Quality control test for tablets
By- Prof. Ankita Raikwar
SAM Global University
Diffusion
 Diffusion is the net movement of
anything (for example, atoms, ions,
molecules, energy) generally from a
region of higher concentration to a
region of lower concentration.
Osmosis
 Osmosis - movement
or diffusion of solvent molecules
through a selectively-permeable
membrane from a region of high water
potential (region of
lower solute concentration) to a region
of low water potential (region of higher
solute concentration)
 Osmosis is a vital process in biological
systems, as biological membranes ,
these membranes are impermeable to
large and polar molecules, such
as ions, proteins,
and polysaccharides, while being
permeable to non-polar
or hydrophobic molecules like lipids as
well as to small molecules like oxygen,
carbon dioxide, nitrogen, and nitric
oxide.
Hardness
 Load required to crush tablet when
placed on its edge
 Why?
-to determine need for pressure
adjustment on tablet machine.
-to understand disintergration time
 10 tablets
 Limit- 4-6 Kg (1Kg- 10 N)
 Factors affecting hardness-
compressive force
-amount of binder
-method of granulation
1.Hardness apparatus- Pfizer
 A handy tough and direct dial reading
type tablet hardness tester working as
pair of plairs generates breaking force
in single grip.
This tablet hardness tester offers
accurate and reproducible results
much faster other conventional
hardness testers.
Accuracy : ±0.2kg Least Count : 0.2Kg
 Safe testing Force : 20kg
Maximum Tablet Diameter : 25mm
2.Hardness apparatus-
Monsento
 Hold the Tablet between the jaw and
nozzle in edgewise position.
 Adjust the Scale (by sliding), so that
the zero on the Scale coincides with
the pointer.
 Turn the screw knob slowly till the
tablet breaks.
 The pressure indicated on the dial is in
Kilogram per sq. cm.
Weight variation
 20 tablets
 Weigh 20 tablets randomly
 Determine average weight
 Limit- NMT 2 of in’1=dividual weights
deviate from the average weight, by more
than % deviation given below & none
deviates by more than twice that %.
Wt. Of tablet % deviation
<180 mg ±10%
80-250 mg ±7.5%
250 mg< ±5%
 https://www.indiamart.com/proddetail/tabl
et-hardness-tester-pfizer-type-
2387710797.html
 https://www.slideshare.net/mallikarjunvas
m/quality-control-tests-for-
tablets?qid=0555e3fa-cc69-4b49-871d-
b09698e9cee1&v=&b=&from_search=1
 https://en.wikipedia.org/wiki/Osmosis
 https://www.sciencedirect.com/topics/che
mistry/diffusion#:~:text=Diffusion%20is%
20defined%20as%20the,of%20lower%2
0concentration%20%5B34%5D.

Quality control parameters.pptx

  • 1.
    Quality control testfor tablets By- Prof. Ankita Raikwar SAM Global University
  • 2.
    Diffusion  Diffusion isthe net movement of anything (for example, atoms, ions, molecules, energy) generally from a region of higher concentration to a region of lower concentration.
  • 4.
    Osmosis  Osmosis -movement or diffusion of solvent molecules through a selectively-permeable membrane from a region of high water potential (region of lower solute concentration) to a region of low water potential (region of higher solute concentration)
  • 5.
     Osmosis isa vital process in biological systems, as biological membranes , these membranes are impermeable to large and polar molecules, such as ions, proteins, and polysaccharides, while being permeable to non-polar or hydrophobic molecules like lipids as well as to small molecules like oxygen, carbon dioxide, nitrogen, and nitric oxide.
  • 7.
    Hardness  Load requiredto crush tablet when placed on its edge  Why? -to determine need for pressure adjustment on tablet machine. -to understand disintergration time
  • 8.
     10 tablets Limit- 4-6 Kg (1Kg- 10 N)  Factors affecting hardness- compressive force -amount of binder -method of granulation
  • 9.
    1.Hardness apparatus- Pfizer A handy tough and direct dial reading type tablet hardness tester working as pair of plairs generates breaking force in single grip. This tablet hardness tester offers accurate and reproducible results much faster other conventional hardness testers. Accuracy : ±0.2kg Least Count : 0.2Kg
  • 10.
     Safe testingForce : 20kg Maximum Tablet Diameter : 25mm
  • 11.
    2.Hardness apparatus- Monsento  Holdthe Tablet between the jaw and nozzle in edgewise position.  Adjust the Scale (by sliding), so that the zero on the Scale coincides with the pointer.  Turn the screw knob slowly till the tablet breaks.  The pressure indicated on the dial is in Kilogram per sq. cm.
  • 13.
    Weight variation  20tablets  Weigh 20 tablets randomly  Determine average weight  Limit- NMT 2 of in’1=dividual weights deviate from the average weight, by more than % deviation given below & none deviates by more than twice that %. Wt. Of tablet % deviation <180 mg ±10% 80-250 mg ±7.5% 250 mg< ±5%
  • 14.
     https://www.indiamart.com/proddetail/tabl et-hardness-tester-pfizer-type- 2387710797.html  https://www.slideshare.net/mallikarjunvas m/quality-control-tests-for- tablets?qid=0555e3fa-cc69-4b49-871d- b09698e9cee1&v=&b=&from_search=1 https://en.wikipedia.org/wiki/Osmosis  https://www.sciencedirect.com/topics/che mistry/diffusion#:~:text=Diffusion%20is% 20defined%20as%20the,of%20lower%2 0concentration%20%5B34%5D.