet the requirements repeat the
test on 6 additional tablets.
• Not less than 10 of the 12 tablets meet the requirements.
• Note: Unless otherwise directed maintain the volume in
the vessel constant by adding a volume of dissolution
medium equivalent to that removed for sampling
purposes.
Quality Control Tests of
CAPSULES
 Capsule
• A capsule is a solid dosage form in which the drug is
enclosed in a hard or soft soluble container, usually
of a form of gelatin.
• Hard capsules are used for filling the solid
substances.
• Soft capsules are used for filling the liquids &
semisolids.
• Hard capsules come second to tablets in
importance as a solid unit dosage forms.
• Some of the capsules are administered through
rectum or vagina.
• Hard capsule shells are made up of two cylindrical
halves, one slightly large in diameter but shorter in
length is called as cap, other larger in length &
shorter in diameter is called as body.
• The drug is filled in body over which the cap is fitted.
• There are different sizes of capsules varies from 000
to 5.
• 000 is larger size where as 5 is smaller in size.
• The soft capsule are available in different shapes
such as Spherical, Ovoid, Cylindrical & Tubes.
• The spherical are also known as pearls.
 Quality
Control
Tests
Of
CAPSULES

2: Uniformity
1: Disintegration of Weig
test ht
 Disintegration of
Capsules
• The disintegration of capsules is different
from those of tablets because the
determination of end point is difficult owing
to the adhesive nature of shell.
• The shell pieces after disintegration may
agglomerate forming large mass of gelatin
taking more time to dissolve and may
adhere to the mesh thus, blocking the
holes.
 Test method
• Place one capsule in each of the tubes of the
basket with water or any other specified
medium maintained at 37C.
• Attach a removable wire cloth with a plain
square weave of 1.8-2.2 mm of mesh aperture
and a wire diameter of 0.60-0.655 mm to the
surface of upper rack of the basket assembly.
• Observe the capsules for a time limit
• At the end of prescribed time, all of the
capsules must have been disintegrated
excluding the fragments from the capsule
shell.
• If 1 or 2 capsules fail, the test should be
repeated on additional of 12 capsules.
• Then, not fewer than 16 of the total 18
capsules tested should disintegrate
completely.
 Types of Capsule
• Hard Gelatin Capsule
• Soft Gelatin Capsule
 Test Method A: For Hard
Gelatin Capsule
•Take 20 capsules and weigh individually
•Empty the capsules and weigh their shells
(made up of gelatin)
•Take the differences of these two weights
•Differences between the weights represents
weight of the contents
•Calculate the average weight of the contents of
20 capsules
• The weight of the contents of each capsule
does not deviate from the average weight
by a greater percentage than shown in
column A
• For two capsules, the weight of the
contents may deviate by not more than the
percentage shown in column B
 Weight variation tolerances for
capsules
Average
Weight Percentage Deviation

A B
0.120 g or less
10%
20%
More than 7.5% 15%
0.120 g
 Test Method B: For Soft Gelatin
Capsule
•Take 20 capsules and weigh individually
•Weigh a capsule, open it without loss of
shell material
•Express as much of the contents as
possible
•Wash the shell with solvent ether, reject
the washings, allow the shell to stand until
ether is completely evaporated and odour
of ether is no longer perceptible
•Then weigh the empty shell
• Calculate differences between weigh of
each capsule and that of empty shell
• The differences between weights
represents the weight of the contents
• Calculate the average of the weight of the
contents of 20 capsules
• the weight of the contents of each
capsule does not differ from the average
weight by more than 7.5%
•Except that for one capsule the weight
of the contents may differ by not more
than 15%