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EMPTY
HARD GELATINE CAPSULES SIZES 0,1,2
PARAMETERS, SPECIFICATIONS
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|
PARAMETERS |
SPECIFICATION |
| 1.0 |
DESCRIPTION |
Empty
Hard Gelatine Capsules consist of tow distinct sections
- the Cap and the Body. The cap is slipped over the body
to completely enclose contents. They may come in clear
transparent, coloured-transparent or coloured opaque. |
| 2.0 |
DIMENSION |
Refer
to table of dimensions by size (Table) |
| 3.0 |
WEIGHT |
Refer
to table of capsule weights by size (Table) |
| 4.0 |
COLOUR |
As
specified by product. |
| 5.0 |
ATTRIBUTES |
Shall
pass acceptance criteria based on AQL for critica, major
and minor non-conformities. |
| 6.0 |
LOSS
ON DRYING |
12.5
TO 16.0 % |
| 7.0 |
PURITY |
Soluble
in water within 10 minutes at 37+ 2C. |
| 8.0 |
ARSENIC |
Note
more than 2 ppm. |
| 9.0
|
HEAVY
METALS |
Not
more than 20 PPM |
| 10.0 |
SULFITE |
Not
more than 700 PPM as so. |
| 11.0 |
RESIDUE
ON IGNITION |
Not
more than 4.5% |
| 12.0 |
TOTAL
MICROBIAL AND FUNGAL COUNT |
Not
more than 500 colonies/grams |
| 13.0 |
COLIFORMS/SALMONELLA/E.COLI |
Negative |
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SIZE
# 0 |
SIZE
# 1 |
SIZE
# 2 |
|
MINIMUM
|
MAXIMUM
|
MINIMUM
|
MAXIMUM
|
MINIMUM
|
MAXIMUM
|
| CAP
DIAMETER |
7.57mm
0.298 inches |
7.69mm
0.303 inches |
6.85mm
0.270 inches |
6.97mm
0.274 inches |
6.28mm
0.247 inches |
6.40mm
0.252 inches |
BODY
DIAMETER
|
7.26mm
0.286 |
7.38mm
0.291 |
6.56mm
0.258 |
6.68mm
0.263 |
6.01mm
0.237 |
6.13mm
0.241 |
| CAP
LENGTH |
10.82mm
0.426 |
11.54mm
0.454 inches |
9.65mm
0.380 |
10.37mm
0.408 |
8.81mm
0.347 |
9.53mm
0.375 |
| BODY
LENGTH |
8.36mm
0.723 |
19.08mm
0.751 |
16.36mm
0.644 |
17.08mm
0.672 |
14.98mm
0.590 |
15.70mm
0.618 |
| CAP
DWT. |
0.203mm
0.0080 |
0.223mm
0.0088 |
0.198mm
0.0078 |
0.218mm
0.0086 |
0.185mm
0.0073 |
0.216mm
0.0085 |
BODY
DWT.
|
0.193mm
0.0076
|
0.213mm
0.0084 |
0.189mm
0.0075
|
0.209mm
0.0082 |
0.180mm
0.0071
|
0.211mm
0.0083 |
| AVERAGE
WEIGHT |
97+6
mg |
|
78+5
mg |
|
63+3
mg |
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