Technical Specifications
The various quality variants are
controlled as per specification prescribed in I.P. 1996.
However our Quality Control norms are even Stringent than those specified
in I.P. 1996. We operate under narrower limits for various attributes, like
Dimension, Weight etc. than those permitted in I.P. 1996.
| DIMENSIONS (in
millimeter) |
| TABLE 1 |
| OUTSIDE DIAMETER |
| Size |
CAP (mm) |
BODY(mm) |
| #0 |
7.57 - 7.69 |
7.26 - 7.38 |
| #1 |
6.85 - 6.97 |
6.56 - 6.68 |
| #2 |
6.28 - 6.40 |
6.01 - 6.13 |
| TABLE 2 |
| LENGTH |
| Size |
CAP (mm) |
BODY(mm) |
| #0 |
10.88 - 11.48 |
18.42 - 19.02 |
| #1 |
9.71 - 10.31 |
16.42 - 17.02 |
| #2 |
8.87 - 9.47 |
15.04 - 15.64 |
| TABLE 3 |
| PRELOCK JOINED LENGTH OF EMPTY SHELLS |
| Size |
Prelock Joined
Length (mm) |
| #0 |
23.92 24.92 |
| #1 |
20.59 21.59 |
| #2 |
19.02 20.02 |
| TABLE 4 |
| DOUBLE WALL THICKNESS |
| Size |
CAP (mm) |
BODY(mm) |
| #0 |
0.190 - 0.210 |
0.183 - 0.203 |
| #1 |
0.185 - 0.205 |
0.181 - 0.201 |
| #2 |
0.180 - 0.200 |
0.180 - 0.200 |
| TABLE 5 |
| WEIGHT OF CAPSULES (in milligram) &
VOLUME (in CC) |
| AVERAGE WEIGHT (Deviation ± 5%) &
VOLUME (in CC) |
| Size |
Average Weight (mm)
(Avg. of 20 Capsules Taken Together) |
Volume (CC) |
| #0 |
96 |
0.68 |
| #1 |
76 |
0.50 |
| #2 |
63 |
0.38 |
| TABLE 6 |
| MICROBIOLOGICAL LIMITS |
| TOTAL COUNTS OF ORGANISM |
= Less than 1000 / gm |
| E COLI |
= NIL (Absent) |
| SALMONELLA |
= NIL (Absent) |
| TESTS AS PRESCRIBED BY I.P. 1996 |
| TABLE 7 |
| MOISTURE CONTENT AND DISINTEGRATION
TIME |
| MOISTURE CONTENT |
= 13.0 % - 16.0 % |
| DISNTEGRATION TIME |
= Less than 15 minutes. |
Loss on Drying
Between 13 per cent and 16 per cent,
determined on capsule shells weighing 1.0 g by drying in an oven at 105°
for 18 hours.
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 22° C to
28° 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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© Erawat Pharma Limited. All Rights Reserved
