GMP of Chondroitin Sulfate Bovine Sodium 90% USP Grade / DMF Documentation Available

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GMP Manufacturer of Bovine Chondroitin Sulfate Sodium 90% USP Grade / DMF Documentation Available Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a GMP Verified manufacturer of bovine chondroitin sulfate sodium with DMF documentation available. Founded in 1997, Our company is one of the first chondroitin sulfate manufacturers in china, we are professional in chondroitin sulfate production and supplying. Bovine Chondroitin sulfate sodium is extracted from the bovine cartilages with 90% content of chondroitin sulfate sodium by CPC Titration method, which conform to USP Standards. The Specification of Bovine Chondroitin Sulfate Sodium - - - - Product: | Chondroitin Sulfate Sodium | Original | Bovine(Terrestrial) | Report Date | 2017/06/19 | Batch No.: | HS1706028 | Quantity: | 1000KGS | Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | Manufacturing Date: | 2017/06/13 | Expiry Date: | 2019/06/12 | TESTING 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% (CPC) | 91.2% | Loss on drying | Less than12%(USP731) | 8.6% | Protein | NMT6.0%(USP38) | 4.8% | 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) | 6.3 | Specific Rotation | - 20~ -30(USP781S) | -23.5 | Residue on Ignition | 20%-30%(dry base)(USP281) | 24.5% | OrganicVolatile Residual(Ethanol) | NMT0.5% (USP467) | PASS | Clarity (5%H2O solution) | <0.35@420nm | 0.21 | 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 | Conform to USP39 standards | Storage: 25kg/drum, keep in an airtight container, protected from light. | - - - - Our company has a higer standard of quality management than other manufacturer of chondroitin. Please see the below Quality Management system of our company: 1. NSF-GMP Verified Our production facilityis NSF-GMP verified since the year of 2012 2. ISO 9001/ ISO22000 Our company is ISO9001 verfied and pass the ISO22000 which is HACCP. 3. DMF dcoumentaion and DMF number are avaliable. Our company has the US DMF number for chondroitin sulfate sodium: #26474. EU DMF documentation for chondroitin sulfate are also available. 4. Halal Certificate: We have the Halal Certificate for the Bovine Chondroitin Sulfate Sodium. 5. Japan Foreign Drug Manufacture Registration Free Samples of chondroitin sulfate and working standard are available upon request. If you have any questions, please feel free to contact us.

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JIAXING HENGJIE BIOPHARMACEUTICAL COMPANY

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