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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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Ajitha Azhakesan
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0% found this document useful (0 votes)
392 views

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.

Uploaded by

Ajitha Azhakesan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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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.

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QUALITY CONTROL
TESTS
 Appearance
 Photo microscopic examination
 Color, odour & taste
 pH value
 Pourability
 Viscosity
 Redispersibility
 Particle Size
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APPEARANCE

 It must appear uniform and elegant.


 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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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.

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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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REDISPERSIBILITY

 If the particles settle they should be easily


redispersible by a moderate amount of shaking

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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,


safe and high quality of suspension products.

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March 27, 2018 20

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