PharmaState Is Official Media Partner For DUPHAT 2022. Click the banner to explore more...spot_imgspot_imgspot_img

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.

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

Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. Reproduction and Distribution of the same without written permission is prohibited. Mail us at: info@pharmastate.com

 

For any suggestions & feedback, write to us at info@pharmastate.com

App Link: https://goo.gl/mS8Lr7

Website: https://www.pharmastate.com

PharmaState Blog
This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks.

Share this article

Recent posts

Popular categories

Leave a Reply

Recent comments

Business Alnavedic on History of Indian Pharma Industry
Ahmed Mohamed Elkhodragy on MACO Calculation
Jennifer Osunde on DEFECTS IN UNCOATED TABLETS
Vinod on DEVIATION
Rajib ghose on TOOLING FOR TABLETING
K. SRinivasula Reddy on Quality Agreements – PART 2
Sunil Kumar M on SITE ACCEPTANCE TEST (SAT)
Khalid on IQ Protocol
Khalid on IQ Protocol
Nagabooshanam on Calibration of Reactor
PharmaState Blog on SOP for Sampling
Swapnil Khodake on TOOLING FOR TABLETING
%d bloggers like this: