2. INTRODUCTION :
• IPQC stands for in process quality control.
• These are checks that are carried out before the
manufacturing process is completed.
• In-process materials should be tested for identity,
strength, quality and purity as appropriate and
approved or rejected by the quality control unit
during the production process.
3. TESTS :
• Thickness and Diameter
• Weight variation
• Drug content
• Disintegration time
• In-vitro dissolution
4. GENERAL APPEARANCE :
1. SIZE AND SHAPE :The size and shape of the
tablet can be dimensionally described monitored
and controlled. It is determined by the tooling
during the compression process .
2. COLOR AND ODOUR : Colors used for rapid
identification and consumer acceptance. But it
must be uniform within a single tablet, from tablet
to tablet and from lot to lot.The presence of an
odor in a batch of tablets could indicate a stability
e.g. the characteristic odor of acetic acid in
degrading aspirin tablets .Taste is important in
consumer acceptance of chewable tablets
5. 3.THICKNESS : Thickness of individual tablets may
be measured by a micrometer.Tablet thickness
should be controlled within a ± 5 % variation of a
standard.Thickness must be controlled to facilitate
packaging. It is expressed in mm .
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 .
• Determine the individual contents of active
substance(s) of 10 tablets taken at random .
• Tablets fail to comply with test if each individual
content is between 85 % - 115 % of the average
content or if one individual content is outside the
limits of 75 percent to 125 percent of the average
7. • If one individual content is outside the limits of
85% - 115 %, but within the limits of 75 % - 125 %,
determine the individual contents of another 20
tablets taken at random.
• The tablet complies with the test if not more than
one of the individual contents of the 30 tablets is
outside 85 % - 115 % of the average content and
none is outside the limits of 75 % - 125 % of the
average content .
8. WEIGHT VARIATION TEST :
• weighting 20 tablets individually calculating the
average weights and comparing the individual
tablet weights to the average.The value of weight
variation test is expressed in percentage.The
following formula is used .
WeightVariation = (Iw – Aw)/Aw *100%
• The tablet complies with the test if not more than 2
of the individual masses deviate from the average
mass by more than the percentage deviation .
9. LIMITS : USP
AVG WEIGHT (mg) %DEVIATION
130 or Less 10
324 or more 5
AVG WEIGHT (mg) %DEVIATION
84 or more 10
250 or more 5
LIMITS : IP
10. HARDNESS :
• Tablet requires a certain amount of strength or
hardness and resistance to friability to withstand
mechanical shocks of handling in manufacture,
packaging and shipping. Hardness generally
measures the tablet crushing strength.
• It is the load required to crush the tablet when
placed on its edge.
11. • It is measured to ;
To determine the need for pressure adjustments on the
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 batch.
If the disintegration is within limit, we accept the batch.
If Hardness is high + disintegration is within a time
accept the batch.
12. 1 . FACTORS AFFECTING HAEDNESS :
• Compression of the tablet and compressive force.
• Amount of binder. (More binder à more hardness)
• Method of granulation in preparing the tablet .
2 . LIMITS : (Take 5 tablets and avg out )
Oral tablets 4-10 kg
Chewable tablets 3 kg
Sustained release tablets 10-20 kg
14. FRIABILITY :
• It is tendensy of tablets to powder,chip or fragment and
this can affect the elegance appearance,consumer
acceptance,tablet weight variation or content uniformity
• Friability of a tablet can determine in laboratory by Roche
friabilator.This consist of a plastic chamber that revolves
at 25 rpm, dropping the tablets through a Distance of six
inches in the friabilator, which is then operate for 100
revolutions.The tablets are reweighed.
• Compress tablet that lose less than 0.5 to 1.0 % of the
Tablet weigh are consider acceptable.
• It is determined by the following formula :
Friability = (Iw – Fw)/Iw * 100%
• Some chewable ane effervescent tablets are highly friable
so required special packaging .
15. DISINTEGRATION :
• It is time required for the tablet to breck down in
• Disintegration test is an official test.
• Disintegration test is not performed for controlled
& sustained release tablets.
16. • Apparatus consist of 6 glass tubes that are 3 inches
long, open at the top, and held against a 10-mesh
screen at the bottom end of the basket rack assembly.
• One tablet is placed in each tube and the basket rack is
positioned in specified medium at 37 ± 2 °C
• A standard motor driven device is used to move the
basket assembly containing the tablets up and down
through distance of 5-6 cm at a frequency of 28-32
cycles per minute. Perforated plastic disc placed on the
top of tablets and impart an abrasive action to the
tablets and prevent floating of tablets .
17. • Starts disintegration with 6 tablets .
• If 1 or 2 tablets fail to disintegrate completely,
repeat the test on 12 additional tablets.The
requirement is met if not less than 16 of the total of
18 tablets tested are disintegrated .
18. LIMITS : USP
Uncoated Not more than 15 mins
Enteric coated 60 mins
Film coated 30 mins
Effervescent Less than 5 mins
Sublingual 3 mins
Dispersible 3 mins
19. DISSOLUTION TEST :
• Dissolution is process by which solid enters in a
• The dissolution rate is defined as the amount of
drug substance that goes into solution per time
under standerdized condition of liquid/solid
interface,tempreture and solvent composition .
• Dissolution test is used to predict bioavailability
and to determine bioequivalance .
20. DISSOLUTION APPARATUS :
APPARATUS NAME DRUG PRODUCT
Apparatus 1 Rotating basket Tablets
Apparatus 2 Paddle Tablets,Capsule,Modified drug
Apparatus 3 Reciprocating
Extended release drugs
Apparatus 4 Flow cell Lower water soluble drugs
Apparatus 5 Paddle over disk Transdermal drug product
Apparatus 6 Cylinder Transdermal drug product
Apparatus 7 Reciprocating disk Transdermal drug product
Rotating bottle Non-USP Extended release drug
Diffusion cell Non-USP Ointments,Creams,Transdermal
21. DISSOLUTION TESTING AND
INTERPRETATION IP STANDARDS :
1 S1 6 Each unit is < D* + 5
2 S2 6 Average of 12 units (S1 +S2)
is equal to or greater than
(> )D, and no unit is less than
D - 15 percent**
3 S3 12 Average of 24 units
(S1+S2+S3) is equal to or
than (> )D, not more than 2
units are less than d-15
percent** and no unit is less
than d-25 percent**