Pharmaceutical grade Chondroitin Sulfate Sodium 90% Purity Extracted From Bovine CartilagesGMP Manufacturer
Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a GMP Manufacturer of chondroitin sulfate sodium extracted from Bovine cartilages.
Chondroitin sulfate Sodium is mainly used as medicine in the medical treatment of joint disease, and glucosamine used in conjunction with pain, promote cartilage regeneration effect, can improve joint problem fundamentally.
The specification sheet of Bovine Chondroitin Sulfate Sodium by HPLC 90% :
Product: | Chondroitin Sulfate sodium | |||||||
Original | Bovine(Terrestrial) | Report Date | 2019/04/17 | |||||
Batch No.: | HS1904026 | Quantity: | 1000KGS | |||||
Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | |||||
Manufacturing Date: | 2019/04/10 | Expiry Date: | 2021/04/09 | |||||
ITEMS |
SPECIFICATIONS (TEST METHOD) |
RESULT |
||||||
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% (HPLC) | 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. |
Functions of chondroitin sulfate:
1. Rehabilitate the attrited arthrosis cartilage,is a key structural component in cartilage and acts as a lubricant.
2. Enhance the immunity and improve osteoporosis.
3. Cure neuralgia, arthralgia and process the concrescence of wounds.
4. Promote the synthesis of mucopolysaccharides, advance the viscosity of synovia, and improve the metabolism of arthroidal cartilage.
5. Has some curative effect on rheumatoid arthritis and hepatitis.
6. Has some curative effect on melanoma, lung cancer and renal carcinoma.
The advantage of our Bovine Chondroitin Sulfate Sodium :
1. Produced in GMP Workshop, Mircroorganism is strictly controlled, no irradiation is needed.
2. All testing items fully tested by our own Laboratory. We have established an advanced laboratory within our factory, which is able to perform all the testing items listed above.
3. NSF-GMP Quality Mangement system. Our company is NSF-GMP qualified since 2012/
4. HACCP: Our bovine chondroitin sulfate is HACCP verified.
5. Drug Master File Available. The US DMF # of chondroitin sulfate is : 26474.
The documentation is available in CTD Format.
6. Drug Manufacturing Lisence from China FDA. Our company has the Drug Manufacturing Lisence for chondroitin sulfate as API from China FDA.
Free Sample you can get:
Free sample of less than 150gram is available for testing upone request.
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