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DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin
  • DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin

DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin

Place of Origin China
Brand Name HS
Certification DMF, GMP, HALAL
Model Number 90%
Product Details
Origin:
Bovine Cartilage
Standard:
USP40
Purity:
≥90%
Apperance:
White To Yellowish Powder
Quality Certificate:
GMP, DMF
Application:
Joint Health
High Light: 

chondroitin sodium sulfate

,

chondroitin sulfate USP

Payment & Shipping Terms
Minimum Order Quantity
50KGS
Price
Negotiable
Packaging Details
25kgs/drum
Delivery Time
5-8 working days
Payment Terms
T/T, L/C
Supply Ability
30 MT/month
Product Description

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 
 
DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin 0
 
 
2016 CPHI SHANGHAI
 
DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP Manufacturer of Chondroitin 1

Contact Us at Any Time

86-573-83025768
No.20 Tongyi Road, Xinfeng Industrial Park, Jiaxing City Zhejiang 314005 China
Send your inquiry directly to us