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JIAXING HENGJIE BIOPHARMACEUTICAL CO.,LTD.
Jiaxing Hengjie Biopharmaceutical Co.,Ltd. Professional Chondroitin Sulfate Manufacturer
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DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin

JIAXING HENGJIE BIOPHARMACEUTICAL CO.,LTD.
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DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin

Brand Name : HS
Model Number : 90%
Certification : DMF, GMP, HALAL
Place of Origin : China
MOQ : 50KGS
Price : Negotiable
Payment Terms : T/T, L/C
Supply Ability : 30 MT/month
Delivery Time : 5-8 working days
Packaging Details : 25kgs/drum
Origin : Bovine Cartilage
Standard : USP40
Purity : ≥90%
Apperance : White to yellowish powder
Quality Certificate : GMP, DMF
Application : Joint Health
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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
OriginalBovine(Terrestrial)Report Date2017/05/20
Batch No.:HS1705035Quantity:1000KGS
Net Weight:25KG/DRUMGross weight:27.5KG/DRUM
Manufacturing Date:2017/05/14Expiry Date:2019/05/13

ITEMS


SPECIFICATIONS (TEST METHOD)

RESULT

AppearanceWhite to off-white powderPass
IdentificationInfra 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@420nm0.21
Electrophoretic purityNMT2.0%(USP726)Pass
Bulk DensityNLT 0.5g/mlPass
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 size100% through 80 meshPass
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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DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin Images

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