Ipqc for tablets

Malla Reddy College of Pharmacy
Malla Reddy College of PharmacyMalla Reddy College of Pharmacy
Ipqc for tablets
Contents 
Introduction 
Importance of IPQC 
General IPQC tests 
IPQC tests for tablets 
Documentation
Ipqc for tablets
Ipqc for tablets
Ipqc for tablets
Ipqc for tablets
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Ipqc for tablets
Ipqc for tablets
IPQC Tests For Tablets: 
Hardness 
Friability 
Thickness 
Disintegration 
Weight variation 
Content uniformity 
Dissolution 
Leakage testing for strip and blister packaging
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
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
• MONSANTO TESTER 
• PFIZER TESTER
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
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%.
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
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.
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.
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 
ature 
Time 
limit 
According to 
U.S.P. 
Simulated 
gastric 
fluid 
37oC Not 
exceed 
30min 
According to 
B.P. 
water 37oC Not 
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.
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
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
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 %
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%
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.
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%
Documentation
Ipqc for tablets
Ipqc for tablets
Ipqc for tablets
Ipqc for tablets
Reference 
Leon Lachman Herbert A.Lieberman, The Theory and 
Practice of Industrial Pharmacy, 
N.K.Jain,Pharmaceutical Product Development
Thank You
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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%
  • 39. Reference Leon Lachman Herbert A.Lieberman, The Theory and Practice of Industrial Pharmacy, N.K.Jain,Pharmaceutical Product Development