Ipqc for tablets

2. Contents
Introduction
Importance of IPQC
General IPQC tests
IPQC tests for tablets
Documentation

14. IPQC Tests For Tablets:
Hardness
Friability
Thickness
Disintegration
Weight variation
Content uniformity
Dissolution
Leakage testing for strip and blister packaging

15. 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 è accept the batch

16. Factors Affecting the 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:
5 kilograms minimum and 8 kilograms maximum.
>Make hardness test on 5 tablets and then take the average
hardness
Some of devices used to test tablet hardness are :
1. Monsanto tester
2. Strong-cobb tester
3. Pfizer tester
4. Erwica tester

17. • MONSANTO TESTER
• PFIZER TESTER

18. 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.
• Commonly used friabilator in industries is Roche Friabilator

19. 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 = W2
4. Friability (% loss) =
It must be less than or equal to1%.

20. THICKNESS TEST:
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

21. 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.

22. DISINTEGRATION TEST
The disintegration USP device uses 6 glass tubes that are 3
inches long open at the top and held against a 10mesh screen
at the bottom end of the basket rack assembly.
Frequency of basket is 28-32 cycles/min . The test is done
on 6 tablets and the test is passed when all the 6 tablets
disintegrate.

23. 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)

24. Limits:
For Uncoated tablets:
Medium Temper
ature
Time
limit
According to
U.S.P.
Simulated
gastric
fluid
37oC Not
exceed
30min
According to
B.P.
water 37oC Not
exceed
15min

25. 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.

26. 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.

27. 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.

28. Disintegration time (min)
Type of
tablet
IP BP USP
Un coated 15 15 5
Coated 60 30 _
Film 30 _ _
Enteric 120 _ 1+2hr
Dispersible 3 3 3

29. 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
•Determine 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 percent
deviaton and none should deviate more than twice the percentage

30. Limits according to U.S.P
·Weight of tablet 130 mg or less then % deviation ±10%
·Weight of tablet 130-324 mg then %deviation= ±7.5%
·Weight of tablet 324 mg or more then %deviation = ±5%
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 %

31. DISSOLUTON TEST
According to USP
Apparatus 1(Rotating basket)
Apparatus 2(Rotating paddle)
Dissolution Acceptance Criteria
Stage No Of
Dosage
Units Tested
Acceptance Criteria
1 6 No dosage unit is <Q+5%
2 6 Avg of 12 units > or =Q% and dosage unit is
<Q-15%
3 12 Avg of 24 units > or =Q% and not more
than 2 units are <Q-15% and no unit is <Q-
25%

32. Leak testing for Strips and Blister packing :
1. Take the required number of strips / blisters as
mentioned in annexure . Check the quality of strips/
blisters for any damages.
2. Tie the collected strips / blisters with a rubber band.
3. Ensure that all strips / blisters are dipped in water and
closethe lid.
4. Connect opening of the desiccator to the vacuum
pump.
5. Apply a vacuum of 300 mm of Hg and close the knob
of thedesiccator.
6. Keep the vacuum for 30sec.

33. 7. Release the vacuum by opening the knob of the
desiccator slowly and open the lid remove the
strips / blisters.
8. Wipe out the traces of water from the strips /
blisters byusing lint free duster .
9. Open the pocket of strips by using scissors to
remove the tablets / capsules.
10. Open the blisters manually.
11.Check for any traces of water inside the strips /
blisters.
12. Number of tablets or capsules, which have
become wet,should not be more than 1%

34. Documentation

39. Reference
Leon Lachman Herbert A.Lieberman, The Theory and
Practice of Industrial Pharmacy,
N.K.Jain,Pharmaceutical Product Development

40. Thank You