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Genex Bio-Tech USA Vegetable Capsule Pullulan Hard Capsule

Vegetable Capsule Pullulan Hard Capsuleare made of pullulan polysaccharide and auxiliary materials. Pullulan polysaccharide is a kind of water-soluble mucopolysaccharide, which features filming, fibration, gas barrier, bonding, easy processing, non-toxic. 2007, pullulan empty hard capsules were developed successfully by our own technicians and the technology is tested to be advanced during last ten years.

Chemical Name: Pullulan

Functions: Capsule

Labeling Claims: Halal, Kosher, Vegetarian

Certifications & Compliance: GMP, Halal, ISO 9001, Kosher

Dosage Form: Capsules

    Knowde Enhanced TDS

    Identification & Functionality

    Chemical Name
    Pharma & Nutraceuticals Functions
    CAS No.
    9057-02-7
    EC No.
    232-945-1
    Capsule Color Support

    We can help your product stand out and reinforce your brand image.  Color is a key aspect of any product’s marketing strategy, so capsules can be manufactured to your existing color specifications.

    Features & Benefits

    Product Features
    • Fermentation of pure natural plant without chemical additives
    • Low oxygen permeability, easy to store.
    • With no pathogenic factors, such as mad cow disease, SARS, H1N1.
    • No cross linking reaction.
    • The pullulan capsules have relatively stable rate of drug release and differ slightly in size.

    Applications & Uses

    Dosage Form

    Regulatory & Compliance

    Certifications & Compliance
    Certifications
    • FDA
    • CFDA
    • Halal
    • kosher
    • ISO9001

    Technical Details & Test Data

    Test Results
    ITEM STANDARD RESULTS
    Length (m/m)

    Cap - 10.6 - 11.4

    Body - 18.2 - 19.0

    11.00

    18.50

    Weight (mg) 85.5 - 104.5 100.00
    Heavy Metal (ppm Pb) Less than 40 Passed
    Loss in Drying 3 - 7% Passed
    Disintegration (minute) Within 20 minutes Passed
    Arsenic (ppm As) Less than 3ppm Passed
    Residue on Ignition (%) Less than 3% Passed
    Bacteria; Count (col/g) Less than 500 Passed
    Yeast/Mold (col/g) Less than 100 Passed
    E. Coli(-/10g) Negative Passed
    Salmonella(-/10g) Negative Passed
    Staphylococcus aureus(-/10g) Negative Passed
    Pseudomonas aeruginosa(-/10g) Negative Passed

    Packaging & Availability

    Packaging

    Filling Capacity:

    Filling Capacity
    Size #00E #00 #0 #1 #2 #3 #4
    Volume(ml) 1.04 0.95 0.68 0.50 0.37 0.30 0.21
    Capacity(mg) 0.8 g/cc 832 760 544 400 296 240 168
    1.0 g/cc 1040 950 680 500 370 300 210
    1.2 g/cc 1248 1140 816 600 444 360 252

     

    Packing Specification:

    Carton Count
    Size Quantity
    00 85,000
    0 110,000
    1 150,000
    2 200,000

     

    Carton Demension

    L= cm 55 L = inches 21.65
    W = cm 50 W = inches 19.69
    H = cm 71 H = inches 27.95
    Cubic cm 195,250.00 Cubic in 11,914.89
    • 12 Boxes per pallet
    Printing

    Printed words or logo on capsules are available.

    Storage & Handling

    How To Store Capsule Shell?
    • Hollow capsule has too little moisture easily crazing, too much moisture easily to be soft and deform. So the vacant capsule water moisture should be controlled between 12.5 to17.5% when they were stored.
    • Cannot be placed at random, and cannot give it pressure.
    • The container should be kept sealed before used if it was opened, please take the corresponding sterilization measures, otherwise easy to cause bacterial contamination.
    • Storage temperature should be kept in 15 to 25 ℃; Keep in 35-65% relative humidity.
    • Do not store in high temperature and high humidity condition. Under heat condition, it will be soft , adhesion and deformation .Under low temperature or dry environment, the capsule is easy to crazing .

    Do as above mentioned conditions to store capsule , the capsule can be well stored more than 9 months.