Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 9057-02-7
- EC No.
- 232-945-1
- Technologies
- Composition of Pullulan Vacant capsules
- Polysaccharides (Poly Maltotriose - Pullulan)
- Purified Water
Features & Benefits
- Labeling Claims
- Advantage of Pullulan Capsules
- not produced by chemical modification, 100% natural
- manufactured by natural fermentation of plant extracts
- neither genetically modified nor pathogenic
- well known in the pharmaceutical and food industry
- non-allergenic
- starch- and gluten-free
- FDA GRAS status
- Non GMO
- kosher halal certificated empty capsule
- 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
- Markets
- Dosage Form
Properties
- Safety of Raw Material
Pullulan Empty Capsules are 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.
Regulatory & Compliance
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
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.