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
SIZE # 2
CAP DIAMETER 6.34 + 0.06 mm
BODY DIAMETER
6.07 + 0.06 mm
CAP LENGTH 9.17 + 0.36 mm
BODY LENGTH 15.34 + 0.36 mm
CAP DWT. 0.200 + 0.015 mm
BODY DWT.
0.195 + 0.015 mm
AVERAGE WEIGHT 63 + 10% mg
   
   
   
   
   
   
   
   
   
   
   
   
   
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