QUALITY CONTROL OF

SUPPOSITORIES

Ms. RIFFAT
 QUALITY CONTROL TESTS OF
SUPPOSITORIES
• Appearance of suppositories
• Uniformity of weight
• Liquefaction/Softening Time test
• Melting range test/Disintegration
• Fragility test/Breaking Test.
Chemical testing:
• Dissolution test
• Assay of active ingredients
 OFFICIAL QUALITY CONTROL
TESTS
• Procedures listed in the US Pharmacopeia
(USP30-NF25) for manufactured
suppositories include:
• Identification,
Assay. And in some
cases:
• Water content,
• Residual solvent
• Dissolution
• Content uniformity
 Objectives
• Identification test
• Uniformity of weight test
• Discuss about Melting Range Tests
• Liquefaction/Softening Time Test
• Breaking test
 Identification
• Identification tests/Visual Inspection:
• Color and the surface characteristics are
assess.
• It is important to check for the absence of
fissuring, exudation, sedimentation
• Migration of the active ingredients.
• Suppositories can be observed as an intact
unit and also by splitting them longitudinally.
 Weight Uniformity test
• Weigh 20 suppositories individually. w1, w2,
w3….w20 –
• Weigh all the suppositories together = W. -
Calculate the average weight = W/20.
• Limit: Not more than 2 suppositories differ
from the average weight by more than 5%,
and no suppository differs from the average
weight by more than 10%.
 Melting range/Disintegration test
• Micro melting range test: conducted on
fat based suppositories, in a capillary
tube.
• Macro melting range test: conducted on
whole suppository, use USP
Disintegration apparatus at body temp.
• Purpose of test:
In vitro drug release pattern measured by this
apparatus
 Liquefaction/Softening Time Test
• Modified form of Melting range test.
• U-tube immersed partially in
constant temperature water bath.
• It is a measure of physical stability of product
• Temp: 35.5 -37 C
• Ref: Leon Lachmann or hand out
 Breaking/Fragibility test
• Fragibility test/breaking/mechanical strength
test/crushing test
• Test is designed to measure the mechanical
strength of suppository.
• A good result is at least 1.8–2 kg pressure.
 Mechanical strength/breaking
apparatus:

. Double wall chamber

. Test suppository
. Rod
. Disc for weights
. Weights
 Contd.

• Purpose: To verify that the suppository can

be transported under normal conditions, and
administered to the patient
• Limit: A good result is at least 1.8–2
kg pressure.
Do you have any question…?

THANK YOU
 Reference
• Theory & Practice of Industrial
Pharmacy, Leon Lachman, pp:585-588
• On line book chapter” Quality control
of Suppositories”