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Specifications For Empty Hard Gelatin Capsules

The various quality variants are controlled as per specification prescribed in I.P. 2014.

However our Quality Control norms are even Stringent than those specified in I.P. 2014. We operate under narrower limits for various attributes, like Dimension, Weight etc. than those permitted in I.P. 2014.


DIMENSIONS (in millimeter)
TABLE 1
OUTSIDE DIAMETER
Size CAP (mm) BODY (mm)
#00 8.49 - 8.61 8.16 - 8.28
#0el 7.61 - 7.73 7.30 - 7.42
#0 7.60 - 7.72 7.28 - 7.40
#1 6.87 - 6.99 6.57 - 6.69
#2 6.31 - 6.43 6.02 - 6.14
#3 5.77 - 5.89 5.50 - 5.62
#4 5.27 - 5.39 5.01 - 5.13
#5 4.85 - 4.97 4.59 - 4.71



TABLE 2
LENGTH
Size CAP (mm) BODY (mm)
#00 11.30 - 12.30 19.70 - 20.70
#0el 11.40 - 12.20 19.90 - 20.70
#0 10.20 - 11.20 18.00 - 19.00
#1 9.30 - 10.30 16.10 - 17.10
#2 8.50 - 9.50 14.70 - 15.70
#3 7.60 - 8.60 13.10 - 14.10
#4 6.70 - 7.70 11.70 - 12.70
#5 5.70 - 6.70 8.80 - 9.80


TABLE 3
PRELOCK JOINED LENGTH OF EMPTY SHELLS
Size Prelock Joined Length (mm)
#00 25.40-26.20
#0el 24.32-25.12
#0 23.20-24.0
#1 20.80-21.60
#2 19.02-20.02
#3 17.30-17.90
#4 15.90-16.50
#5 12.70-13.30



TABLE 4
DOUBLE WALL THICKNESS
Size CAP (mm) BODY (mm)
#00 0.190 - 0.250 0.180 - 0.240
#0el 0.188 - 0.224 0.182 - 0.218
#0 0.190 - 0.250 0.180 - 0.240
#1 0.180 - 0.240 0.174 - 0.234
#2 0.180 - 0.240 0.174 - 0.234
#3 0.170 - 0.230 0.164 - 0.224
#4 0.164 - 0.224 0.164 - 0.224
#5 0.164 - 0.224 0.164 - 0.224



TABLE 5
WEIGHT OF CAPSULES (in milligram) & VOLUME (in CC)
AVERAGE WEIGHT (Deviation ± 5%) & VOLUME (in CC)
Size Average weight (mg)
(Avg. of 20 Capsules Taken Together)
Volume (CC)
#00 119 0.95
#0el 104 0.78
#0 96 0.68
#1 76 0.50
#2 63 0.38
#3 50 0.30
#4 40 0.21
#5 28 0.13



TABLE 6
MICROBIOLOGICAL LIMITS
TOTAL COUNTS OF ORGANISM = Less than 1000 / gm
E COLI = NIL (Absent in 1 gm)
SALMONELLA = NIL (Absent in 10 gm)
TESTS AS PRESCRIBED BY IP 2014



TABLE 7
MOISTURE CONTENT AND DISINTEGRATION TIME
MOISTURE CONTENT = 12.5 to 16.0 %
DISNTEGRATION TIME = Less than 15 minutes.





Loss on Drying

Between 12.5 per cent and 16 per cent, determined on capsule shells weighing 1.0 g by drying in an oven at 105° C for 4 hours or to constant weight.

Storage

Capsules should be stored in dry and cool place and boxes should be well closed. The relative humidity is kept between 45 percent and 55 per cent. The temperature should be between 23°C to 27°C.

Filling Performance

We conduct Simulation Test of machine filling for every box of capsules. Our capsules run smoothly on all type of filling machines including Fully Automatic High Speed Filling Machines.

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