Chemcaps Limited

PARAMETER

SPECIFICATION

1.0

DESCRIPTION

Empty Hard Gelatine Capsules consist of low distinct sections -the Cap and the Body. The cap is slipped over the body to complete 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 criteria 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. The solution is neutral or slightly acid. The solution is odourless.

8.0

ARSENIC

Not 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 MICROBIABL AND FUNGAL COUNT

Not more than 500 colonies / grams

13.0

COLIFORMS / SALMONELLA/ E.COLI

Negative