This document provides information on quality control tests for tablet dosage forms as per the Indian Pharmacopoeia 2018. It discusses tests like uniformity of weight, uniformity of content, friability, disintegration, and dissolution. The uniformity of weight test ensures that tablets are of uniform weight by measuring the percentage deviation from the average weight. The uniformity of content test checks dosage uniformity by determining the active ingredient content in individual tablets. The friability test measures the physical strength of uncoated tablets. The disintegration test specifies the time required for tablets to disintegrate fully in a liquid medium, while the dissolution test determines the amount of active ingredient released over time in a specified liquid.

1. QUALITY CONTROL TESTS OF
TABLET DOSAGE FORM AS PER
INDIAN PARMACOPOEIA 2018
PREPARED BY
MS. SHITAL TRIVEDI
ASSISTANT PROFESSOR,
L.J.INSTITUTE OF PHARMACY
1

2. IP 2018 includes following quality control tests
to evaluate tablet.
1. UNIFORMITY OF WEIGHT ( WEIGHT VARIATION)
2. UNIFORMITY OF CONTENT
3. FRIABILITY TEST (APPLICABLE TO UNCOATED COMPRESSED
TABLETS)
4. DISINTEGRATION TEST
5. DISSOLUTION TEST
2

3. 1. UNIFORMITY OF WEIGHT
• Purpose of test: Uniform blend ensure the dosage uniformity.
• Method:
1. Select 20 tablets randomly.
2. Weigh individually all 20 tablets. Calculate the average
weight.
3. Calculate the % deviation of an individual tablet weight from
the average weight using following formula.
% Deviation from the average weight = (Individual tablet weight – Average tablet weight) * 100
Average tablet weight
(Or calculate the minimum and maximum deviation limit
from the average weight by rearranging the above formula
(Individual tablet weight – Average tablet weight) = % Deviation from the average weight * Average tablet weight)
100)
4. Interpret the result data based on the % deviation allowed
and acceptance limits. 3

4. PERCENTAGE DEVIATION ALLOWED AS PER IP 2018
Dosage form Average weight Percentage
deviation
Uncoated and film
coated tablets
80 mg or less ±10
More than 80 mg but
less than 250 mg
±7.5
250 mg or more ±5
4
ACCEPTANCE LIMITS
Product complies the test if not more than two of the individual
weights deviate from the average weight by more than the
percentage shown in the above table and none deviates by more
than twice that percentage.

5. Example:
For the product under test, desired weight of each tablet is 500
mg, containing 300 mg API-Active Pharmaceutical Ingredient.
5
• Three possible cases of Result data:-
Result Data 1 Result Data 2 Result Data 3
Tablet Weight (mg)
% Deviation from the
average weight Tablet Weight (mg)
% Deviation from the
average weight Tablet Weight (mg)
% Deviation from
the average weight
1 506 0.6 1 506 0.6 1 506 0.6
2 510 1.4 2 510 1.4 2 510 1.4
3 505 0.4 3 505 0.4 3 505 0.4
4 506 0.6 4 506 0.6 4 506 0.6
5 470 -6.6 5 470 -6.6 5 498 -1.0
6 509 1.2 6 509 1.2 6 509 1.2
7 491 -2.4 7 491 -2.4 7 491 -2.4
8 525 4.4 8 525 4.4 8 525 4.4
9 515 2.4 9 515 2.4 9 515 2.4
10 505 0.4 10 505 0.4 10 505 0.4
11 506 0.6 11 506 0.6 11 506 0.6
12 507 0.8 12 507 0.8 12 507 0.8
13 500 -0.6 13 500 -0.6 13 500 -0.6
14 540 7.4 14 540 7.4 14 518 3.0
15
500
-0.6 15
500
-0.6 15
500
-0.6
16 502 -0.2 16 502 -0.2 16 560 11.3
17 515 2.4 17 515 2.4 17 515 2.4
18 495 -1.6 18 535 6.4 18 495 -1.6
19 495 -1.6 19 495 -1.6 19 495 -1.6
20 500 -0.6 20 500 -0.6 20 500 -0.6
Average weight 505.1 Average weight 507.1 Average weight 508.3
Interpretation: Complies Interpretation: Fail Interpretation: Fail
Case 1: Average weight is 505 mg, % deviation from average weight allowed is
±5%. (i.e. minimum weight 479.75 mg to maximum weight 530.25 mg).
For ±10% limit is 454.5 mg to 555.5 mg. Formula for % Dev. = (Ind.-avg) * 100/avg.

6. 2. UNIFORMITY OF CONTENT
6
(Note: When the average weight is equal to or below 40 mg, then
product must be submitted for the uniformity of content test.
• Purpose of test: To ensure dosage uniformity.
• Method: Test is based on the assay of individual content of
active substance(s).
1. Select 30 tablets randomly.
(Initial testing on 10 tablets. Preserve 20 tablets for the further
testing if required.)
2. Refer IP monograph specific to the active substance present in
selected tablet product for assay method or select any other
suitable analytical method to determine content of active
ingredient.
3. Select 10 tablets randomly from 30 tablets.

7. Method….
4. Determine the content of active ingredient(s) in each of 10
tablets using selected assay method. Calculate the average
content.
5. Calculate the % deviation of an individual tablet content
from the average content using following formula.
% API content with reference to average content= (Individual content * 100 )/ Average content
6. Interpret the result data based on acceptance limits.
7. If product fails to comply with the test at this stage, assay all
remaining 20 tablets and Interpret the result data.
7

8. ACCEPTANCE LIMITS
8
The preparation/product complies with the test if each individual
content is 85 to 115 percent of average content. No further
testing is required.
• If one individual content is outside the limits of 85 to 115
percent of the average content but within the limits of 75 to 125
percent, repeat the determination using another 20 tablets.
• The product complies with the test if not more than one of the
individual contents of the total sample of 30 tablets is outside
the limit of 85 to 115 percent of the average content and none
is outside the limits of 75 to 125 percent of the average content.
The product fails to comply with the test if more than one
individual content is outside the limit of 85 to 115 percent of
the average content OR if one individual content is outside the
limits of 75 to 125 percent of the average content.

9. Example:
For product under test, the desired weight of each tablet is 30 mg
which contains 10 mg API-Active Pharmaceutical Ingredient.
9
• Interpretation of 4 possible result data:
Assay Result Data 1 Assay Result Data 2
Tablet API content(mg)
% API content
with reference
to average
content
1 10 109.5
2 9 98.6
3 8 87.6
4 9 98.6
5 10 109.5
6 9.5 104.1
7 9.2 100.8
8 9.3 101.9
9 8 87.6
10 8.5 93.1
Average
content of
10 tablets
9.05
Interpretati
on
Product
complies the
test.
Tablet
API
content(
mg)
% API
content
with
reference
to average
content of
9.15
Tablet
API
content(
mg)
% API
content
with
reference
to average
content of
9.07 mg
Tablet
API
content(
mg)
% API
content with
reference to
average
content of
9.07 mg
% API
content of
1st 10 tab.
with
reference
to average
content of
9.07 mg
1 10 109.5 11 9.5 104.7409 21 9.8 108.0485 110.2536
2 9 98.6 12 9 99.22822 22 9 99.22822 99.22822
3 8 87.6 13 8 88.20287 23 8 88.20287 88.20287
4 9 98.6 14 8.9 98.12569 24 9 99.22822 99.22822
5 11 120.5 15 10 110.2536 25 10.1 111.3561 121.2789
6 9.5 104.1 16 9.5 104.7409 26 9.5 104.7409 104.7409
7 9.2 100.8 17 9.2 101.4333 27 9.2 101.4333 101.4333
8 9.3 101.9 18 9.4 103.6384 28 9.3 102.5358 102.5358
9 8 87.6 19 8 88.20287 29 8 88.20287 88.20287
10 8.5 93.1 20 8.5 93.71555 30 8.8 97.02315 93.71555
Average
content
of 10
tablets
9.15
Average
content
of 30
tablets
9.07
Interpret
ation
Product
compli
es the
test.

10. 10
Assay Result Data 3 Assay Result Data 4
Tablet API content(mg)
% API content
with reference to
average content
1 10 109.5
2 9 98.6
3 8 87.6
4 9 98.6
5 11 120.5
6 9.5 104.1
7 9.2 100.8
8 10.8 118.3
9 8 87.6
10 8.5 93.1
Average content
of 10 tablets
9.3
Interptretation
Product fails
the test
--------------*--------------

11. 3. FRIABILITY OF UNCOATED TABLETS
• Purpose of test: To determine the physical strength of
tablets.(To resist the damage during further processing,
packaging and handling during transportation).
• Apparatus required: As per the design specification given in IP.
• It consists of a drum (with curved projection inside it and
removable lid) which is attached to the horizontal axis of a device
that rotates at 25 ± 1 rpm.
• It should be ensured that with every turn of the drum the tablets
roll or slide and fall onto the drum wall or onto each other. (If the
size or shape of the tablet causes irregular tumbling, adjust the
drum base so that it forms an angle of about 100 with horizontal
platform.)

12. Method: Friability testing.
1. Number of tablets to be taken depend on the average weight of
the tablets.
• Take a sample of 10 whole tablets if an average weight of
tablets is more than 0.65 g.
• Take number of whole tablets corresponding to about 6.5 g if an
average weight of tablets is equal or less than 0.65 g,
1. Dedust the selected tablets carefully and Weigh accurately.
2. Place the tablets in the drum and rotate it 100 times (4 minutes
at 25 RPM).
3. Remove the tablets from the drum after completion of the
required rotations, remove any loose dust from them and weigh
them accurately.
4. Find out the percentage loss in weight using following formula:
Weight of tablets before test- weight of intact tablets after test * 100
Weight of tablets before test 12

13. Method…
( Note: The test is run only once unless the results are difficult to
interpret or the weight loss is greater than the targeted value,
in which case, the test is repeated twice and the mean of the
three tests is determined.)
6. Interpret the result data based on acceptance limit.
ACCEPTANCE LIMIT
• A maximum loss of weight ( from a single test or from the mean of
the three tests) not greater than 1.0 % is acceptable for most
tablets.
for e.g. Average weight of tablets is 0.70 g. Perform test on 10
tablets. Product complies the test as % loss in weight is 0.71 which
is not more than 1.0%
% loss in weight = Weight of tablets before test (7.000 g)- weight of intact tablets after test (6.950 g) * 100
Weight of tablets before test (7.000 g)
• If cracked, chipped or broken tablets are present in the sample after tumbling,
it’s obvious that the sample fails the test. -------------*---------------- 13

14. DISINTEGRATION TEST & DISSOLUTION
TEST OF TABLET/CAPSULE DOSAGE FORM
AS PER INDIAN PARMACOPOEIA 2018
14

15. DISINTEGRATION TEST
For Solid dosage units: Tablets/Capsules.
• This test determines whether tablets/capsules
disintegrate within prescribed time in a given liquid
medium under the prescribed experimental conditions.
Disintegration increases surface area of drug particles to
get dissolved at higher rate.
• As per IP…
Disintegration of is defined as that state in which no
residue of the dosage unit under test remains on the
screen of the apparatus or, if a residue remains, it
consists of fragments of insoluble coating of the tablets
or of capsule shells or a soft mass with no solid core.

16. Apparatus required: For Disintegration test
• As per the design specification given in IP.
• Apparatus A and Apparatus B
• For dosage unit with length of 18 mm or less- Apparatus A and for larger dosage units
– Apparatus B.
Apparatus A:
It consists of
• A basket-rack assembly ( 6 cylindrical tubes and
lower end of each tube is attached with woven
stainless steel wire screen of 2.0 ± 0.2 mm mesh
aperture size),
• 1-litre beaker,
• Thermostatic arrangement for heating the fluid
(for maintaining the temperature 37 ± 20C) and
• A mechanical device for raising and lowering the
basket in the immersion fluid at a constant
frequency rate(between 29 and 32 cycles per
minute through a distance of 55 ±2 mm)
• Disc.

17. 17
METHOD:
1. The volume of immersion liquid is adjusted in such that the
wire mesh is at least 15 mm below the surface of the liquid at
its highest Point during upward movement and is at least 25
mm above the bottom of the beaker at its lowest point during
downward movement.
2. Introduce 1 dosage unit into each tube and, if directed in the
general monograph, add a disc to each tube.
3. Suspend the assembly in the beaker containing the specified
liquid and operate the apparatus for the specified time.
4. Remove the assembly from the liquid. Observe the
disintegration of unit.

18. ACCEPTANCE CRITERIA
⮚ Tablets or capsules pass the test if all 6 of them have disintegrated.
⮚ If 1 or 2 tablets/capsules fail to disintegrate, repeat the test on 12
additional tablets/capsules; and now 16 of the total 18
tablets/capsules tested must disintegrate for the product to comply
the test.
⮚ If the tablets/capsules adhere to the disc and the preparation fails
to comply, repeat the test omitting the disc. The preparation
complies the test if all the tablets/capsules in the repeat test
disintegrate.
18
Type of Tablet/Capsule Disintegration time ( General monograph)
Uncoated conventional Tablet Within 15 minutes in water at 15–25° C.
Dispersible & Soluble Tablet Within 3 minutes in water at 15–25° C.
Effervescent Tablets Within 5 minutes in water at 15–25° C.
Sugar coated Tablets Within 60 minutes in water, if not repeat test in 0.1 M Hydrochloric acid.
Film coated Tablets Within 30 minutes
Enteric coated
Tablets/capsules
2 hrs(in 0.1 M Hydrochloric acid) and 60 minutes (in phosphate buffer
solution, pH 6.8(with added pancreatin for capsules).
Hard gelatin/Soft gelatin
Capsules
30 minutes in water.

19. DISSOLUTION TEST
• This test is designed to determine compliance with the
dissolution requirements for solid, semisolid &
suspension dosage forms
• Importance: As Q.C test, to check batch to batch
variation, as Biowaiver for the product approval under
certain conditions.
• Apparatus: As per the design specification given in IP.
• IP specifies 4 types of dissolution apparatus.
• Type 1 Paddle apparatus (USP Type 2 )
• Type 2 Basket apparatus ( USP Type 1)
• Type 3 Reciprocating cylinder
• Type 4 Flow-Through cell

20. IP Type 1 Dissolution Apparatus
Paddle Apparatus
20
IP Type 2 Dissolution
Apparatus
Basket Apparatus

21. METHOD:
For conventional- release tablets/capsules(Paddle/Basket apparatus)
21
Dissolution test is conducted at 3 stages. Stage 1 includes testing on total
6 dosage units.
1. Place the stated volume (as per the monograph) of the dissolution
medium (900 ml if not specified), free from dissolved air, into the each of
the 6 vessels of the apparatus. (If buffered solution is used as dissolution
medium, then pH of the solution should be within 0.05 units of the
specified pH).
2. Assemble the apparatus and warm the dissolution medium to 37 ± 0.50C.
3. Unless otherwise stated, introduce 1 tablet/capsule in each of the 6
vessels simultaneously and in a reproducible way.
4. Allow the tablet or capsule to sink to the bottom of the vessel prior to the
rotation of the paddle (use stainless steel sinkers for floating
tablets/capsules).
(When apparatus 2 to be used, place the tablet/capsule in a dry basket at
the beginning of each test. Lower the basket into position before rotation).

22. ………METHOD
5. Operate the apparatus immediately at the speed of rotation specified in
the individual monograph (Or 50 RPM if not specified).
6. Withdraw sample within the time interval specified or at each of the
times stated. (Sample should be withdrawn from a zone midway
between the surface of the dissolution medium and the top of the
rotating blade, not less than 10 mm from the wall of the vessel. Sample
should be withdrawn from the same zone either manually or
automatically at each sampling time point).
7. If multi time point sampling, replace the volume of sample withdrawn by
adding an equal volume of dissolution medium to the dissolution vessel.
8. If required, process the sample taken from dissolution vessel for
filtration, dilution, stirring and special storage conditions.
9. Perform the analysis as directed in the individual monograph.
10. Repeat the whole operation five times i.e. for all other 5 units.
11. For each of the tablet/capsule tested, calculate the amount of dissolved
API in solution as a percentage of the stated amount.
22

23. ………METHOD
12. Refer the acceptance criteria for conventional-release dosage forms.
13. Continue dissolution testing on additional 6 dosage units i.e. stage 2 and
then after on additional 12 dosage units i.e. stage 3 based on the result
data. Interpret the data based on acceptance criteria.
❖ For hard/soft gelatin capsules & gelatin coated tablets that don’t
conform to the dissolution specification, repeat the test by adding
specified amount of purified pepsin into dissolution
medium(water/specified medium with pH less than 6.8). For medium
with pH 6.8 or more, add specified amount of protease.
❖ (Note: When monograph specify a single time sampling, the test may be
concluded in a shorter period if the product complies the dissolution
requirement).
❖ When capsule shells interfere with the analysis, remove the contents of
not less than 6 capsules as completely as possible, and dissolve the
empty capsule sells in the specified volume of dissolution medium.
Perform analysis. Make Any necessary correction. Correction factor
should not be more tan 25 % of the stated amount)
23

24. ACCEPTANCE CRITERIA
FOR CONVENTIONAL-RELEASE DOSAGE FORMS
24
Level Number tested Acceptance Criteria
S1 6 Each unit is not less than D* + 5 per cent**
S2 6 Average of 12 units (S1+S2) is equal to or greater than D,
and no unit is less than D-15 percent**.
S3 12 Average of 24 units (S1 +S2+ S3) is equal to or greater than
D, not more than 2 units are less than D-15 Percent** and
no unit is less than D-25 percent**
*D is the amount of dissolved active ingredient specified in the individual monograph,
expressed as a percentage of the labeled content.
**Percentages of the labeled content.
Note: If one or more tablets within range of D-15 % to D+5 %
OR
not more than 2 tablets less than D-15 % but not less than D-25 % at S1
then eligible for S2 and S3 evaluation.

25. 25
Monograph indicates for dissolution:- Dissolution medium:0.1 N Hydrochloric acid, 900
ml, Paddle apparatus at 50 RPM, Assay method: UV spectrophotometry, % Dissolution
required: Not less than 80 % of the labeled amount of Methyldopa dissolved in 20
minutes. In this case D value is 80 %, sampling time at 20 minutes.
Labeled amount is 250 mg. D value(80%) of labeled amount is 200 mg. 5% of labeled
amount is 12.5 mg. D-15 % of labeled amount is 162.5 mg. D-25 % of labeled amount is
137.5 mg.
As per the acceptance criteria at S1, each unit/tablet must not less than D* + 5 per
cent** i.e. not less than 80 +5 = 85 % of the 250 mg. i.e. not less than 212.5 mg.
At S2, average of 12 units (S1+S2) is equal to or greater than D, and no unit is less than
D-15 percent** i.e. average of 12 must be equals to or greater than 200 mg., and no
unit be less than 162.5 mg.
At S3, average of 24 units (S1 +S2+ S3) is equal to or greater than D, not more than 2
units are less than D-15 Percent** and no unit is less than D-25 percent**i.e. average
of 24 must be equals to or greater than 200 mg., not more than 2 units must be less
than 162.5 mg and no unit must less than 137.5 mg.
Example: Methyldopa film coated conventional release
tablet containing 250 mg methyldopa.

26. Interpretation of 2 probable result data:
Dissolution data 1 Dissolution data 2
Stage 1 Stage 2 Stage 3
26
Product complies the
test at stage 3 criteria
Average of 12 tablets is >200mg
mg, but 1 tablet is less than
162.5 mg. Product fails to
comply Stage 2.
-------------------------------------------------------------
% API
dissolved
96
98
94
99.2
99.6
99.2
All units are
grater than
85 %

27. 27
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