In-process and Finished Product Quality Control tests for Tablets with limits according to IP, BP, and USP

1. IN-PROCESS AND
FINISHED
PRODECT
QUALITY
CONTROL TESTS
FOR TABLETS
Presented by-
SONALI PRADHAN
M Pharmacy-Quality Assurance,
Institute of Pharmacy
GITAM (Deemed to be University)

2. CONTENTS
 Introduction
 IPQC and FPQC tests of Tablets
1. Size and Shape
2. Colour and Odour
3. Unique identification markings
4. Moisture control of granules
5. Assay
6. Content uniformity
7. Weight variation
8. Thickness
9. Hardness
10.Friability
11.Disintegration test
12.Dissolution test
 References

3. INTRODUCTION
 In-Process Quality Control (IPQC)- Tests performed during production in order to
monitor and, if necessary, to adjust the process to ensure that the product conforms to its
specifications.
 Finished Product Quality Control (FPQC) - Tests which are performed when the
manufacturing process is completed in order to check qualitative and quantitative
characteristics along with test procedures and their acceptable limits by which the
finished product must comply throughout its valid shelf-life

4. IPQC & FPQC TESTS-
1. Size and Shape
The size and shape of the tablets helps in identification and should be according to need of the dose
requirement and can be dimensionally described and monitored.
2. Color and Odor
For ease identification some pharmaceutical companies use color and it is also helpful for consumer
acceptance. But it must be uniform within single tablet , from tablet to tablet and from batch to batch.
Some types of tablets such as ODT tablets, chewable tablets have an odor to make a pleasant taste and
improve patient acceptance.
3. Unique identification markings
Pharmaceutical companies often use some type of unique markings such as engraved with a symbol or letters
or printing on the tablet for rapid identification. The tablets may score in halves or quadrants to facilitate
breaking or to make the smaller dose. Intact and clear unique identification markings on tablets are
acceptable.

5. 4. Moisture content of granules
Moisture of granules are required in some cases for binding of tablets.
Granules should possess sufficient strength to withstand normal handling and mixing
processes without breaking down.
On the other hand, some size reduction during compaction into tablets is desirable to expose
the areas of clean surface necessary for optimum bonding to take place. So moisture content is
very important factor for producing good product.
5. Assay
This determines the strength and purity of the API in the product.

6. 6. Content Uniformity test
To evaluate a tablet potential for efficacy, the amount of drug per tablet needs to be monitored
from tablet to tablet and batch to batch.
For this test suitable analytical method is used to determine the contents of active substances.
Limit – IP/BP/USP
-10 tablets are taken randomly, each individual content should be between 85%-115% of
average content.
If 2-3 tablets values are outside the limits 85-115% of average value, and none outside 75-
125% , the repeat for 20 tablets.
Complies when 30 tablets NMT 3 of the individual values are outside the limits 85-115% of the
average values and none outside 75-125%

7. 7. Weight Variation
This test is performed to evaluate uniformity in weight of tablets because it will affect the
bioavailability and therapeutic activity of tablets.
It is desirable that every individual tablet in a batch is uniform in weight and the weight
variation if any is within the permissible limits as is given in the official pharmacopoeias of
each country. The test of uniformity of weight is carried out by collecting a sample of
tablets, normally 20, from a batch and determining their individual weights. The average
weight of the tablet is then calculated.
Weight Variation = [(WI − WA) /WA ]× 100
Where, WI = Individual tablet’s weight; WA = Average tablet’s weigh
Limits for weight variation
IP/BP Percentage Deviation
(%)
USP
80mg or less 10 130mg or less
>80mg and <250mg 7.5 >130mg and <325mg
250mg or more 5 325mg or more

8. 8. Thickness of tablet
The thickness of the tablet is the only dimensional variable related to the tablet compression
process. Generally, it is measure with a micrometer. The thickness should control within ±5%
variation of a standard value and must control for patient acceptance and make the tablet
packaging easier.
9. Hardness of tablets
The hardness of a tablet is indicative of its tensile strength and is measured in terms of
load/pressure required to crush it.
Hardness is measured by hardness tester-the Monsanto tester, the Pfizer tester, the Erweka
tester, the Schleuniger tester.
10 tablets are crushed and their hardness is measured and allowable range is between 4-6 kilo
Hardness of about 5 KiloPascals is considered to be minimum for uncoated tablets.

9. 10.Friability
A compressed and uncoated tablets strength and durability may be determined through the use
of friabilator mostly by Roche friabilator . For this test, a sample of 10 whole tablets
respectively are weighed, dedusted and placed in drum of friabilator where it is rotated for
100 times.
The tablets are then dedusted and reweighed.
The friability value is expressed in percentage, which is calculated by using the subsequent
formula: Friability = (Wi − Wf)/ Wi × 100
Where, Wi = Total initial mass of tablets; Wf = Total final mass of tablets.
The limit is given as follows
Maximum loss of weight
IP NMT 1%
BP NMT 1%
USP NMT 1%

10. 11. Disintegration Test
This test is to determine the act of breaking down of tablets into smaller particles or into
constituent elements within the prescribed time when placed in a liquid medium under the
described experimental conditions.
To assess the time of disintegration, a single tablet is positioned in every tube, and the basket
rack is placed in particular liquid medium at a temperature of 37 ± 2 °C (unless otherwise
specified in the individual monograph)
The tablets conform to the test if no any residue retains on 10-mesh screen in a specified time
frame. If present, they should be soft mass having no palpably firm core. If 1 or 2 tablets (out
of 6 tablets) not succeed to disintegrate then a trial is repeated on 12 extra tablets

11. Limits for disintegration time of tablets Acc. To USP
Types of tablets Medium Temp ( C) Time(Minutes)
Uncoated tablets Water / as
specified in the
individual
monograph
37 ± 2 as specified in
the individual
monograph
Coated tablets Water/ as
specified in the
individual
monograph
37 ± 2 as specified in
the individual
monograph
Delayed release/
Enteric coated
tablets
Simulated gastric
fluid
Simulated gastric
fluid
37 ± 2 No evidence of
disintegration
after 1 hour
Buccal tablets Water/ as
specified in the
individual
monograph
37 ± 2 After 4 hours
Sublingual
tablets
Water/ as
specified in the
individual
monograph
37 ± 2 as specified in
the individual
monograph

12. Limits acc. to IP and BP
Types of tablets Medium Temp (C) Time (Minutes)
Uncoated tablets water 37 ± 2 15
Coated tablets Water 37 ± 2 60
Film coated
tablets
Water 37 ± 2 30
Effervescent
tablets
200ml of non-
agitated water
20 ± 5 3
Enteric coated
tablets
0.1N HCl/ as
specified in
individual
monograph
Phosphate buffer
solution (pH 6.8)
37 ± 2
37 ± 2
No evidence of
disintegration
after 2 hours
60
Soluble tablets water 20 ± 5 3

13. 12. Dissolution test
This test evaluates the rate and extent that the tablet forms a solution under controlled
conditions.
Dissolution apparatus consists of cylindrical vessels with hemispherical bottom made up of
glass or inert transparent material; metallic shaft and cylindrical basket.
For the test 1 tablet is placed in vessel containing specified medium required at 37+_0.5C.
Operate the apparatus at specified rate, within the time interval samples are withdraw from zone
midway.
Sample analysis is performed using suitable assay method or specified in individual monograph.

14.  Limits- According to IP, BP, USP, JPand PhEur
D-specified amount of dissolved active substance , expressed in % of the labelled amount
Level Number of samples tested Acceptance criteria
S1 6 Each unit not less than
D*+5%
S2 6 Average of 12 units (S1+S2) is
equal to greater than D* and
no unit less than
D*-15%
S3 12 Average of 12 units
(S1+S2+S3) is equal to
greater than D* ; 2 units less
than
D*-15% and no unit less than
D*-25%

15. REFERENCES
1. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. 7th edition, Ghaziabad; 2007
2. British Pharmacopoeia Commission. British Pharmacopoeia, 12th edition, Stationery office, Great
Britain, 2013
3. United States Pharmacopoeia Convention. United States Pharmacopoeia 38-National Formulary 33,
Stationery Office, USA, 2010
4. L. Lachman- The Theory and Practice of Industrial Pharmacy, 3rd edition, 1986;296-300
5. Chavan Harish Chandra: Comparative Study of In-process and Finished Product Quality Control tests
for Tablets and Capsules According to Pharmacopoeias, Asian Journal of Pharmaceutical research and
Development. 2018;6(3):60-68

16. Thank you