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

Conditions used for (A) &(B) are same as in case for BP Coated Tablet Paddle and Basket Apparatus Basket and Paddle Apparatus (A)Basket and Paddle Apparatus:Time . pH ±0. speed ±5%.Dosage form BP (A)Basket Apparatus (B)Paddle Apparatus For (A) & (B) use 1000ml vessel. Conditions same as BP (A)Basket Apparatus (B)Paddle Apparatus.Test time points generally expressed in hours. 36.05 unit. 25±2mm distance between lowest point of vessel and lowest point of rotating element. Basket and Paddle Apparatus Uncoated tablet (A)Paddle Apparatus (B)Basket Apparatus.5 ˚ C. flowrate ±5% Basket and Paddle Apparatus IP USP EP (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specifically intended for lipophilic solid dosage forms such as suppositories & soft capsules.5˚-37.7˚C. Specimens withdrawn with a tolerance of ± 2% of the stated time (B) Reciprocating Cylinder: (C) Flow through Cell: Same condition as in Basket and Paddle Apparatus Extended Release -------- -------- -------- Rectal & vaginal ----- ------ ----------- Same as solid dosage form .5˚37. sampling at 45 mins or as specified. (C)Flow Through Cell Apparatus : 36.

Rotate at 100 rpm/min Transdermal (2)ROTATING CYLINDER METHOD: Replace paddle & shaft. Rotate at 100rpm/min.Disintegrating)  USP Salicylic acid Tablet RS (Dissolution Calibrator . time as specified Basket and Paddle Apparatus : Time as per individual monograph.Dosage form BP IP USP (1)PADDLE OVER DISK: Paddle apparatus with SS Disk Assembly(SSDA) holding patch at the bottom of vessel.II . Temp 32±0. transdermal and other drug delivery system. applicable to coated drug delivery system. :APPARATUS SUITABILITY TEST :-  USP REFERENCE STANDARDS FOR APPARATUS –I .S. (3)CELL METHOD: Rotate at 100 rpm/min . After 2 hours withdraw sample and carry out test EP (1)DISK ASSEMBLY METHOD: with addition of SSDA in form of a net with an aperture of 125μ.5 ˚C.5 ˚C (2)CYLINDER APPARATUS: Similar to Basket Apparatus except Basket is replaced by SS stirring element & maintain temp 32 ± 0.Non-disintegrating)  USP REFERENCE STANDARDS FOR APPARATUS –III:  USP Chlorpheniramine Extended-Release Tablets RS . ------ Same as BP Delayed release Tablet --------- -------- -------  As Per U.IV & V:  USP Prednisone Tablet RS (Dissolution Calibrator .P.5 ˚C (3)RECIPROCATING HOLDER: Temp 32 ± 0. reciprocate at a frequency of 30 cycles per min with amplitude of 2 cm or as specified in monograph.

S.15% & No Unit is less than Q . with vigrous stirring. : Basket apparatus is generally used for capsules. EP . of 24 Units ( S1 + S2 + S3) is Equal to OR Greater than Q.while stirring gently to 41˚ C. Rotated at 100 rpm/min. Rotated at 50 or 75 rpm/min. & No Unit is less than Q .USP (FOR UNIT SAMPLE):STAGE S1 S2 S3 NUMBER TESTED 6 6 12 Each Unit NLT Q+ 5% Avg.  Continue stirring under vaccum for about 5 min. BP & EP :FOR NOMINAL CAPACITY 1L HEIGHT 168 ± 8 mm INSIDE DIAMETER 98 to 106 mm  As Per U.(Drug Release Calibrator. BP .15% Avg.  For Conventional Dosage forms:  AS PER IP .P.25% ACCEPTANCE CRITERIA .  METHOD OF DEAERATION (USP):  Heat the medium. & NMT 2 Units are LESS than Q . Single Unit)  USP Theophylline Extended-Release Beads RS (Drug Release Calibrator.  Immediately filter under vaccum using filter having porosity of 0. of 12 Units ( S1 + S2 ) is Equal to OR Greater than Q. Multiple Unit)  FOR BASKET & PADDLE APPARATUS: AS PER USP :FOR NOMINAL CAPACITY 1L 2L 4L HEIGHT (mm) 160 to 210 280 to 300 280 to 300 INSIDE DIAMETER 98 to 106 mm 98 to 106 mm 145 to155 mm  AS PER IP .  Paddle apparatus is generally used for tablets.45 μ or less.

A160 . AS PER USP (FOR POOLED SAMPLE):STAGE S1 S2 S3 NUMBER TESTED 6 6 12 ACCEPTANCE CRITERIA Avg.0.5. P.NO.NO. VOL-II.NO. P.  REFERENCES :  INDIAN PHARMACOPOEIA -2007.:179 to182  UNITED STATES PHARMACOPOEIA (USP XXVI).:228 to 233  BRITISH PHARMACOPOEIA-1993. 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. P. AMOUNT DISSOLVED IS NLT Q + 10% Avg.:2155 to 2165  EUROPEAN PHARMACOPOEIA.