Disintegration Test for Drugs
(A) Subjective: Procedure for performing Disintegration test.
(B) Purpose: This procedure is applicable for performing dissolution test on drugs used in pharmaceutical company.
(C) Name of the Apparatus: Disintegration Test Basket.
(D) What does Disintegration Test Indicates?
Ans: This test indicates; in which no residue of unit remains on the screen of apparatus. If residue remains, then it indicates that it must be an insoluble coating of Tablet or Capsule shell or a soft mass of Passery or Suppository.
(G) Apparatus A:
Name of the Apparatus: Basket Rack Assembly.
|Six Cylinder Glass Tube||a) Length: 77.5 ± 2.5 mm
b) Inner Diameter: 21.5 mm
c) Wall Thickness: 2 mm
|Two Plastic Plates||a) Diameter: 90 ± 2 mm
b) Thickness: 6.175 ± 1.75 mm
c) Six holes: Diameter same as tubes
|Woven SS Wire Cloth||a) Mesh aperture: 2 ± 0.2 mm
b) Wire diameter: 0.615 ± 0.045 mm
|Raising and lowering of Assembly||At a frequency of 29- 32 cycles/ mint through a distance of 55 ± 2 mm.|
|Disc||a) Diameter: 20.7 ± 0.15 mm
b) Thickness: 9.5 ± 0.15 mm
c) Relative density of plastic: 1.18 to 1.20
d) 5 Pierced holes:
Diameter- 2 mm each
e) One hole in centre and other 4 equally spaced on a circle of radius 6 mm
|Four Grooves||a) Upper Surface: 9.5 mm wide
b) Lower Surface: 1.6 mm wide
c) Deep: 2.5 mm
|Medium||a) Beaker: 1 Litre
b) Wire mesh at highest point at least 15 mm below surface of liquid and at a lower point it is 25 mm above the bottom of beaker
c) Temperature: 37 ± 2 °C
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