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URL: http://www.alkpharm.com
Hollow capsule
Item |
Requirements in the Chinese Pharmacopoeia 2015 Edition |
Internal control standard |
|
Properties |
This product has a cylindrical shape and is a hard and elastic hollow sac composed of two caps and body parts that can be fitted and locked. The capsule should be smooth, uniform in color, smooth in cut, no deformation, no odor. This product is transparent (both sections do not contain sunscreen), translucent (only one section contains sunscreen), opaque (both sections contain masking agents). |
||
Identification |
(1)(2)(3)Identification reaction should be positive |
||
Inspection
|
Viscosity |
≥60mm2/s |
≥65mm2/s |
Tightness |
Bonding, deforming or cracking are not allowed; the powder leakage may not more than 1 grain/10 granules. |
||
Brittleness |
Rupture is no more than 5 capsules of 50. |
||
Disintegration time limited |
Completely dissolve or disintegrate within 10 minutes |
Completely dissolve within 10 minutes |
|
Sulfite |
(as SO2)≤0.01% |
||
Parabens |
No more than 0.05% |
Do not use this process |
|
Chlorohydrin |
Should comply with the regulations |
||
Ethylene oxide |
≤0.0001% |
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Drying loss |
12.5%~17.5% |
14.0%~16.5% |
|
Residue on ignition |
Transparent≤2.0%, semi-transparent≤3.0%, 不Transparent≤5.0% |
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Chrome |
≤0.0002%(2.0PPM) |
≤0.0001%(1.0PPM) |
|
Heavy metal |
≤0.004% |
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Microbial limit |
Aerobic bacteria ≤1000cfu/g Mold, yeast ≤100 cfu /g |
Aerobic bacteria ≤500cfu/g Mold, yeast ≤50 cfu /g |
|
Escherichia coli Not allowed/ g Salmonella Not allowed/10g |
Escherichia coli Not allowed/ g Salmonella Not allowed/10g |
Model
|
Length mm) |
Single wall thickness (mm) |
Evenness (mm) |
Top thickness (mm) |
Shoulder thickness (mm) |
Pre-fit (mm) |
Socket length (mm) |
Grain weight (mg ) |
Volume (ml) |
00#Cap
|
17.00±0.20 20.20±0.20 |
0.120±0.010 0.115±0.010 |
0.010
|
0.13~0.20 |
0.09~0.12 |
25.50±0.50 |
23.30±0.30 |
122±8 |
0.95 |
0#Cap
|
11.00±0.20 18.50±0.20 |
0.110±0.010 0.110±0.010 |
0.13~0.20 |
0.09~0.11 |
23.50±0.50 |
21.20±0.30 |
102±7 |
0.68 |
|
0#Cap
|
11.00±0.20 20.40±0.20 |
0.110±0.010 0.110±0.010 |
0.13~0.20 |
0.09~0.11 |
25.20±0.50 |
23.20±0.30 |
105±7 |
0.78 |
|
1#Cap
|
9.80±0.20 16.50±0.20 |
0.100±0.008 0.100±0.008 |
0.13~0.18 |
0.09~0.11 |
21.00±0.50 |
19.00±0.30 |
78±6 |
0.50 |
|
2#Cap
|
9.00±0.20 15.40±0.20 |
0.095±0.006 0.090±0.006 |
0.12~0.18 |
0.08~0.10 |
19.30±0.40 |
17.50±0.30 |
63±5 |
0.37 |
|
3#Cap |
8.00±0.20 13.50±0.20 |
0.090±0.005 0.080±0.005 |
0.12~0.17 |
0.08~0.10 |
16.60±0.40 |
15.30±0.30 |
47±4 |
0.30 |
|
4#Cap |
7.20±0.20 12.20±0.20 |
0.080±0.005 0.075±0.005 |
|
0.11~0.17 |
0.07~0.10 |
15.50±0.40 |
13.90±0.30 |
39±3 |
0.21 |