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Hollow capsule

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%

Drying loss

12.5%~17.5%

14.0%~16.5%

Residue on ignition

Transparent≤2.0%, semi-transparent≤3.0%, 不Transparent≤5.0%

Chrome

≤0.0002%(2.0PPM)

≤0.0001%(1.0PPM)

Heavy metal

≤0.004%

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




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