Document Title:

STANDARD OPERATING
PROCEDURE Physical tests for Tablets
(Weight Variation Test)

Sr.No.: Subject: Date Effective:

IPS/PQM/SOP/00/03 Pharmaceutical Quality

Management

Written By: Approved By: Checked By:

Sign: Date: Sign: Date: Sign:

Designation: Designation:

1. Objective:
To study the weight variation test for tablets

2. Scope:
Drugs in the form of tablets are one of the main products of pharmaceutical industries.
Active ingredients (i.e. the drug), filler and binder materials are thoroughly mixed
usually in drum mixtures to prepare a homogeneous granular mass. Measured quantities
if these granules are then compressed in high speed rotary die punch compressors to
make the tablets. The active ingredient content of tablet is prescribed by various
pharmacopoeia. However, the quantities of the other materials and thus the weight of the
tablets are fixed by the formulation of the manufacturer. Tablet weight is mainly
affected by factors such as tooling of the compression machine, head pressure, machine
speed and flow properties of the powder. Inconsistent powder or granulate density and
particle size distribution are common sources of weight variation during compression.
Variation between tablet with respect to dose and weight must be reduced to a minimum.
Uniformity of weight is an in- process test parameter which ensures consistency of
dosage units during compression.

3. Responsibility:
Pharm –D students, 7th semester.

4. Requirements:
 4.1 Apparatus:

o Weighing balance
o Watch glass

5. Procedure:
5.1 Select the appropriate balance for the quantity and accuracy needed.
5.2 The balance is placed in a suitable location with sufficiently low level of vibrations &
air current.
5.3 Place the receiver (watch glass) on the balance in the center of the pan & press
appropriate tare key on balance.
5.4 Weigh individually 20 whole tablets, and calculate the average weight.
5.5 The requirements are met if the weights of not more than 2 of the tablets differ from
weight by more than the percentage listed in the accompanying table and no tablet differs in
weight by more than double that percentage.
5.6 If the coated tablets do not conform to the criteria in the accompanying table, place 20
tablets in a beaker of water at 37° and swirl gently for not more than 5 minutes. Examine the
cores for evidence of disintegration and repeat the procedure for a shorter time if disintegration
has begun. Dry the cores at 50° for 30 minutes. Accurately weigh 20 individual tablet cores, and
calculate the average weight.
Table:
BP Limit USP
80 mg or less ± 10% 130mg or less
More than 80mg or ± 7.5% 130mg to 324mg
Less than 250mg
250mg or more ± 5% More than 324mg

5.7 Maximum weight limit of tablet = average weight + (average weight × percentage limit)
5.8 Minimum weight limit of tablet = average weight - (average weight × percentage limit)

6. Precautions:
6.1The balance user should check the balance environment calibration & balance
uncertainties.
6.2 Do not assume that the balance has been left in proper operating condition by previous
person.