Professional Documents
Culture Documents
Final Product Quality Control: College of Pharmacy
Final Product Quality Control: College of Pharmacy
COLLEGE OF PHARMACY
I. Objective
To know the different tests and equipment used in determining the final product quality
control of liquid and suspension.
II. Materials
Search engine / any reference books
III. Procedure
1. Below are the finished product quality control tests for liquid and suspension.
1.1 assay of the active ingredient (s)
1.2 assay for degradation product(s)
1.3 identification tests for the active ingredient(s) and possible contaminants
1.4 visual appearance
1.5 color
1.6 odor
1.7 taste
1.8 redispersibility
1.9 suspendibility
1.10 pourability
1.11 viscosity
1.12 isotonicity
1.13 particle size agglomeration and particle size distribution
1.14 clarity
1.15 crystallization and precipitation
1.16 gas evolution
1.17 specific gravity
1.18 pH
1.19 refractive index
1.20 surface tension
1.21 pyrogen testing
1.22 sterility testing
1.23 toxicity testing
1.24 storage condition
1.25 fill volume
1.26 leak test
2. Search for a corresponding procedure and equipment in conducting each test. Attached the
picture(s) for the equipment.
visual appearance
Color
Taste
dispersibility Electrokinetic method: in this zeta potential is
measured by using micro electrophoresis
apparatus and zeta plus. It shows the stability of
a disperse system.
Suspensibility A pharmaceutical suspension is a coarse in
which insoluble particles, generally greater than
1nm, are dispersed in a liquid medium, usually
aqueous.
Pourability Rheological method is used for stability and
pourability of suspension. A practical rheologic
method involves the use of Brookfield
viscometer on a helipath stand, The t-bar
spindle is made to descend slowly into the
suspension, and the dial reading on the
viscometer is then measure of the resistance of
the spindle meets at various levels in a
sediment.
Viscosity Viscosity is a property of liquids that is directly
related to the resistance to flow. Viscosity
measurement is important quality control test
in case of syrups an elixirs. Viscosity and
consistency directly relates with stability of
solutions. If viscosity increases, then there is a
chance of increase in stability.
Isotonicity
particle size agglomeration
and particle size distribution
Clarity The clarity of the formulations before and after
gelling was determined by visual examination of
Gas evolution
Specific gravity
pH A typical pH meter consists of a special
measuring glass electrode connected to and
electronic meter that measures and displays the
pH reading.
Refractive index
Surface tension
Pyrogen testing LAL (limulus amebocyte lysate) assay used to
detect the presence and concentration of
bacterial endotoxins in drugs and biological
products.
Sterility testing Sterility testing attempts to reveal the presence
or absence of of viable micro organisms in a
sample number of containers taken from batch
of product.
Toxicity testing
Storage condition
Fill volume
Leak test