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UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA

COLLEGE OF PHARMACY

ENRICHMENT ACTIVITY NO. 1


Name :______________________
FINAL PRODUCT QUALITY CONTROL Date :______________________
OF LIQUID & SUSPENSION Rating :______________________

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.

PHARMACEUTICAL ANALYSIS 2 LECTURE


UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA
COLLEGE OF PHARMACY

assay of the active the “active ingredients” of a pharmaceutical are


ingredient those that deliver the intended results.
“Titration” is a method of determining the
concentration of dissolved solutions by applying
trace amounts of reagents.

assay for degradation Titration for Degradation products are


product unwanted chemicals that can develop during
the manufacturing, transportation, and storage
of drug products and can affect the efficacy of
pharmaceutical products.
identification tests for the
active ingredient(s) and
possible contaminants

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

PHARMACEUTICAL ANALYSIS 2 LECTURE


UNIVERSITY OF PERPETUAL HELP SYSTEM DALTA
COLLEGE OF PHARMACY

the formulations under light alternatively


against white and black backgrounds.
crystallization and
precipitation

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

PHARMACEUTICAL ANALYSIS 2 LECTURE

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