ENGLISH
ENGLISH

明胶胶囊

理化和微生物指标/PHYSICOCHEMICAL AND MICROBIAL INDEX

检测项/TEST ITEM                                              指标/SPECIFICATIONS

粘度/Viscosity


60mm/s

松紧度/Tightness


符合规定/Conform

脆碎度/Friability


不得超过5/Less than 5 pieces

崩解时限(min/Disintegration time


10

亚硫酸盐/Sulfite


0.01%

干燥失重/Loss on drying


12.5%-17.5%

炽灼残渣/Ignition residue

透明/Transparent

2.0%

着色/Opaque

5.0%

重金属(ppm/Heavy metal


40

铭(ppm/Chromium


2


需氧菌总数(cfu/g/Total bacteria count

1000

微生物/Microbial

霉菌和酵母菌总数(cfu/g/Total yeast and mold count

1g供试品大肠埃希菌/Escherichia coli

10g供试品沙门菌/Salmonella

100

不得检出/Absent in 1g

不得检出/Absent in 10g

尺寸和容积/SIZE AND SPECIFICATION

型号

Size

长度

±0.40mm

Length

壁厚±0.02mm

Wall thicknessT

口部外径(mmOuter diameter

囊重差异(mgWeight diffrence

顶厚(mmDome thicknoss

容积(mlVolume

锁合长±0.5mmLock length

胶囊装量参考(依据药粉密度)(mgWeight lapacity

00#el

/cap

12.80

0.115

8.50-8.60

±10.0

0.12

1.0

25.3

600

800

1000

1200

/body

21.90

0.110

8.15-8.25

00#

/cap

11.80

0.115

8.50-8.60

±8.0

0.12

0.93

23.4

558

744

930

1116

/body

20.10

0.110

8.15-8.25

0#el

/cap

11.80

0.110

7.64-7.74

±7.0

0.12

0.74

23.4

444

592

740

888

/body

20.20

0.105

7.31-7.41

0#

/cap

11.00

0.110

7.61-7.71

±7.0

0.12

0.68

21.7

408

544

680

816

/body

18.60

0.105

7.30-7.40

1#

/cap

9.90

0.105

6.90-7.00

±6.0

0.12

0.50

19.3

300

400

500

600

/body

16.50

0.100

6.61-6.69

2#

/cap

9.00

0.095

6.32-6.40

±50

0.12

0.37

17.8

222

296

370

444

/body

15.40

0.095

6.05-6.13

3#

/cap

8.10

0.090

5.79-5.87

±4.0

0.12

0.30

15.7

180

240

300

360

/body

13.60

0.090

5.53-5.61

4#

/cap

7.20

0.090

5.28-5.36

±3.0

0.12

0.21

14.2

126

168

210

252

/body

12.20

0.85

5.00-5.08

5#

/cap

6.40

0.090

4.87-4.95

±3.0

0.12

0.12

11.2

72

96

120

144

/body

9.20

0.085

4.56-4.64

A#

/cap

14.40

0.105

8.50-8.60

±7.0

0.12

0.68

17.9

408

544

680

816

/body

18.40

0.105

8.15-8.25

B#

/cap

11.00

0.105

8.50-8.60

±6.0

0.12

0.50

14.6

300

400

500

600

/body

11.30

0.105

8.15-8.25