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Accepted Quality Levels (AQL)
 
SPECIFICATION OF E.H.G. CAPSULES-IP
DESCRIPTION Hard Gelatine Empty Capsules
SIZE As per Empty Hard Shell Capsules, Standard Dimension.(Point 9)
COLOUR The colour of the product should visually match to the sample provided
by the customer, when viewed under normal lighting conditions.
WEIGHT(mg.)
(At 14% moisture)
Size ‘00’ 0’el ‘0’ ‘1’ ‘2’ `3’ ‘4’
  118
±
3
102
±
3
96
±
3
76
±
3
64
±
3
48
±
3
39
±
3
WEIGHT VARIATION The weight of individual capsules should be within ± 10% of the average weight of 100 capsules.
MOISTURE CONTENT 12.5% to 16% (At 105°C for 4 hours)
(Referral test at 105°C for 18 hours)
DISINTEGRATION Maximum 10 minutes (Method followed as in Indian Pharmacopoeia)
MICROBIOLOGICAL LIMITS Total Counts (Max.) – 1000 / gm (As per IP)
E. Coli - Absent / gm (As per IP)
Fungal Counts – 100 /gm (As per IP)
Salmonella – Absent / gm (As per IP)
 
EMPTY HARD SHELL CAPSULES’ STANDARD DIMENSIONS
SIZE ‘00’ SIZE ‘0’el SIZE ‘0’ SIZE ‘1’ SIZE ‘2’ SIZE ‘3’ SIZE ‘4’
Empty Joined Length (mm) 2 5.9
±
0.70
2 5.5
±
0.70
2 3.4
±
0.70
21.1
±
0.70
19.5
±
0.70
17.6
±
0.70
16.2
±
0.70
Cap Length (mm) 11.80
±
0.60
11.38
±
0.60
11.18
±
0.50
10.01
±
0.50
9.17
±
0.50
8.23
±
0.50
7.47
±
0.50
Body Length (mm) 20.20
±
0.60
20.50
±
0.60
18.72
±
0.50
16.72
±
0.50
15.34
±
0.50
13.48
±
0.5
12.34
±
0.5
Cap Diameter (outside) (mm) 8.55
±
0.06
7.63
±
0.06
7.63
±
0.06
6.91
±
0.06
6.34
±
0.06
5.81
±
0.06
5.31
±
0.06
Body Diameter (outside) (mm) 8.22
±
0.06
7.32
±
0.06
7.32
±
0.06
6.62
±
0.06
6.07
±
0.06
5.56
±
0.06
5.06
±
0.06
Cap Thickness
 (D. Wall) (MM)
0.210
±
0.018
0.205
±
0.018
0.205
±
0.018
0.200
±
0.018
0.198
±
0.018
0.196
±
0.018
0.194
±
0.018
Body Thickness
 (D. Wall) (MM)
0.200
±
0.018
0.195
±
0.018
0.195
±
0.18
0.193
±
0.018
0.191
±
0.018
0.188
±
0.018
0.182
±
0.018
Shoulder Thickness (mm) 0.11
±
0.02
0.11
±
0.02
0.11
±
0.02
0.11
±
0.02
0.10
±
0.02
0.10
±
0.02
0.10
±
0.02
Dome Thickness (mm) 0.14
±
0.02
0.14
±
0.02
0.14
±
0.02
0.14
±
0.02
0.14
±
0.02
0.14
±
0.02
0.14
±
0.02
 
 
       
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