Dimensional
Specification:
The
following specifications apply to Capsugel hard gelatin capsules.
Weight:
The
average capsule weight of an order is estimated by a representative sample
average of 100 capsules falling within the limits given bellow:
(values in mg
for one capsules)
Size
|
Target (mg)
|
Limits (mg)
|
000
|
163
|
150 – 176
|
00
|
122
|
112 – 132
|
0
el
|
112
|
103 – 121
|
0
|
96
|
86 – 105
|
1
|
77
|
69 – 85
|
2
|
62
|
56 – 68
|
3
|
49
|
44 – 54
|
4
|
39
|
36 – 44
|
5
|
27
|
24 - 36
|
A moisture
content of 14% to 14.5% is assumed upper and lower limits are given at the
99.9% confidence level.
In
empty hard gelatin capsule production wall thickness is carefully monitored and
controlled by the regulation of gelatin solution viscosity. However, since the
physical properties of raw gelatin are not constant. Solution density may vary
and affect the resultant capsule weight. Therefore the above target weight
should not be used as tare weights in capsule filling samples from the actual
batch being filled should be taken as tare weights.
Capsule capacity:
The average capsule volume and filled capsule weight
capacity for typical powder dose densities is as follows:
Capsule
Size
|
Capsule Volume ML of Water
|
Capsule weight capacity in mg
|
|||
Powder dose density
|
|||||
0.6 g/cc
|
0.8 g/cc
|
1.0 g/cc
|
1.2 g/cc
|
||
000
|
1.37
|
822
|
1096
|
1370
|
1644
|
00
|
0.95
|
520
|
760
|
950
|
1140
|
0
el
|
0.78
|
458
|
624
|
780
|
936
|
0
|
0.68
|
408
|
544
|
680
|
816
|
1
|
0.50
|
300
|
400
|
500
|
600
|
2
|
0.37
|
222
|
296
|
370
|
444
|
3
|
0.30
|
180
|
240
|
300
|
360
|
4
|
0.21
|
126
|
168
|
210
|
252
|
5
|
0.13
|
78
|
104
|
130
|
156
|
The above data are to be considered as
approximations since filling product variables and filling machine type can
significantly affect the capsule weight capacity.
Daniela Camara.
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