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QCtablet

QCtablet

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QCtablet
QCtablet

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Published by: api-3742263 on Oct 15, 2008
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03/18/2014

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QUALITY CONTROL OF SOLID DOSAGE
FORM
A) TABLET:
The quality control of tablets includes following tests. These tests are-

1. Weight variation
2. Friability
3. Hardness
4. Disintegration test
5. Dissolution test

6.Leakage test for strips and blisters.
(1) Weight Variation:-

The volumetric fill of the die cavity determines the weight of the
compressed tablet. In setting up the tablet machine, the fill is adjusted to
give desired tablet weight. The weight of the tablet is the quantity of
granulation that contains the labeled amount of therapeutic ingredients.
After the tablet machine is in operation, the weights of the tablets are
checked routinely, either manually or electronically to ensure that proper
weight tablets are being made.
In general practice, composite samples of the tablets are (usually 10)
taken and weighed throughout the compression process. The composite
weight divided by 10, provides an average weight but contains usual
problems of averaged values. Within the composite sample that has an
acceptable average weight there could be tablets excessively overweight
or underweight. To solve this problem the USP/NF provides limits for the
permissible variations in the weights of the individual tablets expressed
as a percentage of the average weight of the sample.

1

METHOD OF TEST-
The weight of the individual 20 tablets are taken, calculate the average
weight and compare the individual tablets weight to the average. If no
more 2 tablets are outside the percentage limits then it is acceptable.
The weight variation tolerances for uncoated tablets differs depending
upon average tablet weight which is given below.

Average weight of the tablets (mg)
Maximum % difference allowed
80 or less
10
80-250
7.5
More than 250
5
(2) Friability testing:-

The tablets may be subjected to a tumbling motion.e.g.during coating
packaging or transport may cause small particles to abrode from the
surface of the tablet. To examine this, friability test or test to measure
the resistance to abrasion is done. The laboratory friability tester is
known as the \u2018Roche Friabilator\u2019. This device subjects a no. of tablets
to the combined effects of abrasion and shock by utilizing a plastic
chamber that revolves at 25 rpm for 4 minutes dropping the tablets at a
distance of 6 inches with each revolution .The tablets are then dusted
and reweighed .Compressed tablets that lose less than 0.5-1% of their
weights are considered acceptable. Some chewable and effervescent
tablets undergo high friability weight losses. When concave and
especially deep concave punches are used in tableting, and when
punches are in poor condition or worn at their surface edges, tablets
produced results in \u2018whiskering\u2019 at the tablet edge. Such tablets have
higher than normal friability values because the whiskers are removed
in testing.

2

Tablet friability may also be influenced by the moisture content of the
tablet, granulation and finished tablets. A low but acceptable moisture
level acts as a binder. Very dry granulations that contains only
fractional percentages of moisture often produce more friable tablets
than granulations containing 2-4% moisture.

(3) Hardness testing:-

The resistance of the tablets to chipping, abrasion and breakage under
conditions of storage, transportation and handling before usage depends
upon its hardness. The monitoring of tablet hardness is especially
important for drug possess real or potential bioavailability problems or
that are sensitive to dissolution release profiles as a function of
compressive force.
Tablet hardness is defined as, \u2018the force required to break a tablet in a
diametric compression test\u2019.
To perform this test, a tablet is placed between two anvils, force is
applied to anvils, and crushing strength that just causes the tablet to
break is recorded. Hardness is also termed as tablet crushing strength.
There are various devices to test the hardness of the tablet.

1. Monsanto tester
2. Strong-cobb tester
3. Pfizer tester
4. Erweka tester.
5. Schleuniger tester

1. Monsanto Hardness Tester:-
It was developed approximately 50 years ago.
3

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