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        1. ENGLISH
          ENGLISH

          明膠膠囊

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

          檢測項/TEST ITEM                                              指標/SPECIFICATIONS

          粘度/Viscosity


          60mm/s

          松緊度/Tightness


          符合規定/Conform

          脆碎度/Friability


          不得超過5/Less than 5 pieces

          崩解時限(min/Disintegration time


          10

          亞硫酸鹽/Sulfite


          0.01%

          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

          鉻(ppm/Chromium


          2


          需氧菌總數(cfu/g/Total bacteria count

          1000

          微生物/Microbial

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

          1g供試品大腸埃希菌/Escherichia coli

          10g供試品沙門菌/Salmonella

          100

          不得檢出/Absent in 1g

          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