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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

Contact name:Carol

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Product Details

Bovine Chondroitin Sulfate Sodium by GMP Manufacturer with DMF Documentation

 

Our company Jiaxing Hengjie Biopharmaceutical Co.,ltd. is able to produce and supply Bovine chondroitin sulfate that is GMP verified, and with DMF documentation.

 

Founded in 1997, our company is now a manufacturer of chondroitin sulfate for over 20 years. and Since 2012, Our compnay had been NSF-GMP verified manufacturer of chondroitin sulfate. And at the same year, we submit our DMF(Drug Master File) documentation in CTD Form of chondroitin sulfate to US FDA, and we get the DMF number : #26474. Also DMF Documentation is available for your review.

 

The Specification of bovine chondroitin sulfate sodium:

 

ITEMS

SPECIFICATIONS

TEST METHOD

Appearance

White to off-white powder

Visual checking

Identification

Infra Red Confirmed

(USP197K)

 

Sodium reaction

(USP191)

Assay(ODB)

NLT90%

(CPC Titration)

Loss on drying

Less than10%

(USP731)

Protein

NMT6.0%

(USP41)

Heavy Metal

NMT20PPM

(Method I USP231)

PH (1%H2O solution)

5.5-7.5

(USP791)

Specific Rotation

- 20°~ -30°

(USP781S)

Residue on Ignition

20%-30%

(dry base)(USP281)

Organic Volatile Residual

NMT0.5%

(USP467)

Clarity (5%H2O solution)

<0.35@420nm

USP41

Electrophoretic purity

NMT2.0%

(USP726)

Total Bacteria Count

<1000CFU/g

(USP2021)

Yeast & Mold

<100CFU/g

(USP2021)

Salmonella

Negative

(USP2022)

E.Coli

Negative

(USP2022)

Staphylococcus Aureus

Negative

(USP2022)

Particle size

100% through 80 mesh

Pass

 

 

What is the function of chondroitin sulfate in joints ?

Please see below picture

 

 

 

Studies show that bovine chondroitin sulfate sodium helps to slow the breakdown of cartilages in joints because it is considered as the building blocks for cartilage. It is widely used in dietary supplements products intended for osteoarthritis usually in combination with other joint health ingredients including D-glucosamine sulfate potassium chloride, D-glucosamine sulfate sodium chloride, D-glucosamine Hydrochloride, collagen, shark cartilage powder and Hyaluronic acid.

 

The Application of bovine Ch

 

Tablets

Bovine chondroitin sulfate sodium is widely used in combination with Glucosamine and MSM(Methyl-Sulfonyl-Methane) in Tablets as dietary supplements intended for joint health

Capsules

Bovine chondroitin sulfate sodium could also be served in capsules form together with glucosamine and MSM.

Powder form

 Bovine chondroitin sulfate could also be produced into powder form in sachets

 

 

Quality Management System

 

  • 2010 May----Received the Drug Manufacturing License issued by State FDA, Renewed in October 2014.
  • 2010 October---ISO9001& ISO22000 Verified
  • 2012 August---NSF-GMP Verified
  • 2012 September---Registered as animal by products manufacturer in EU, Approval number is 3300DZ0091.
  • 2012 December---  DMF # for chondroitin sulfate: 26474. DMF documents are available.
  • 2014 March--- MSC Verified for shark chondroitin and shark cartilage powder
  • 2016 March---HALAL Verified

 

The packing of Bovine chondroitin sulfate sodium USP41 CPC 90%