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  • 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

    铬(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