(A) Subjective:  Procedure for performing Friability test on Tablets.

(B) Purpose: This procedure is applicable for friability test on tablets and calibration of friabilator used in pharmaceutical company.

(C) Name of the Apparatus: Friabilator.

(D) Significance of Friability Test: This test is intended to determine the Physical Strength of the Tablet.

(E) Description of Apparatus:

(a) Design of Friabilator:

Frialibility1

(b) Apparatus:

                     Specifications                                Description
Drum It is made up of Transparent Synthetic Polymer.

Diameter: 283- 291 mm

Depth: 36- 40 mm

Curved Projection Inner Radius: 75.5- 85.5 mm

It enables tumbling of tablets at each turn of Drum.

Drum Height                                  156 ± 2 mm

Or

6 inches

 Drum Rotation 25 ± 1 rpm

 

(F) Procedure of Friability Apparatus:

For tablet with an average weight of 0.65g or less; a sample of whole tablet correspond to 6.5g should be taken.

For tablet with an average weight of more than 0.65g; then take sample of 10 whole tablets.

Friability 2

Result: A maximum loss of weight not greater than 1% is acceptable.

Note: If size or shape of tablets causes irregular tumbling then adjust drum base so that it form an angle of about 10 degree with horizontal.

(G) Calibration of Friabilator:

             (a) Calibration of RPFriability 3

 

                (b) Calibration of timer

Friability 4

                                     (c) Calibration of Number of Counts

Friability 5

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