Quality control Tests for

tablets: In-Process and

Finished Product
What is IPQC ?
IPQC is concerned with providing accurate, specific, and
definite description of procedures to be employed from
the receipt of raw materials to the release of finished
dosage forms.
IPQC Procedures are generally quick, sipmle and
rapid tests or inspection that carried out at on going
manufacturing .
It is a planned system to identify the
materials, equipment, process, and
operations.
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Why we need IPQC?
To detect the errors
To minimize the human errors.
Provides accurate, specific, and definite description of
the procedure to be employed.
Rigidly followed.
Should detect any abnormality immediately and at the
same time indicate the kind of action needed to correct
the problem.
To enforce the flow of manufacturing and
packing operations according to established
routes and practice.

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Who do IPQC?
Usually, the tests are carried out by production
personnel. This is favourable for organizational and
timely reasons, e.g. in a multi-shift operation.
The personnel in production area referred to here
do not have to be directly responsible to the head of
production with disciplinary responsibility.
 On the basis of organisational instructions and
process descriptions, quality control personnel
may also carry out the necessary tasks.

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Where to to do IPQC?
In-process controls may be carried out within the
production area provided they do not carry any risk
for the production.”

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In-Process Quality Control tests for
Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister
packaging

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 Evaluation of Finished product
• Official tests:
1. Size and shape and appearance of tablet.
2. Friability
3. Content of active ingredient.
4. Uniformity of weight/weight variation test
5. Uniformity of content
6. Disintegration.
7. Dissolution.
• Unofficial test:
1. Hardness test.
1. Size, shape & appearance:
• General Appearance: The general appearance of a tablet, its identity and
general elegance is essential for consumer acceptance, for control of lot-
to-lot uniformity and tablet-to-tablet uniformity. The control of general
appearance involves the measurement of size, shape, color, presence or
absence of odor, taste etc.
• Size & Shape: It can be dimensionally described & controlled. The
thickness of a tablet is only variables. Tablet thickness can be measured by
micrometer or by other device. Tablet thickness should be controlled
within a ± 5% variation of standard value.
• Unique identification marking: These marking utilize some form of
embossing, engraving or printing. These markings include company name
or symbol, product code, product name etc.
• Organoleptic properties: Color distribution must be uniform with no
mottling. For visual color comparison compare the color of sample against
standard color.
Hardness
 It is the load required to crush the tablet when placed on its
edge.
 It determine the need for pressure adjustments on the
tableting machine.
 Hardness can affect the disintegration.
 So if the tablet is too hard, it may not disintegrate in the required
period of time.
 And if the tablet is too soft, it will not withstand the
handling during subsequent processing such as coating or
packaging.
 In general, if the tablet hardness is too high, we first check
its disintegration before rejecting the patch. And if the
disintegration is within limit, we accept the patch.
 If Hardness is high + disintegration is within time
-- accept the
batch 9
 Factor effecting Hardness
Compression of the tablet and compressive force.
• Amount of binder. (More binder à more hardness)
• Method of granulation in preparing the tablet (wet
method gives more hardness than direct method,
Slugging method gives the best hardness).
• Limits:
• Conventional tablets hardness: 2.5- 5 kg/sq cm
• Dispersible/ chewable tablets hardness: 2.25- 2.5 kg/sq cm
• Extended release tablets hardness: 5- 7.5 kg/sq cm
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Haedness testers
1. Monsanto tester
2. Strong-cobb tester
3. Pfizer tester
4. Erwica tester

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Friability
It is 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.

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How it determined
 Friability of a tablet can determine in laboratory by
Roche friabilator. This consist of a plastic chamber
that revolves at 25 rpm, dropping the tablets through a
Distance of six inches in the friabilator, which is then
operate for 100 revolutions. The tablets are reweighed.
 Compress tablet that lose less than 0.5 to 1.0 % of
the Tablet weigh are consider acceptable.
Friability (% loss) = W1 - W2/100
W1 = Initial Weigh 20 tablets
W2 = Weigh 20 tablets after 100 rotation

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Roche friabilator

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Thickness
The thickness of a tablet depends on the upper and
lower punches at the moment of compression. it can
be tested using vernier calipers. The range varies
with
+/- 5.0%. VERNIER CALIPERS

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 Disintegration test
• Disintegration of a tablet means to break a tablet into
smaller particles after swallowing. The time required to
disintegrate the tablet is called disintegration time. The
disintegration test is a measure only of the time required
under a given set of conditions for a group of tablets to
disintegrate into particles.
• The end point of the test (i.e. complete
disintegration) is achieved when no tablet
fragments remain on the screen. The preparation
complies with the test if the time to reach this
end-point is below given limit; < 30 minutes for
uncoated immediate release tablets. but varying
from 2 min for nitroglycerin sublingual tablets to
up to 4 hrs for buccal tabletsThe tablets pass the
test if all the tablets disintegrate.
1. In case one or two tablets fail to disintegrate, repeat the
test on 12 additional tablets. The tablets pass the test if
not less than 16 of the total 18 tablets tested have
disintegrated. 16
 Disintegration test
• The apparatus consists of a rigid basket-rack assembly
supporting 6 cylindrical glass tubes held vertically by two
superimposed transparent plastic plates with six holes
having the same diameter as the tubes. Woven wire gauze
made from stainless steel is attached to the underside of the
lower plate. The assembly should be raised and lowered
between 28 and 32 times per minute in the liquid at 370 C.
• The tablets are kept immersed in the liquid within the tubes
by means of cylindrical guided discs. The assembly is
suspended in the liquid medium in a 1000 ml beaker. The
apparatus is operated generally for 15 minutes and observed
for disintegration of tablets.
 Disintegration test
• For Uncoated tablets:
1. Start the disintegration test on 6 tablets, if one or two tablets from the 6
tablets fail to disintegrate completely within 30min, repeat the same test
on another 12 tablet.
2. Not less than 16 tablets should disintegrate completely within the time
and if more than two tablets (from the 18) fail to disintegrate, the
batch must be rejected.
• For Coated tablets:
1. To remove or dissolve the coat, immerse the tablet in distilled water for
5 min.
2. Put the tablet in the apparatus in water or 0.1 N HCl for 30min at 37oC
(according to the U.S.P).
3. If not disintegrated, put in intestinal fluid. If one or two tablets fail to
disintegrate, repeat on 12 tablets.
4. So 16 tablets from the 18 must completely disintegrate within the time.
5. If two or more tablets do not disintegrate within the time the batch is
rejected.
 Disintegration test
• For Enteric coated tablets:
1. Put the tablet in distilled water for five minutes to dissolve the coat.
2. Put in simulated gastric fluid for two hours (emptying time)
3. Put in phosphate buffer (PH 6.8) for one hour.
4. If one or two tablets fail to disintegrate repeat on 12 tablets.
5. So 16 tablets should disintegrate. If more than two tablets fail
to disintegrate, reject the batch.
 The disintegration
apparatus

A cylindrical disk of transparent plastic is

also used if specified in monograph.

Six tubes opened at the upper end and closed by a screen at the lower

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Content uniformity
This test is done to ensure that every tablet contains
the amount of drug substance intended with little
variation within a batch
Procedure In this test 30 tablets are randomly selected
for the sample and atleast 10 of them assayed
individually
9 of the 10 tablets must contain not less than 85% or
more than 115 % of labeled drug content. 10th tablet may
not contain less than 75% or more than 125% of labeled
content.
If this conditions are not meet the tablet remaining
from the 30 must be assayed individually and none may
fall outside 85 to 115 % .
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 Content of active ingredient
• Procedure:
• Perform the assay of 20 tablets as per monograph
• The result should lie within the range for the content of active
ingredient stated in the monograph.
• If small no. of tablets (min 5) are used then the limits specified in the
monograph may be relaxed to the extent indicated in the table.
Weight of medicament Subtract from the lower Add to the upper limit
in each tablet limit for sample of for sample of

15 10 05 15 10 05

0.12 g or less 0.2 0.7 1.6 0.3 0.8 1.8

>0.12 g &< 0.3 g 0.2 0.5 1.2 0.3 0.6 1.5

0.3 g or more 0.1 0.2 0.8 0.2 0.4 1.0

Weight variation
 The volumetric fill of the die cavity determines the weight of
the
compressed tablet .
 The weight of the tablet is the quantity of the granulation
that contains the labeled amount of the therapeutic
ingredient.
 After the tablet machine in operation the weights of the
tablets are routinely checked to ensure that proper tablet
weights are made.
 Procedure : •
 Take 20 tablets and ,measure the individual weights of each
tablets
 Take average weights of 20 tablets
 Compare the individual weight of tablets with avg weight.
 Not more than 2 tablets should deviate from avg weight by 23
IP standard for weight variation
Sr. No Average wt. of tablet(mg) Max. % difference
allowed
1 80 or Less 10%
2 80- 250 7.5%
3 More than 250 5%

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Dissolution test
Dissolution is performed to check the percentage release
from the dosage forms from the tablet.
When tablet disintegrate it breaks down into small
particles which offers a greater surface area to the
dissolving media and drug will dissolve.
• It is the solubilization of the drug or active moiety in
to the dissolution media.
• It is done for measuring the amount of time required for a
given percentage of the drug substance in a tablet to go into
solution under specified condition. 25
 Dissolution test
• Apparatus:
1. A cylindrical vessel (made up of glass or other transparent
material) having 1000 ml capacity, fitted with a lid having
four holes, one for shaft of stirrer, second for placing the
thermometer and remaining two for sample removal.
2. An electric motor
3. A cylindrical stainless steel basket made of wire with
aperture size of 425 µm
attached to the disc on the driving shaft.
4. Suitable device for withdrawal of sample.
 Dissolution test
• Method:
• Place 1000 ml of water into the vessel. Place the specified number of
tablets in the dry basket and set the apparatus. Start the motor and
adjust the temperature and rotation speed to 36.5◦c to 37.5◦c and
100 rpm or as given in monograph. Withdraw the sample after
specified time intervals. Filter and determine the amount of active
ingredient present in it by the method given in the monograph.
• Acceptance criteria:
1. S1= 6 tablets are taken Acceptable: If all of the tablets are not
less than Q ±5%
2. If S1 fails, S2=S1+6 tablets are taken Acceptable: If average of
12 tablets is ≥Q and no tablet is less than Q-15%
3. If S2 fails, S3= 12+12 tablets are taken Average of 24 ≥ Q% not
more than 2 tablets should be less than Q-15% and None
should be less than Q-25%
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Mainly used Dissolution apparatus(IP)
Dissolution apparatus I
( Basket method)

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Dissolution apparatus II
(Paddle type)

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Leak testing for Strips and Blister
packing
 Take the required number of strips / blisters as mentioned in annexure .
Check
the quality of strips/ blisters for any damages.
 Tie the collected strips / blisters with a rubber band.
 Ensure that all strips / blisters are dipped in water and close the lid.
 Connect opening of the desiccator to the vacuum pump.
 Apply a vacuum of 300 mm of Hg and close the knob of the desiccator.
 Keep the vacuum for 30sec.
 Release the vacuum by opening the knob of the desiccator slowly and open
the lid remove the strips / blisters.
 Wipe out the traces of water from the strips / blisters by using lint free
duster .
 Open the pocket of strips by using scissors to remove the tablets / capsules.
 Open the blisters manually.
 Check for any traces of water inside the strips / blisters.
 Number of tablets or capsules, which have become wet, should not be
more than 1% .
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 Comparison of Specifications and Parameters
Tests IP BP USP
Contenter uniformity 98- 102 % NS NS

Drug Content 90 – 110 % NS NS

Content uniformity 85 - 115 % 85 - 115 % 85 - 115 %

Weight uniformity <10% <10% <10%

Friability <1% <1% <1%
Disintegration test Disintegration time
Uncoated tab < 15 min < 15 min <15 min
Plain coated tab < 60 min < 60 min < 60 min
Enteric coated tab 3 hr NS NS
Dispersible tab 3 min 3 min NS
Effervescent tab < 3 min < 3 min NS
Orodispersible tab NS 3 min NS
Gastro resistant tab NS 3 hr NS
Dissolution test > 70% > 70% > 70%

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