The document discusses quality control tests for suspensions. Suspensions are biphasic liquid dosage forms with solids dispersed in liquid. Quality control ensures adherence to quality criteria and customer requirements by testing for appearance, microscopic particle examination, color/odor/taste, pH, pourability, viscosity, redispersibility, and particle size. These tests help identify issues, ensure proper monitoring of variables affecting quality, and reduce human errors in manufacturing suspensions.
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Quality Control Test For Suspensions
The document discusses quality control tests for suspensions. Suspensions are biphasic liquid dosage forms with solids dispersed in liquid. Quality control ensures adherence to quality criteria and customer requirements by testing for appearance, microscopic particle examination, color/odor/taste, pH, pourability, viscosity, redispersibility, and particle size. These tests help identify issues, ensure proper monitoring of variables affecting quality, and reduce human errors in manufacturing suspensions.
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QUALITY CONTROL
TEST FOR SUSPENSIONS
PRESENTED BY:- BHANU BISWAS
M.PHARM(QUALITY ASSURANCE) 2018-19 MAHARISHI MARKANDESWAR(DEEMED TO BE UNIVERSITY)
March 27, 2018 1
Quality control (QC) is a procedure or set of procedures that ensures that the manufactured product adheres to a defined set of quality criteria or meets the requirements of the customer. Suspension is defined as a biphasic liquid dosage form in which a solid is dispersed in liquid.
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PURPOSE
• To ensure any kind of human errors.
• To ensure the quality of final product.
• To ensure continuous monitoring of process
variables which are going to affect the quality of product.
Particles of suspensions should be well distributed. No hard cake formation of particles. The suspension is poured in a transparent glass container and it should be checked if there is any coagulated material adhering to the inside wall of the container.
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PHOTO MICROSCOPIC EXAMINATION
The suspension is examined for particle size
distribution and crystal habit under microscope with camera.
It is mainly used to differentiate between
flocculated and deflocculated particles.
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March 27, 2018 7 March 27, 2018 8 COLOUR, ODOUR & TASTE This technique is mostly done for orally administrated suspensions.
Variation in colour indicates poor
distribution.
Varialtion in taste is generally due to particle size
and crystal habit.
Change in either colour, odour or taste indicates
chemical instability. March 27, 2018 9 pH Value pH of the phases of suspension also contribute to the stability and characteristics of formulations. So pH of the different vehicles, phases of suspension before mixing and after mixing are monitored and recorded time to time to ensure optimum pH environment. Different methods are: a) Dip a piece of pH paper into the sample. b)pH meter March 27, 2018 10 POURABILITY
This test is carried out to ensure that the final
preparation is pourable and will not cause any problem during filling and during handling by the patient.
March 27, 2018 11
VISCOCITY
Stability of a suspension is dependant on
the sedimentation rate of dispersed phase which is dependant on the viscosity of the dispersion medium.
So this test is carried out to ensure optimum
viscosity of the medium so a stable, redispersible suspension can be formed.
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The calculated values are compared with standard values and if any difference is found necessary corrective action is taken to get optimized viscosity.
The viscosity can be measured by:-
a)cup and bob viscometer b)cone and plate viscometer
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March 27, 2018 14 March 27, 2018 15 REDISPERSIBILITY
If the particles settle they should be easily
redispersible by a moderate amount of shaking
March 27, 2018 16
PARTICLE SIZE
Optimum size of drug particle in the dispersed
phase plays a vital role in stability of final suspension. So this test is carried out by microscopically analysis and find out particle size range of drug then it is compared with optimum particle size required. If any difference is found, strict monitoring of micronization step is ensured. March 27, 2018 17 Particle size can be measured by:- a)optical microscopic method
b)sedimentation method
c)conductivity method
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CONCLUSION
These all steps are carried out to ensure stable,