Disintegration:

Parameter BP IP USP
No. Of 6 6 6
cylinder
Length of 75.0 to 80.0 mm long 77.5 ± 2.5 mm 77.5 ± 2.5 mm
cylinder
internal 21.5 mm 21.5 mm 20.7 to 23 mm
diameter
Thickness 2 mm 2 mm 1.0 to 2.8 mm
Volume of 1000ml 1000ml 1000ml
vessel
in the highest 15mm below the 25mm below the 15mm below the
point surface of the liquid surface of the liquid surface of the liquid
the wire mesh
is at least
lowest 25mm above the 25mm above the 25mm above the
position the bottom of the beaker bottom of the beaker bottom of the
wire mesh is and the upper and the upper beaker and the
at least open ends of the tubes open ends of the upper
remain above the tubes remain above open ends of the
surface of the liquid. the surface of the tubes remain above
liquid. the surface of the
liquid.
the at 36° to 38°C at 37º ± 2ºC between 35°C and
temperature of 39°C
the liquid
frequency between 28 and 32 between 28 and 32 between 29 and 32
cycles per minute cycles per minute cycles per minute
Method The tablets or capsules If 1 or 2 tablets or all of the tablets
pass the test if all six capsules fail to
have disintegrated
have disintegrate repeat completely. If 1 or 2
disintegrated the teston 12
tablets fail to
additional tablets or disintegrate
capsules; not less completely, repeat
than 16 of thetotal ofthe test on 12
18 tablets or
additional tablets.
capsules tested
The requirement is
disintegrate. met if not fewer
than 16 of the total
of 18 tablets tested
are disintegrated.
for Enteric- 0.1M 0.1M hydrochloric Place 1 tablet in
coated Tablets hydrochloric acid for acid and operate each of the six tubes
120 minutes. Without the discs for of the basket and, if
Replace the liquid in 2 hours. the tablet has a
the beaker with mixed Replace the liquid in soluble external
phosphate buffer pH the beaker with sugar coating,
6.8, add a disc to each mixed phosphate immerse the basket
 tube and buffer in water at room
operate the apparatus pH 6.8, add a disc to temperature for 5
for a further 60 each tube and minutes. Then
minutes. operate the apparatus operate the
The tablets for apparatus using
pass the test if all six a further 60 minutes. simulated gastric
have disintegrated. If fluid TS maintained
the tablet fails to at 37 ± 2 as the
comply because of immersion fluid.
adherence to the After 1 hour of
disc, operation in
repeat the test on a simulated gastric
further 6 tablets fluid TS, lift the
without the discs. basket from the
The fluid, and observe
tablets pass the test the tablets: the
if all six have tablets show no
disintegrated. evidence of
disintegration,
cracking, or
softening. Operate
the apparatus, using
simulated intestinal
fluid TS maintained
at 37 ± 2 as the
immersion fluid, for
the time specified in
the monograph. Lift
the basket from the
fluid, and observe
the tablets: all of the
tablets disintegrate
completely. If 1 or 2
tablets fail to
disintegrate
completely, repeat
the test on 12
additional tablets:
not fewer than 16 of
the total of 18
tablets tested
disintegrate
completely.
Buccal Tablets ---------- ------------ Apply the test for
Uncoated Tablets.
After 4 hours, lift
the basket from the
fluid, and observe
the tablets: all of the
tablets have
 disintegrated. If 1 or
2 tablets fail to
disintegrate
completely, repeat
the test on 12
additional tablets:
not fewer than 16 of
the total of 18
tablets tested
disintegrate
completely.
Sublingual ---------- ----------- Apply the test for
Tablets Uncoated Tablets.
At the end of the
time limit specified
in the individual
monograph: all of
the tablets have
disintegrated. If 1 or
2 tablets fail to
disintegrate
completely, repeat
the test on 12
additional tablets:
not fewer than 16 of
the total of 18
tablets tested
disintegrate
completely.
Hard Gelatin ------------ ------------ Apply the test for
Capsules/ Soft Uncoated Tablets.
Gelatin Attach a removable
Capsules wire cloth, which
has a plain square
weave with 1.8- to
2.2-mm mesh
apertures and with a
wire diameter of
0.60 to 0.655 mm,
to the surface of the
upper plate of the
basket-rack
assembly. Observe
the capsules within
the time limit
specified in the
individual
monograph: all of
the capsules have
disintegrated except
 for fragments from
the capsule shell. If
1 or 2 capsules fail
to disintegrate
completely, repeat
the test on 12
additional capsules:
not fewer than 16 of
the total of 18
capsules tested
disintegrate
completely.
Disintegration Test for Suppositories and Pessaries
Material A transparent sleeve of A transparent sleeve ----------
glass or plastic of glass or plastic
Height 60 mm 60 mm ----------
internal 52 mm 52 mm ----------
diameter
Thickness appropriate appropriate ----------
metal device consisting of two consisting of two ----------
stainless steel discs stainless steel discs
each of which contains each of which
39 holes, each 4 mm in contains 39 holes,
diameter, each 4 mm in
diameter,
Distance of 30mm 30mm ----------
disc
Method By taking 1 By taking 1 ----------
Suppository and Suppository and
Pessary perform the Pessary perform the
test. test.
Repeat the test by Repeat the test by
taking 2 Suppositories taking 2
and Pessaries. Suppositories and
4lit of medium for Pessaries.
each suppository. 4lit of medium for
Temp. 36-37°C . each suppository.
For 3 suppositories Temp. 36-37°C .
12lit. For 3 suppositories
After each 10 minutes 12lit.
invert each apparatus After each 10
without removing it minutes
from the liquid. invert each apparatus
Disintegration is without removing it
considered to be from the liquid.
complete when the Disintegration is
moulded considered to be
pessary or suppository complete when the
a) is completely moulded
dissolved or pessary or
b) has dispersed into suppository
its component parts, a) is completely
which may remain dissolved or
on the surface (in the b) has dispersed into
case of melted fatty its component parts,
substances), which may remain
sink to the bottom (in on the surface (in the
case of insoluble case of melted fatty
powders) or substances),
dissolve (in case of sink to the bottom
soluble components) or (in case of insoluble
may be powders) or
distributed in one or dissolve (in case of
more of these ways or soluble components)
c) has become soft or may be
with appreciable distributed in one or
change in shape, more of these ways
without necessarily or
separating into its c) has become soft
components, and with appreciable
the mass has no solid change in shape,
core which cannot be without necessarily
pressed with separating into its
a glass rod. components, and
Disintegration occurs the mass has no solid
in not more than 30 core which cannot be
minutes for fat-based pressed with
suppositories and in a glass rod.
not more than
60 minutes for water-
soluble suppositories,
unless otherwise
justified and authorised