(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:
|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
|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.
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 RP
(b) Calibration of timer
(c) Calibration of Number of Counts
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