Chondroitin Sulfate Sodium Extracted from Marine Cartilages by GMP Manufacturer with Competitive Price
Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a manufacturer of marine chondroitin sulfate sodium extracted from the marine cartilages. The product is of white or yellowish flowing powder, and contain 90% chondroitin sulfate by the CPC or HPLC testing method. The material is hygroscopic powder once dried, preserved in air tight container, avoid exposure to the air, protect from light.
Why choose our company ?
The advantages of our marine chondroitin sulfate sodium :
1. GMP Certificates: Our production facility is GMP verified
2. None Irradiated : Production is done is GMP workshop, bacteria is well controlled, no irradiation is needed.
3. Laboratory testing: We established our own laboratory in company, and we can do all the testing items listed in above specification sheet.
4. MSC Certificate. We have the MSC certificate for our Marine chondroitin Sulfate sodium.
5. Founded in 1997, 20 years history in chondroitin sulfate industry.
6. Wordwide presence. We have branch company in San Diego, USA, with warehouse and sales Team.
Below is the specification sheet of Marine Chondroitin Sulfate
Product: | Chondroitin Sulfate sodium | |||||||
Original | Marine | Report Date | 2017/01/14 | |||||
Batch No.: | HS1701023 | Quantity: | 1000KGS | |||||
Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | |||||
Manufacturing Date: | 2017/01/09 | Expiry Date: | 2019/01/08 | |||||
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) | 91.3% | ||||||
Loss on drying |
Less than12%(USP731) | 8.2% | ||||||
Nonespecific Dissaccharides | NMT10% | 7.3% | ||||||
Protein |
NMT6.0%(USP38) | 4.7% | ||||||
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) | 6.5 | ||||||
Specific Rotation |
- 12°~ -20°(USP781S) | -17.5° | ||||||
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 |
Marine 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
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