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JIAXING HENGJIE BIOPHARMACEUTICAL CO.,LTD.

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Address: No.20 Tongyi Road, Xinfeng Industrial Park, Jiaxing City Zhejiang 314005 China

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Product Details

Chondroitin Sulfate Sodium Extracted from Marine Cartilages by GMP Manufacturer with Competitive Price

 

Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a manufacturer of marine chondroitin sulfate sodium extracted from the marine cartilages. The product is of white or yellowish flowing powder, and contain 90% chondroitin sulfate by the CPC or HPLC testing method. The material is hygroscopic powder once dried, preserved in air tight container, avoid exposure to the air, protect from light.

 

 

Why choose our company ?

 

The advantages of our marine chondroitin sulfate sodium :

 

 

1. GMP Certificates: Our production facility is GMP verified

 

2. None Irradiated : Production is done is GMP workshop, bacteria is well controlled, no irradiation is needed.

 

3. Laboratory testing: We established our own laboratory in company, and we can do all the testing items listed in above specification sheet.

 

4. MSC Certificate. We have the MSC certificate for our Marine chondroitin Sulfate sodium.

 

5. Founded in 1997, 20 years history in chondroitin sulfate industry.

 

6. Wordwide presence. We have branch company in San Diego, USA, with warehouse and sales Team.

 

 

Below is the specification sheet of Marine Chondroitin Sulfate 

 

 

Product:Chondroitin Sulfate sodium
OriginalMarine Report Date2017/01/14
Batch No.:HS1701023Quantity:1000KGS
Net Weight:25KG/DRUMGross weight:27.5KG/DRUM
Manufacturing Date:2017/01/09Expiry Date:2019/01/08

 

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 Titration)91.3%
Loss on drying
 
Less than12%(USP731)8.2%
Nonespecific DissaccharidesNMT10%7.3%
Protein
 
NMT6.0%(USP38)4.7%
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)6.5
Specific Rotation
 
- 12°~ -20°(USP781S)-17.5°
Residue on Ignition
 
20%-30%(dry base)(USP281)25.5%
OrganicVolatile Residual(Ethanol)
 
NMT0.5% (USP467)PASS
Clarity (5%H2O solution)
 
<0.35@420nm0.22
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

 

 

 

Production Flow Chart of Marine Chondroitin Sulfate

 

Marine Cartilages

 

Pre-treatment(cartilages selecting and washing)                    

 

Boiling ( add NACL,boil for 5 hours at the temperature of 90℃)

 

Enzymolysis (add pancreatin, add NAOH to adjust the PH value to 8.5-9.0, boil for 6 hours at the temperature of 48℃-50℃

 

 

Flitration

 

First sedimentation(add ethanol to dissolve out the crude chondroitin sulfate)

 

Hydrolysis (add water and NACL,add NAOH to adjust PH value to about 9.0. Adjust temperature to 48℃-50℃

 

Flitration

 

Second sedimentation(add ethanol to dissolve out purified chondroitin sulfate

 

 

Dehydration (add ethanol to dehydrate the water out of chondroitin sulfate

 

 

Centrifugation (get rid of ethanol)

 

Drying

 

 

Milling and Sifting

 

Blending (No other materials are added, just mixing)

 

Packing and testing

 

Chondroitin sulfate in 25KGS/drum