CPC 90% Purity Bovine Chondroitin Sulfate Sodium Verfied by NSF-GMP with Drug Master File DMF
Bovine chondroitin sulfate sodium is a type of Mucopolysaccharides extracted from bovine cartialges, with 90% purity tested by CPC titration method. The bovine cartilages used for the production of chondroitin sulfate sodium are from health animals used for the human consumption. The cartilages are free of BSE/TSE, and Veterinary health certificates are available for each shipment.
The specification of bovine chondroitin sulfate sodium 90% by CPC Titration:
Product: | Chondroitin Sulfate sodium | |||||||
Original | Bovine(Terrestrial) | Report Date | 2017/02/17 | |||||
Batch No.: | HS1702038 | Quantity: | 1000KGS | |||||
Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | |||||
Manufacturing Date: | 2017/02/10 | Expiry Date: | 2019/02/09 | |||||
ITEMS |
SPECIFICATIONS (TEST METHOD) |
RESULT |
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Appearance | White to off-white powder | Pass | ||||||
Identification | Infra Red Confirmed (USP197K). | Pass | ||||||
Sodium reaction (USP191) | Positive | |||||||
The chromatogram of the enzymatically digested sample solution as obtained in the test for the limit of nonspecific disaccharides shows three main peaks corresponding to △DI-4S, △DI-6S,△DI-OS in the enzymatically digested standard solution. By peak area response, △ DI-4S is the most abundant, followed by the △ DI-6S, with △ DI-OS being the least abundant of the three | ||||||||
Assay(ODB) |
NLT90% (CPC Titration) | 91.6% | ||||||
Loss on drying |
Less than12%(USP731) | 8.0% | ||||||
Nonespecific Dissaccharides | NMT10% | 7.2% | ||||||
Protein |
NMT6.0%(USP38) | 4.9% | ||||||
Sulfate |
<0.24%(USP221) | <0.24 | ||||||
Chloride |
<0.5% (USP221) | <0.5% | ||||||
Heavy Metal |
NMT20PPM (Method I USP231) | Pass | ||||||
PH (1%H2O solution) |
5.5-7.5(USP791) | 6.4 | ||||||
Specific Rotation |
- 20°~ -30°(USP781S) | -22.5° | ||||||
Residue on Ignition |
20%-30%(dry base)(USP281) | 25.5% | ||||||
OrganicVolatile Residual(Ethanol) |
NMT0.5% (USP467) | PASS | ||||||
Clarity (5%H2O solution) |
<0.35@420nm | 0.22 | ||||||
Electrophoretic purity | NMT2.0%(USP726) | Pass | ||||||
Bulk Density | NLT 0.5g/ml | Pass | ||||||
Total Bacteria Count |
<1000CFU/g (USP2021) | Pass | ||||||
Yeast & Mold |
<100CFU/g (USP2021) | Pass | ||||||
Salmonella |
Negative (USP2022) | Negative | ||||||
E.Coli |
Negative (USP2022) | Negative | ||||||
Staphylococcus Aureus |
Negative (USP2022) | Negative | ||||||
Enterobacteria |
Negative in 1 gram (USP2022) | Negative | ||||||
Particle size | 100% through 80 mesh | Pass | ||||||
Storage: 25kg/drum, keep in an airtight container, protected from light. |
The benefits of Bovine Chondroitin Sulfate Sodium:
Chondroitin sulfate is a type of Mucopolysaccharides which is commonly found in the tissues of joints in both human and animals. It is considered as the building block for the tissues of human joints. Thus the benefits of chondroitin sulfate are :
1. Help to prevent the breakdow of cartilages in joints.
2. Help increase the fluids in the joints.
3. Relief the pain in the joints.
The application of Bovine Chondroitin Sulfate Sodium:
1. The main application of chondroitin sulfate is joint health dietary supplements including Tablets, Capsules, and powder form.
2. Some bovine chondroitin sulfate is used to produce OTC Drugs in some countries (USA excluded)
3. Bovine chondroitin sulfate could also be used to produce eye drops or Cosmetics.
The Manufacturing Production Flow Chart of bovine chondroitin sulfate:
Bovine Cartilages
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Pre-treatment(cartilages selecting and washing)
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Boiling ( add NACL,boil for 5 hours at the temperature of 90℃)
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Enzymolysis (add pancreatin, add NAOH to adjust the PH value to 8.5-9.0, boil for 6 hours at the temperature of 48℃-50℃
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Flitration
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First sedimentation(add ethanol to dissolve out the crude chondroitin sulfate)
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Hydrolysis (add water and NACL,add NAOH to adjust PH value to about 9.0. Adjust temperature to 48℃-50℃
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Flitration
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Second sedimentation(add ethanol to dissolve out purified chondroitin sulfate
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Dehydration (add ethanol to dehydrate the water out of chondroitin sulfate
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Centrifugation (get rid of ethanol)
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Drying
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Milling and Sifting
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Blending (No other materials are added, just mixing)
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Packing and testing
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Chondroitin sulfate in 25KGS/drum |
The packing and Storage:
1. The packing is 25KG chondroitin sulfate is packed into Double PE bags and put into a fiber drum.
2. The chondroitin sulfate is extremely hygroscopic, avoid exposure to the air when unpacked the original package.
3. Packged into air tight PE bags,put into a fiber drum and then the drum in a cool and dry place, avoid direct sunshine exposure.
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