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Chondroitin Sulphate Sodium
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| Place of Origin | China |
| Brand Name | HS |
| Certification | DMF, GMP, HALAL |
| Model Number | 90% |
DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin
Our company has DMF documentation of chondroitin sulfate in CTD format, we also have GMP certificate.
Jiaxing Hengjie Biopharmaceutical Co.,Ltd. is a GMP manufacturer of bovine chondroitin sulfate with DMF documentation in CTD formate. We have been producing and supplying chondroitin sulfate all around the world for around 20 years, we are specialized and professional in chondroitin sulfate industry.
Our production faclity is GMP verified, plus we have DMF documentation in CTD formate for bovine chondroitin sulfate.
Please check our specification of bovine chondroitin sulfate as below:
| Product: | Chondroitin SULPHATE sodium | |||||||
| Original | Bovine(Terrestrial) | Report Date | 2017/05/20 | |||||
| Batch No.: | HS1705035 | Quantity: | 1000KGS | |||||
| Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | |||||
| Manufacturing Date: | 2017/05/14 | Expiry Date: | 2019/05/13 | |||||
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 | ||||||
| Storage: 25kg/drum, keep in an airtight container, protected from light. | ||||||||
Our quality management system:
1. NSF-GMP. Our comapny had established our quality management system based on NSF-GMP standards.
2. China Drug Manufacturing Lisence. We received the Drug Manufacturing lisence of chondroitin sulfate as API from china FDA. Our company is under the supervision of China FDA.
3. DMF Documentation : We submit our DMF documentation to US FDA, and receive the DMF number from US FDA: 26474.
4. ISO 9001 and ISO22000( HACCP )
5. Halal Certificate: We have Halal Certificate for our bovine chondroitin sulfate.
We attend the trade show all around the world in Foods and API industry.
Below are some of our presence at the show:
2015 CPHI SHANGHAI
2016 CPHI SHANGHAI
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