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Chondroitin Sulphate Sodium
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| Place of Origin | China |
| Brand Name | HS |
| Certification | DMF，GMP |
| Model Number | USP Standard |
GMP Manufacturer of Bovine Chondroitin Sulfate Sodium , 90% Assay USP Grade with DMF
who we are ?
We are a GMP verified manufacturer of chondroitin sulfate sodium that up to USP40 standards, with DMF documentations in CTD formate.
What does our company ?
Established in 1997, Jiaxing Hengjie Biopharmaceutical Co.,ltd is one of the first chondroitin sulfate manufacturer in china. We have specialized in producing chondroitin sulfate for twenty years.
General introduction about bovine chondroitin sulfate:
Bovine chondroitin sulfate is a type of sulfated mucopolysaccharides extracted from bovine cartilages. It is a hygroscopic powder with white to yellowish color. Reports say that chondroitin sulfate is helpful in repaire the damaged cartilages in joints, thus could relief the pain caused by wear and tear of cartilages in joints. It is commonly used in the production of dietary supplements intended for joints health.
Specification of USP40 grade Bovine chondroitin sulfate sodium :
| 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 | | 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. | ||||||||
Quality Management :
1. The quality Management system of our company is established based on NSF-GMP guidline, and Chinese GMP guidline.
2. We have NSF-GMP for bovine chondroitin sulfate, issued by NSF, updated annually.
3. We have Drug Manufacturer lisence for chondroitin sulfate issued by China FDA, updated every 5 years, valid until October 21th,2017.
4. We have DMF documents in CTD formate for bovine chondroitin sulfate.
5. We have ISO9001 certificate and ISO22000(HACCP) certificate.
6. We have Halal Certificate
We are active in attending the international trade shows including: CPHI, Vitafoods, Supplyside etc.
CPHI 2014 in china, SHANGHAI
Supplyside West 2015 in Las Vegas, USA
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