ENGLISH
ENGLISH

羥丙基甲基纖維素植物膠囊

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

檢測項/TEST ITEM                                              指標/SPECIFICATIONS

崩解時限(min/Disintegration time


10

干燥失重/Loss on drying


12.5%-17.5%

熾灼殘渣/Ignition residue

透明/Transparent

2.0%

著色/Opaque

5.0%

重金屬(ppm/Heavy metal


40

砷(ppm/Arsenic


2

微生物/Microbial

需氧菌總數(cfu/g/Total bacteria count

1000

 

霉菌和酵母菌總數(cfu/g/Total yeast and mold count

100

 

1g供試品大腸埃希菌/Escherichia coli

不得檢出/Absent in 1g

10g供試品沙門菌/Salmonella

不得檢出/Absent in 10g

尺寸和容積/SIZE AND SPECIFICATION

型號

Size

長度

±0.40mm

Length

壁厚±0.02mm

Wall thicknessT

口部外徑(mmOuter diameter

囊重差異(mgWeight diffrence

頂厚(mmDome thicknoss

容積(mlVolume

鎖合長±0.5mmLock length

膠囊裝量參考(依據藥粉密度)(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

±5。0

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


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