Quality Control Tests For Tablets and Capsules(QC)

QUALITY CONTROL TESTSQUALITY CONTROL TESTS
FOR TABLETS ANDFOR TABLETS AND
CAPSULESCAPSULES
Presented by:Presented by:

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

Official Standards as per B.P.Official Standards as per B.P.
/I.P./ U.S.P./I.P./ U.S.P.
COMPARISON OF DIFFERENTCOMPARISON OF DIFFERENT
PHARMACOPOEIAL QUALITY CONTROLPHARMACOPOEIAL QUALITY CONTROL
TESTSTESTS
BRITISH PHARMACOPOEIABRITISH PHARMACOPOEIA
FOR ALL TABLETS:FOR ALL TABLETS:
 Content of active ingredientsContent of active ingredients
 DisintegrationDisintegration
 Uniformity of contentUniformity of content
 LabelingLabeling

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

Gastro resistant tablet:Gastro resistant tablet:
Modified release tablet:Modified release tablet:
-Uniformity of weight.-Uniformity of weight.
Dispersible tablet:Dispersible tablet:
-Uniformity of dispersion-Uniformity of dispersion

INDIAN PHARMACOPOEIAINDIAN PHARMACOPOEIA
Uncoated tablet:Uncoated tablet:
-Uniformity of container content-Uniformity of container content
-Content of active ingredient-Content of active ingredient
-Uniformity of content-Uniformity of content
Enteric coated tablet:Enteric coated tablet:

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

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

Official and unofficial tests:Official and unofficial tests:
 Official Tests:Official Tests:
Weight variation, disintegration,Weight variation, disintegration,
dissolution, drug content.dissolution, drug content.
 Non-Official Tests:Non-Official Tests:
Hardness, friability.Hardness, friability.

I-I- Non official tests:Non official tests:
HardnessHardness (crushing strength):(crushing strength):
It is the load required to crush the tablet whenIt is the load required to crush the tablet when
placed on its edgeplaced on its edge..
Why do we measure hardness?Why do we measure hardness?
 To determine the need for pressureTo determine the need for pressure
adjustments on the tableting machine.adjustments on the tableting machine.
 Hardness can affect the disintegration. SoHardness can affect the disintegration. So
if the tablet is too hard, it may notif the tablet is too hard, it may not
disintegrate in the required period of time.disintegrate in the required period of time.
And if the tablet is too soft, it will notAnd if the tablet is too soft, it will not
withstand the handling during subsequentwithstand the handling during subsequent

processing such as coating orprocessing such as coating or
packagingpackaging..
>In general, if the tablet hardness is too>In general, if the tablet hardness is too
high, we first check its disintegrationhigh, we first check its disintegration
before rejecting the patch. And if thebefore rejecting the patch. And if the
disintegration is within limit, we acceptdisintegration is within limit, we accept
the patch.the patch.
>If H. is high + disintegration is within time>If H. is high + disintegration is within time
è accept the batch.è accept the batch.

Factors Affecting the Hardness:Factors Affecting the Hardness:
 Compression of the tablet andCompression of the tablet and
compressive force.compressive force.
 Amount of binder. (More binder à moreAmount of binder. (More binder à more
hardness)hardness)
 Method of granulation in preparing theMethod of granulation in preparing the
tablet (wet method gives more hardnesstablet (wet method gives more hardness
than direct method, Slugging method givesthan direct method, Slugging method gives
the best hardness).the best hardness).
 Limits:Limits:
5 kilograms minimum and 8 kilograms5 kilograms minimum and 8 kilograms
maximum.maximum.

>Make hardness test on 5 tablets and then>Make hardness test on 5 tablets and then
take the average hardness.take the average hardness.
 FriabilityFriability::
It is the tendency of tablets to powder,It is the tendency of tablets to powder,
chip, or fragment and this can affect thechip, or fragment and this can affect the
elegance appearance, consumerelegance appearance, consumer
acceptance of the tablet, and also add toacceptance of the tablet, and also add to
tablet’s weight variation or contenttablet’s weight variation or content
uniformity problems.uniformity problems.

 Friability is a property that is related toFriability is a property that is related to
the hardness of the tablet.the hardness of the tablet.
 An instrument called friabilator is used toAn instrument called friabilator is used to
evaluate the ability of the tablet toevaluate the ability of the tablet to
withstand abrasion in packaging,withstand abrasion in packaging,
handling, and shipping.handling, and shipping.

Procedure:Procedure:
1. Weigh 20 tab altogether = W11. Weigh 20 tab altogether = W1
2. Put these tablets in the friabilator and adjust the2. Put these tablets in the friabilator and adjust the
instrument at 100 rpm (i.e. = 25 rpm for 4 min)instrument at 100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones) = W23. Weigh the 20 tablets (only the intact ones) = W2
4. Friability (% loss) =4. Friability (% loss) =
It must be less than or equal to1% but if more weIt must be less than or equal to1% but if more we
do not reject the tablets as this test is non-do not reject the tablets as this test is non-
official.official.
 Perform this test using 20 tablets that were usedPerform this test using 20 tablets that were used
first in the weight variation testfirst in the weight variation test

II-II- Official Tests:Official Tests:
Disintegration:Disintegration:
It is the time required for the tablet to breakIt is the time required for the tablet to break
into particles, the disintegration test is ainto particles, the disintegration test is a
measure only of the time required under ameasure only of the time required under a
given set of conditions for a group ofgiven set of conditions for a group of
tablets to disintegrate into particles.tablets to disintegrate into particles.

 Liquids used inLiquids used in
disintegrationdisintegration
 Water,Water,
 simulated gastric fluidsimulated gastric fluid
(PH = 1.2 HCl),(PH = 1.2 HCl),
 or Simulated intestinalor Simulated intestinal
fluid (PH = 7.5,fluid (PH = 7.5,
KH2PO4 (phosphateKH2PO4 (phosphate
buffer) + pencreatinbuffer) + pencreatin
enzyme +NaOH)enzyme +NaOH)

 Limits:Limits:
For Uncoated tablets:For Uncoated tablets:
MediumMedium TemperTemper
atureature
TimeTime
limitlimit
According toAccording to
U.S.P.U.S.P.
SimulatedSimulated
gastricgastric
fluidfluid
37oC37oC NotNot
exceedexceed
30min30min
According toAccording to
B.P.B.P.
waterwater 37oC37oC NotNot
exceedexceed
15min15min

U.S.P. method for uncoated tablets:U.S.P. method for uncoated tablets:
 Start the disintegration test on 6 tablets.Start the disintegration test on 6 tablets.
 If one or two tablets from the 6 tablets failIf one or two tablets from the 6 tablets fail
disintegrate completely within 30mindisintegrate completely within 30min
repeat the same test on another 12 tablet.repeat the same test on another 12 tablet.
(i.e. the whole test will consume 18(i.e. the whole test will consume 18
tablets).tablets).
 Not less then 16 tablets disintegrateNot less then 16 tablets disintegrate
completely within the timecompletely within the time
 if more then two tablets (from the 18) failif more then two tablets (from the 18) fail
to disintegrate, the batch must be rejected.to disintegrate, the batch must be rejected.

For Coated tablets:For Coated tablets:
 1. To remove or dissolve the coat, immerse1. To remove or dissolve the coat, immerse
the tablet in distilled water for 5min.the tablet in distilled water for 5min.
 Put the tablet in the apparatus in water orPut the tablet in the apparatus in water or
HCL for 30min at 37oC (according to theHCL for 30min at 37oC (according to the
U.S.P). If not disintegrated, put in intestinalU.S.P). If not disintegrated, put in intestinal
fluid.fluid.
>If one or two tablets fail to disintegrate,>If one or two tablets fail to disintegrate,
repeat on 12 tablets. So 16 tablets from therepeat on 12 tablets. So 16 tablets from the
18 must completely disintegrate within the18 must completely disintegrate within the
time >>if two or more not disintegrated thetime >>if two or more not disintegrated the
batch is rejected.batch is rejected.

U.S.P. Method for Enteric coated tablets:U.S.P. Method for Enteric coated tablets:
 1. Put in distilled water for five minutes to1. Put in distilled water for five minutes to
dissolve the coat.dissolve the coat.
 2. Then put in simulated gastric fluid (0.1M2. Then put in simulated gastric fluid (0.1M
HCL) for one hour.HCL) for one hour.
 3. Then put in simulated intestinal fluid for3. Then put in simulated intestinal fluid for
two hours.two hours.
 If one or two tablets fail to disintegrate,If one or two tablets fail to disintegrate,
repeat this test on another 12 tablets. So 16repeat this test on another 12 tablets. So 16
tablets from 18 should completelytablets from 18 should completely
disintegrate. If more than two fail todisintegrate. If more than two fail to
disintegrate the patch must be rejected.disintegrate the patch must be rejected.

B.P. method for Enteric coated tablets:B.P. method for Enteric coated tablets:
 1. Put in distilled water for five minutes to1. Put in distilled water for five minutes to
dissolve the coat.dissolve the coat.
 2. Put in simulated gastric fluid for two2. Put in simulated gastric fluid for two
hours (emptying time).hours (emptying time).
 3. Put in phosphate buffer (PH 6.8) for one3. Put in phosphate buffer (PH 6.8) for one
hour.hour.
 4. If one or two tablets fail to disintegrate4. If one or two tablets fail to disintegrate
repeat on 12 tablets. So 16 tablets shouldrepeat on 12 tablets. So 16 tablets should
disintegrate. If more than two tables fail todisintegrate. If more than two tables fail to
disintegrate reject the batch.disintegrate reject the batch.

Weight Variation (uniformity of weight) ofWeight Variation (uniformity of weight) of
tablets:tablets:
1.1. Weigh 20 tablet selected at random,Weigh 20 tablet selected at random,
each one individuallyeach one individually . X1, X2, X3… Xz. X1, X2, X3… Xz
2.2. Determine the average weight. X=Determine the average weight. X=
(X1+X2 +X3+…+ Xz)/20(X1+X2 +X3+…+ Xz)/20
 Limits according to U.S.PLimits according to U.S.P
 · Weight of tablet 130 mg or less then· Weight of tablet 130 mg or less then
%error = ±10%%error = ±10%
 · Weight of tablet 130-324 mg then· Weight of tablet 130-324 mg then
%error = ±7.5%%error = ±7.5%
 · Weight of tablet 324 mg or more then· Weight of tablet 324 mg or more then
%error = ±5%%error = ±5%

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

Quality control tests of capsulesQuality control tests of capsules
B.P. method for disintegration of capsules:B.P. method for disintegration of capsules:
 Introduce one capsule into each tube and suspend theIntroduce one capsule into each tube and suspend the
apparatus in a beaker containing 600 ml water @apparatus in a beaker containing 600 ml water @
37oC.37oC.
 If hard capsules float on the surface of the water, theIf hard capsules float on the surface of the water, the
discs may be added.discs may be added.
 Operate the apparatus for 30 minutes; remove theOperate the apparatus for 30 minutes; remove the
assembly from the liquid.assembly from the liquid.
>The capsules pass the test if>The capsules pass the test if
 No residue remains on the screen of the apparatus or,No residue remains on the screen of the apparatus or,
 If a residue remains, it consists of fragments of shellIf a residue remains, it consists of fragments of shell
or,

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

Average Weight ofAverage Weight of
CapsuleCapsule
Percentage DeviationPercentage Deviation
Less than 300 mgLess than 300 mg 1010
300 mg or more300 mg or more 7.57.5

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