| |
PARAMETERS |
|
SPECIFICATION |
| |
|
|
|
| 1.0 |
DESCRIPTION |
|
Empty Hard Gelatine Capsules consist of two
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 critical, 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 |
