Comparison of various disssolution specification as per IP/ BP/ USP/ EP

Comparison of various disssolution
specification as per IP/ BP/ USP/ EP
Dosage form
BP
Uncoated
tablet
(A)Basket Apparatus
(B)Paddle Apparatus
For (A) & (B) use
1000ml vessel, 36.5˚37.7˚C, pH ±0.05 unit,
speed ±5%, 25±2mm
distance between
lowest point of vessel
and lowest point of
rotating element.
(C)Flow Through Cell
Apparatus : 36.5˚-37.5
˚
C, sampling at 45 mins
or as specified,
flowrate ±5%
Coated
Tablet
Basket and Paddle
Apparatus
Extended
Release
--------
IP
USP
EP
(A)Paddle
Apparatus
(B)Basket
Apparatus.
Conditions
same as BP
(A)Basket Apparatus
(B)Paddle Apparatus.
Conditions used for (A)
&(B) are same as in
case for BP
(A)Basket
Apparatus
(B)Paddle
Apparatus
Same conditions for
(A) & (B) as in case
of BP
(C)Flow through
Apparatus:
specifically
intended for
lipophilic solid
dosage forms
such as
suppositories &
soft capsules.
Paddle and
Basket
Apparatus
Basket and Paddle
Apparatus
Basket and Paddle
Apparatus
--------
(A)Basket and Paddle
Apparatus:Time - Test
time points generally
expressed in hours.
Specimens withdrawn
with a tolerance of ±
2% of the stated time
--------
(B) Reciprocating
Cylinder:
(C) Flow through Cell:
Same condition as in
Basket and Paddle
Apparatus
Rectal &
vaginal
-----
------
-----------
Same as solid
dosage form
Dosage form
BP
IP
-----(2)ROTATING CYLINDER
METHOD:
Replace paddle &
shaft. Rotate at
100rpm/min.
Delayed
release Tablet
EP
(1)PADDLE OVER DISK:
Paddle apparatus with SS
Disk Assembly(SSDA)
holding patch at the
bottom of vessel, Temp
32±0.5 ˚C
(1)DISK ASSEMBLY
METHOD:
with addition of
SSDA in form of
a net with an
aperture of 125μ.
Rotate at 100
rpm/min
Transdermal
USP
(2)CYLINDER
APPARATUS:
Similar to Basket
Apparatus except Basket is
replaced by SS stirring
element & maintain temp
32 ± 0.5 ˚C
(3)CELL METHOD:
Rotate at 100
rpm/min .
(3)RECIPROCATING
HOLDER:
Temp 32 ± 0.5 ˚C,
applicable to coated drug
delivery system,
transdermal and other
drug delivery system,
reciprocate at a frequency
of 30 cycles per min with
amplitude of 2 cm or as
specified in monograph,
time as specified
---------
Basket and Paddle
Apparatus :
Time as per individual
monograph. After 2 hours
withdraw sample and
carry out test
--------
 As Per U.S.P. :APPARATUS SUITABILITY TEST :-
 USP REFERENCE STANDARDS FOR APPARATUS –I ,II ,IV & V:
 USP Prednisone Tablet RS
(Dissolution Calibrator ,Disintegrating)
 USP Salicylic acid Tablet RS
(Dissolution Calibrator ,Non-disintegrating)
 USP REFERENCE STANDARDS FOR APPARATUS –III:
 USP Chlorpheniramine Extended-Release Tablets RS
Same as
BP
-------
(Drug Release Calibrator, Single Unit)
 USP Theophylline Extended-Release Beads RS
(Drug Release Calibrator, Multiple Unit)
 FOR BASKET & PADDLE APPARATUS: AS PER USP :FOR NOMINAL
CAPACITY
1L
HEIGHT (mm)
INSIDE DIAMETER
160 to 210
98 to 106 mm
2L
280 to 300
98 to 106 mm
4L
280 to 300
145 to155 mm
 AS PER IP , BP & EP :FOR NOMINAL
CAPACITY
1L
HEIGHT
INSIDE DIAMETER
168 ± 8 mm
98 to 106 mm
 As Per U.S.P. : Basket apparatus is generally used for capsules. Rotated at 100 rpm/min.
 Paddle apparatus is generally used for tablets. Rotated at 50 or 75 rpm/min.
 METHOD OF DEAERATION (USP):
 Heat the medium,while stirring gently to 41˚ C.
 Immediately filter under vaccum using filter having porosity of
0.45 μ or less, with vigrous stirring.
 Continue stirring under vaccum for about 5 min.
 For Conventional Dosage forms:
 AS PER IP , BP , EP ,USP (FOR UNIT SAMPLE):STAGE
NUMBER TESTED
ACCEPTANCE CRITERIA
S1
6
Each Unit NLT Q+ 5%
S2
6
S3
12
Avg. of 12 Units ( S1 + S2 ) is Equal to OR Greater than Q, & No
Unit is less than Q - 15%
Avg. of 24 Units ( S1 + S2 + S3) is Equal to OR Greater than Q,
& NMT 2 Units are LESS than Q - 15%
& No Unit is less than Q - 25%
 AS PER USP (FOR POOLED SAMPLE):STAGE
NUMBER TESTED
S1
6
Avg. AMOUNT DISSOLVED IS NLT Q + 10%
S2
6
S3
12
Avg. AMOUNT DISSOLVED ( S1 + S2 ) IS EQUAL TO OR GREATER
THAN Q + 5%
Avg. AMOUNT DISSOLVED ( S1 + S2 + S3) IS EQUAL TO OR
GREATER THAN Q.

ACCEPTANCE CRITERIA
REFERENCES :
 INDIAN PHARMACOPOEIA -2007, P.NO.:179 to182
 UNITED STATES PHARMACOPOEIA (USP XXVI),
P.NO.:2155 to 2165
 EUROPEAN PHARMACOPOEIA- 5.0, P.NO.:228 to 233
 BRITISH PHARMACOPOEIA-1993, VOL-II,A160