QUALITY CONTROL TESTS

FOR TABLETS AND

CAPSULES

Quality Control of Tablets

General Appearance:
-Size, shape, and thickness:
This is important to facilitate packaging
and to decide which tablet compressing
machine to use.
-Organoleptic properties:
which include color and odor of the
tablets.

Official Standards as per B.P.

/I.P./ U.S.P.
COMPARISON OF DIFFERENT
PHARMACOPOEIAL QUALITY CONTROL
TESTS
BRITISH PHARMACOPOEIA
FOR ALL TABLETS:
Content of active ingredients
Disintegration
Uniformity of content
Labeling

Uncoated tablet:
-Disintegration test
-Uniformity of weight
Effervescent tablet:
-Disintegration test
-Uniformity of weight
Coated tablet:
-Disintegration test
-Uniformity of weight

Gastro resistant tablet:

-Disintegration test

Modified release tablet:

-Uniformity of weight.
Dispersible tablet:
-Disintegration test
-Uniformity of dispersion
-Uniformity of weight

INDIAN PHARMACOPOEIA
Uncoated tablet:
-Uniformity of container content
-Content of active ingredient
-Uniformity of weight
-Uniformity of content
-Disintegration test
Enteric coated tablet:
-Disintegration test

Dispersible tablet:
-Uniformity of dispersion
-Disintegration
Soluble tablet:
-Disintegration test
Effervescent tablet:
-Disintegration/ Dissolution / Dispersion
test

UNITED STATES PHARMACOPOEIA

Physical tests applicable to tablet formulation:
-Bulk density /Tapped density of powder
-Powder fineness
-Loss on drying
-Disintegration test
-Tablet friability
-Dissolution test
-Drug release testing
-Uniformity of dosage form
-Container permeation test
-Labeling of inactive ingredients

Official and unofficial tests:

Official Tests:
Weight variation, disintegration,
dissolution, drug content.
Non-Official Tests:
Hardness, friability.

I- Non official tests:

Hardness (crushing strength):
It is the load required to crush the tablet when
placed on its edge.

Why do we measure hardness?

To 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 H. is high + disintegration is within time
accept the batch.

Factors Affecting the Hardness:

Compression of the tablet and
compressive force.
Amount of binder. (More binder more
hardness)
Method of granulation in preparing the
tablet (wet method gives more hardness
than direct method, Slugging method gives
the best hardness).
Limits:
5 kilograms minimum and 8 kilograms
maximum.

>Make hardness test on 5 tablets and then

take the average hardness.
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
tablets 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.

Procedure:
1. Weigh 20 tab altogether = W1
2. Put these tablets in the friabilator and adjust the
instrument at 100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones) = W2
4. Friability (% loss) =
It must be less than or equal to1% but if more we
do not reject the tablets as this test is non-official.
Perform this test using 20 tablets that were used
first in the weight variation test

II- Official Tests:

Disintegration:
It is the time required for the tablet to break
into particles, 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.

Liquids used in
disintegration
Water,
simulated gastric fluid
(PH = 1.2 HCl),
or Simulated intestinal
fluid (PH = 7.5,
KH2PO4 (phosphate
buffer) + pencreatin
enzyme +NaOH)

Limits:
For Uncoated tablets:

Medium

Temper Time
ature
limit
According to Simulated 37oC
Not
U.S.P.
gastric
exceed
fluid
30min
According to water
37oC
Not
B.P.
exceed
15min

U.S.P. method for uncoated tablets:

Start the disintegration test on 6 tablets.
If one or two tablets from the 6 tablets fail
disintegrate completely within 30min
repeat the same test on another 12 tablet.
(i.e. the whole test will consume 18
tablets).
Not less then 16 tablets disintegrate
completely within the time
if more then 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 5min.
Put the tablet in the apparatus in water or
HCL for 30min at 37oC (according to the
U.S.P). If not disintegrated, put in intestinal
fluid.
>If one or two tablets fail to disintegrate,
repeat on 12 tablets. So 16 tablets from the
18 must completely disintegrate within the
time >>if two or more not disintegrated the
batch is rejected.

U.S.P. Method for Enteric coated tablets:

1. Put in distilled water for five minutes to
dissolve the coat.
2. Then put in simulated gastric fluid (0.1M
HCL) for one hour.
3. Then put in simulated intestinal fluid 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 patch must be rejected.

B.P. method for Enteric coated tablets:

1. Put 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. So 16 tablets should
disintegrate. If more than two tables fail to
disintegrate reject the batch.

Weight Variation (uniformity of weight) of

tablets:
1. Weigh 20 tablet selected at random,
each one individually . X1, X2, X3 Xz
2. Determine the average weight. X=
(X1+X2 +X3++ Xz)/20
Limits according to U.S.P
Weight of tablet 130 mg or less then
%error = 10%
Weight of tablet 130-324 mg then
%error = 7.5%
Weight of tablet 324 mg or more then
%error = 5%

Limit:
Upper limit = average weight + (average
weight * %error)
Lower limit = average weight - (average
weight * %error)
The individual weights are compared with
the upper and lower limits.
>>Not more than two of the tablets differ from
the average weight by more than the %
error listed, and no tablet differs by more
than double that percentage.

Quality control tests of capsules

B.P. method for disintegration of capsules:

Introduce one capsule into each tube and suspend the

apparatus in a beaker containing 600 ml water @
37oC.
If hard capsules float on the surface of the water, the
discs may be added.
Operate the apparatus for 30 minutes; remove the
assembly from the liquid.

>The capsules pass the test if

No residue remains on the screen of the apparatus or,
If a residue remains, it consists of fragments of shell
or,

Uniformity of Weight of capsules:

It is to be done on 20 capsules.
Limit:
Not more than two of the individual weights
deviate from the average weight by more
than the percentage deviation shown in the
table, and none deviates by more than
twice that percentage.

Average Weight of
Capsule

Percentage Deviation

Less than 300 mg

10

300 mg or more

7.5