(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.

Disintegration1

(G) Apparatus A:

Name of the Apparatus: Basket Rack Assembly.

Specifications:

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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