Comparison of various disssolution

specification as per IP/ BP/ USP/ EP

Dosage form BP IP USP EP

(A)Basket Apparatus (A)Basket

(B)Paddle Apparatus Apparatus
For (A) & (B) use
(B)Paddle
1000ml vessel, 36.5-
Apparatus
37.7C, pH 0.05 unit,
(A)Paddle Same conditions for
speed 5%, 252mm (A)Basket Apparatus (A) & (B) as in case
Apparatus
distance between (B)Paddle Apparatus. of BP
Uncoated lowest point of vessel (B)Basket
Conditions used for (A) (C)Flow through
tablet Apparatus. Apparatus:
and lowest point of &(B) are same as in
Conditions specifically
rotating element. case for BP
same as BP intended for
(C)Flow Through Cell
lipophilic solid
Apparatus : 36.5-37.5 dosage forms

C, sampling at 45 mins such as
or as specified, suppositories &
flowrate 5% soft capsules.
Paddle and
Coated Basket and Paddle Basket and Paddle Basket and Paddle
Basket
Tablet Apparatus Apparatus Apparatus
Apparatus

(A)Basket and Paddle

Apparatus:Time - Test
time points generally
expressed in hours.
Specimens withdrawn
with a tolerance of
Extended 2% of the stated time
-------- -------- --------
Release
(B) Reciprocating
Cylinder:

(C) Flow through Cell:

Same condition as in
Basket and Paddle
Apparatus

Rectal & Same as solid

----- ------ -----------
vaginal dosage form
Dosage form BP IP USP EP

(1)PADDLE OVER DISK:

Paddle apparatus with SS
Disk Assembly(SSDA)
holding patch at the
bottom of vessel, Temp
(1)DISK ASSEMBLY
320.5 C
METHOD:
with addition of
(2)CYLINDER
SSDA in form of
APPARATUS:
a net with an
Similar to Basket
aperture of 125.
Apparatus except Basket is
Rotate at 100
replaced by SS stirring
rpm/min
element & maintain temp Same as
Transdermal ------ 32 0.5 C
(2)ROTATING CYLINDER BP
METHOD:
(3)RECIPROCATING
Replace paddle &
HOLDER:
shaft. Rotate at
Temp 32 0.5 C,
100rpm/min.
applicable to coated drug
delivery system,
(3)CELL METHOD:
transdermal and other
Rotate at 100
drug delivery system,
rpm/min .
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 :
Delayed Time as per individual
--------- -------- -------
release Tablet 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
 (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 HEIGHT (mm) INSIDE DIAMETER
CAPACITY
1L 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 HEIGHT INSIDE DIAMETER
CAPACITY
1L 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 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 Avg. of 12 Units ( S1 + S2 ) is Equal to OR Greater than Q, & No
Unit is less than Q - 15%
S3 12 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 ACCEPTANCE CRITERIA

S1 6 Avg. AMOUNT DISSOLVED IS NLT Q + 10%

S2 6 Avg. AMOUNT DISSOLVED ( S1 + S2 ) IS EQUAL TO OR GREATER

THAN Q + 5%
S3 12 Avg. AMOUNT DISSOLVED ( S1 + S2 + S3) IS EQUAL TO OR
GREATER THAN Q.

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