1)Specification: bnb
Place of origin:China
Material:pharmaceutical grade gelatine
Size: 00# 0# 1# 2# 3# 4#
Application:As the packaging for medicine powder;medicine granule;medicine pellet;herbal medicine powder etc.
3) Product storage
Capsule storage should be in sealed, a cool and dry place, cleaning, preservation, stacking shall not exceed three layers, the ideal storage temperature for 15 to 25 , relative humidity is 35% - 65%, capsule under high temperature, low cold, heat, sunlight and water environment.
4 ). The Chemical Specifications of (ChinaPharmacopoeia 2010 the second edition )
Identification: Shall be positive
Elastic Tightness: Less than 2PC
Friability: Less than 15PCS
Disintegration Time: No more than 10 Minutes
Sulphite: Shall comply to stipulations
Ethylene oxide: For the sample solotio of ethylene chlorohydrin in peak area should less than the control solution of the peak area
Ethylene Chlorohydrin: For the sample solotio of ethylene exide in peak area should less than the control solution of the peak area
Chromium: no more than 2ppm
Loss on Drying: 12.5-17.5%
Residue on Ignition(%):Transparent No more than 2
Translucent No more than 3
Opaque No more than 5
Heavy Metals(PPM Pb): No more than 40
Viscosity(mm2/S): No less than 60
Micro-Organism: Total count of Bacilus: No more than1000 unit/g
Total count of Mildew: No more than 100unit/g
Total count of Escherichia : Should not be detected
2) The Physical Specifications:
|
|
00 |
0 |
1 |
2 |
3 |
4 |
|
Caplength (mm) |
11.6±0.4 |
10.8±0.4 |
9.8±0.4 |
9.0±0.3 |
8.1±0.3 |
7.1±0.3 |
|
Bodylength (mm) |
19.8±0.4 |
18.4±0.4 |
16.4±0.4 |
15.4±0.3 |
13.4±0.3 |
12.1±0.3 |
|
Cap.outer diameter(mm |
8.48±0.03 |
7.58±0.03 |
6.82±0.03 |
6.35±0.03 |
5.86±0.03 |
5.33±0.03 |
|
Body outer diameter(mm |
8.15±0.03 |
7.34±0.03 |
6.61±0.03 |
6.07±0.03 |
5.59±0.03 |
5.06±0.03 |
|
Locked length (mm) |
23.3±0.3 |
21.2±0.3 |
19±0.3 |
17.5±0.3 |
15.5±0.3 |
13.9±3 |
|
The average weight(mg) |
122±10 |
97±8 |
77±6 |
62±5 |
49±4 |
39±0.3 |
|
Volume (ml) |
0.95 |
0.68 |
0.50 |
0.37 |
0.30 |
0.21 |
|
Powder density and typical filling weight (mg) |
||||||
|
0.66g/ml |
570 |
408 |
300 |
222 |
180 |
126 |
|
0.8g/ml |
760 |
544 |
400 |
296 |
240 |
168 |
|
1.0g/ml |
950 |
680 |
500 |
370 |
300 |
210 |
|
1.2g/ml |
1140 |
816 |
600 |
444 |
360 |
252 |