5. MADE BY:
• Perhe Abdullah Roll#2k9/Pha/66
• Sadia Salahuddin Roll#2k9/Pha/73
• Sana Ghori Roll#2k9/Pha/81
• Shah Bibi Roll#2k9/Pha/85
• Rabia Ghazal Roll#2k9/Pha/122
(MORNING)

6. CONTENTS
• Introduction
• Quality control tests of
TABLETS
• Quality control tests of
CAPSULES

7. INTRODUCTION
Quality control, or QC for short, is a
process by which entities review the
quality of all factors involved in
production.

8. Quality Control Tests Of
TABLETS

9. QUALITY CONTROL
TESTS OF
TABLETS
PHYSICAL TESTS CHEMICAL TESTS
2: Tablet Thickness
1: Hardness Test and 1: Content Uniformity 2: Assay
Diameter
4: Disintegration 5: Weight Variation
3: Friability Test 3: Dissolution Test
Test Test

12. Hardness
 It is defined as the force required to break a
tablet in a diametric compression test.
 Tablet requires a certain amount of strength
or hardness and resistance to friability to
withstand mechanical shakes of handling in
manufacture, packaging and shipping.
 Tablet Hardness Test is performed to check
that the manufactured tablet is of desired
hardness.

13. Hardness Testers
1. Strong-Cobb
2. Stokes-Monsanto
3. Eureka
4. Pfizer

14. 1:Strong-Cobb
• The tablet is
placed between
two jaws that
crush the tablet.
• The machine
measures the
force applied to
the tablet and
detects when it
fractures.

15. 2:Stokes-Monsanto
 Tube like structure
in which tablet is
placed.
 Force in kg is
required to break
tablet.
 4kg is general
range

16. 3: Eureka
 The breaking force is applied by a beam
fastened to one end to a pivot
 The motor moves a weight along the beam at
a constant speed and increases the force
against the tablet on which the other end of
the beam rests
 When the tablet breaks, a microswitch is
activated that stops the motor
 An indicator fastened to the weight shows
the breaking strength on scale in kilogram
units

17. Eureka instrument

18. 4: Pfizer

19. Factors Affecting Hardness
 Pressure applied during the compression
 Cohesive forces between ingredients
especially binder have more cohesive
forces
 Density

21. Thickness and Diameter
 Tablet thickness and diameter tests are also
very important qc tests
 Very thick tablet affects packaging either in
blister or plastic container
 The thickness for majority of tablets may vary
from 2mm to 4mm
 The diameter of tablets may vary from 4mm to
13mm

22. Instruments used
 For diameter: Vernier Calipers
 For thickness: Micrometer Screw Gauge

23. Vernier Callipers

24. Micrometer Screw Gauge

26. 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.

27. Friabilator
► Friabilator is a round drum
► It has diameter of 2.87mm and depth of
38mm
► In diameter a horizontal axis is present
► Friabilator is connected to timer to indicate
its rotations
► It is rotated in clockwise direction

28. Rotating drum
Timer

29. Test Method
► Weigh 20 tab altogether = W1
► Put these tablets in the friabilator and adjust
the instrument at 100 rpm (i.e. = 25 rpm for 4
min)
► Weigh the 20 tablets (only the intact ones) =
W2
► The difference between W1 and W2 gives
weight loss (i.e. Friability)
► Weight loss of 1-5% is acceptable

31. Disintegration
 For most tablets , the first important step towards
formation of solution is breakdown of the tablet
into smaller particles or granules , this process is
known as 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

32. Disintegration apparatus
The apparatus consists of;
 Basket rack assembly
 A suitable vessel for the immersion liquid
 A thermostatic arrangement for heating the fluid
between 35°C and 39°C
 A device for raising and lowering the basket in
the immersion fluid at a constant frequency rate
between 28 and 32 cpm through a distance of
not less than 5cm and not more than 6cm

33.  BASKET RACK ASSEMBLY:- It consists of;
 Six open ended glass tubes each 7.75cm long and
having an inside diameter of approximately 21.5mm
and a wall 2mm thick
 The tubes are held in a vertical position by two
plastic plates
 Each tube is provided with a slotted and perforated
cylindrical disk

34. Glass
Tubes

35. Disintegration test is
performed with different types
of tablets
1. Uncoated tablets
2. Coated tablets
3. Enteric coated tablets
4. Buccal tablets
5. Sublingual tablets

36. Different liquid mediums are
used in disintegration test
 Water
 Simulated gastric fluid (PH= 1.2)
 Simulated intestinal fluid (PH= 7.5)

37. SIMULATED GASTRIC FLUID
 Sodium chloride -------------------- 2gm
 Pepsin -------------------------------- 3.2gm
 Hydrochloric acid ------------------ 7ml
 Water (q.s to make) --------------- 1000ml
SIMULATED INTESTINAL FLUID
 Potassium phosphate ----------------- 6.8gm
 Pancreatin -------------------------------- 10gm
 Sodium hydroxide ---------------------- 190ml
 Water (q.s to make) --------------- 1000ml

38. 1: Test method for Uncoated tablets
 Place 1 tablet in each of the 6 tubes of the basket,
add a disk to each tube
 Use water as immersion fluid maintained at 37°C
 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

39.  if more then two tablets (from the 18) fail to
disintegrate, the batch must be rejected.

40. 2: Test method for coated tablets
 Place 1 tablet in each of the 6 tubes of the basket,
add a disk to each tube
 To remove or dissolve the coat, immerse the basket
in distilled water for 5min.
 Then add a disk to each tube and operate the
apparatus using simulated gastric fluid maintained at
37°C
 If one or two tablets fail to disintegrate, repeat on
12 tablets.

41.  So 16 tablets from the 18 must completely
disintegrate within the time
 If two or more not disintegrated the batch is
rejected

42. 3: Test method for Enteric coated
tablets
 Place 1 tablet in each of the 6 tubes of the basket,
add a disk to each tube
 Put in distilled water for five minutes to dissolve the
coat.
 Then operate the apparatus without the disks using
simulated gastric fluid as immersion fluid maintained
at for one hour.
 After one hour, lift the basket and observe the
tablets, the tablets show no evidence of
disintegration, cracking or softening

43.  Then add disk to each tube and operate the
apparatus using simulated intestinal fluid
maintained at 37°C 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 batch must be rejected.

44. 4: Test method for Buccal tablets
 Place 1 tablet in each of the 6 tubes of the basket
 Use water as immersion fluid maintained at 37°C
 Operate the apparatus for 4 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 batch must be rejected

45. 5: Test method for Sublingual tablets
 Place 1 tablet in each of the 6 tubes of the basket
 Use water as immersion fluid maintained at 37°C
 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 batch must be rejected

46. Factors Affecting Disintegration
 Quantity of disintegrating agent
 Compactness
 Cohesive forces between the ingredients
 Hardness

48. Weight Variation
 The actual weight of a tablet is determined by
the diameter of the die and the weight
adjustment cam on the tablet machine
 The weight control on the tablet machine is
routinely adjusted at intervals to ensure that
the specified weight is being reproduced
 This test is perform to ensure uniform
distribution of ingredients throughout batch

49. Test Method
 Take 20 tablets
 Weigh individually
 Determine the average weight of 20 tablets
 Compare individual tablet weight to average
weight
 Not more than 2 of the individual weights
deviate from the average weight by more than
the percentage deviation
 And none deviates by more than twice that
percentage.

50. Weight variation tolerances for
uncoated tablets in U.S.P XVII
Average weight of Percentage Differences
Tablet (mg)
130 or less 10.0
130-324 7.5
More than 324 5.0

51. Causes of Weight Variation
1. Poor flow of granules
2. Variation in size of granules due to
improper sieving
3. Presence of very fine granules
4. Improper adjustment of machine
5. Improper flow rate

54. Content Uniformity
• The content uniformity test is used to
ensure that every tablet contains the
amount of drug substance intended with
little variation among tablets within a
batch.
• The individual variation in drug content
might result from a failure to maintain the
homogeneity of a tablet granulation
through the processing steps leading to
compression.

55. Test Method
• 30 Tablets are kept aside .
• 10 tablets are assayed .
• 9 Tablets should have %limit of 85-115%
of average of tolerances specified in
respective monograph .
• If more than 1 Tablet has 85-115% then,
20 Tablets are assayed Not more than 1
Tablet should have 75-125%

57. Assay
• Assay is performed in finished form to
know the amount or concentration of
active ingredients present in tablets
• It include HPLC, spectroscopy, chemical
tests etc

58. Test Method
STAGE-1
• Weigh about 20 tablets and crush them
• To aliquot add 30ml (0.5N) NAOH
• Titrate the mixture with 0.5N HCl
• Use phenol red as indicator
• The point at which red color turns to
yellow indicates the end point and the
amount of HCl used is noted

59. STAGE-2
• Repeat the titration with blank solution of 30ml
(0.5N) NaOH
• Calculate the difference of HCl consumed in
both titrations.
• NOTE: Each ml of 0.5N NaOH is equivalent to
0.04502gm or 45mg of active ingredient

60. Formulae
• Weight of 1 tablet = Total weight of tablet
number of tablets
• Aliquot = Total weight of 1 tablet
Active (claimed)
• %age purity = volume consumed x average weight
of tablets x factor x100
active (labelled claimed) x aliquot

62. Dissolution
• The release of drug from the tablet into
solution per unit time under standardize
condition is called dissolution test.

63. Dissolution Apparatus
1. Rotating basket method APPARATUS-I
2. Paddle method APPARATUS-II
3. Reciprocating cylinder method
APPARATUS-III
4. Flow through cell method APPARATUS-IV
5. Paddle over disk method APPARATUS-V
6. Cylinder method APPARATUS-VI
7. Reciprocating disk method APPARATUS-
VII

64. 1:Rotating basket method
APPARATUS-I
• The apparatus consists of a cylindrical
basket held by a motor shaft
• The basket holds the sample and rotates
in a round flask containing the dissolution
medium
• The entire flask is immersed in a constant
temperature bath set at 37°C
• The rotating speed is 100 rpm

66. 2: Paddle method
APPARATUS-II
• The apparatus consists of a special, coated
paddle that minimizes the turbulence due to
stirring
• The paddle is attached vertically to a variable
speed motor that rotates at controlled speed
• The apparatus is housed in constant
temperature water bath maintained at 37°C
• Rotating speed is 50 rpm for solid dosage
forms

67. Paddle

68. 3: Reciprocating cylinder
method APPARATUS-III
• The apparatus consists of a set of
cylindrical, flat bottomed glass vessels
• Temperature maintained at 37°C
• Used for dissolution testing of extended
released products

69. 4: Flow through cell method
APPARATUS-IV
• The apparatus consists of a reservoir for
dissolution medium and a pump that forces
dissolution medium through cell holding the
test sample
• Flow rate ranges from 4 to 16ml/min
• Temperature maintained at 37°C

70. 5: Paddle over disk method
APPARATUS-V
• The apparatus consists of a sample holder
or disk assembly that holds the product
• Temperature maintained at 32°C

71. 6: Cylinder method
APPARATUS-VI
• It is modified basket method
• In place of basket, a stainless steel
cylinder is used to hold the sample
• Temperature maintained at 32°C

72. 7:Reciprocating disk method
APPARATUS-VII
• A motor drive assembly is used to
reciprocate the system vertically and
sample is placed on disk shaped holders
• Temperature maintained at 32°C

73. Test method
• Total tablets taken = 24
• S1 : 6 tablets taken
• Acceptable: If all of the tablets are not less than
(NLT) the monograph tolerance limit (Q)= ± 5%.
• If S1 fails S2 : Another 6 tables are taken
• Acceptable : If average of 12 tablets is ≥ Q &
no tablet is less than Q-15%
• If S2 fails S3 : 12 tablets taken
• Acceptable : No tablet less than Q & not more
than 2 tablets = Q-15%.
• USP limit for dissolution : NLT 75% of tablet
dissolve in 45 min.

74. Quality Control Tests of
CAPSULES

75. Quality Control
Tests
Of CAPSULES
2: Uniformity of
1: Disintegration test Weight

77. Disintegration of
Capsules
• The disintegration of capsules is different
from those of tablets because the
determination of end point is difficult owing
to the adhesive nature of shell.
• The shell pieces after disintegration may
agglomerate forming large mass of gelatin
taking more time to dissolve and may
adhere to the mesh thus, blocking the
holes.

78. Test method
• Place one capsule in each of the tubes of the
basket with water or any other specified
medium maintained at 37C.
• Attach a removable wire cloth with a plain
square weave of 1.8-2.2 mm of mesh aperture
and a wire diameter of 0.60-0.655 mm to the
surface of upper rack of the basket assembly.
• Observe the capsules for a time limit
• At the end of prescribed time, all of the
capsules must have been disintegrated
excluding the fragments from the capsule
shell.

79. • If 1 or 2 capsules fail, the test should be
repeated on additional of 12 capsules.
• Then, not fewer than 16 of the total 18
capsules tested should disintegrate
completely.

81. Types of Capsule
• Hard Gelatin Capsule
• Soft Gelatin Capsule

82. Test Method A: For Hard
Gelatin Capsule
• Take 20 capsules and weigh individually
• Empty the capsules and weigh their shells
(made up of gelatin)
• Take the differences of these two weights
• Differences between the weights
represents weight of the contents
• Calculate the average weight of the
contents of 20 tablets

83. • The weight of the contents of each
capsule does not deviate from the average
weight by a greater percentage than
shown in column A
• For two capsules, the weight of the
contents may deviate by not more than the
percentage shown in column B

84. Weight variation tolerances for
capsules
Average Percentage Deviation
Weight
A B
0.120 g or less 10% 20%
More than 7.5% 15%
0.120 g

85. Test Method B: For Soft Gelatin
Capsule
• Take 20 capsules and weigh individually
• Weigh a capsule, open it without loss of
shell material
• Express as much of the contents as
possible
• Wash the shell with solvent ether, reject
the washings, allow the shell to stand until
ether is completely evaporated and odour
of ether is no longer perceptible
• Then weigh the empty shell

86. • Calculate differences between weigh of
each capsule and that of empty shell
• The differences between weights
represents the weight of the contents
• Calculate the average of the weight of the
contents of 20 capsules
• the weight of the contents of each
capsule does not differ from the average
weight by more than 7.5%
• Except that for one capsule the weight of
the contents may differ by not more than
15%