COMPRESSION PARAMETERS START UP & INPROCESS

Sr Parameter Standa No of In-

. rd Tablets Process
N Frequenc
o y
1 Temperature (37.0±0.5)C˚ - 2
- hours
2 Relative humidity NMT 22% - 2
- hours
3 Hydraulic Pressure 20 kN/cm2 compression pressure - --
tablet press machine -

4 Machine speed 30 rpm compression speed - --

-
5 Punch size a 12 mm flat-faced punch All stations --
6 Description A White to off - white colored All station 2
hours
oval shaped biconvex uncoated
tablet.
7 Average- length 21.8 – 22.2 mm 6 / Individual 2
hours
8 Average -width 9.4 – 9.6 mm 6 / Individual 2
hours
9 Thickness 12 to 12.1 mm 6 / Individual 30
Min.
10 Hardness 7.06±0.23 Kg/cm2 6 / Individual 30
Min.
11 Disintegration time NMT 12 minutes 6/ 2
Composite hours
12 Friability NMT 1 % w/w 10/ 2
Composite hours
13 Weight of 20 tabs. 10 g ± 3% 20/ 15
Composite Min
14 Uniformity of weight NMT 2 tablets in 20 deviate 20/
from the average weight by Composite
2
more than
Hour
5% No tablet deviates from the
average weight by more than 10
%.
Average weight
15 500 mg ± 3% 20/ 15
of tablets
Composite Min
16 Lower weight Should be satisfactory - ---
assembly -
-