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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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JIAXING HENGJIE BIOPHARMACEUTICAL CO.,LTD.

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Product Details

White Powder Chondroitin Sulfate Sodium Extracted from Bovine Cartilage USP39 Grade CPC 90% For Joint Health

 

Chondroitin Sulfate sodium is a type of mucopolysaccharides extracted from cartilages of health animals for human consumption. This one is extacted from bovine cartilage.

Our company Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a GMP manufacturer of chondroitin sulfate sodium from bovine cartilage with purity of 90% by CPC titration. It is used for the production of Joint health tablets.

 

Specifications:

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%

(USP36)

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

USP36

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

 

Applications:

 

The most common use of Bovine chondroitin sulfate sodium  is to produce joint health dietary supplements in combination with Glucosamine and MSM(Methyl-Sulfonyl-Methane) in Tablets. It could also be used to produce capsules and powders in sachets together with glucosamine and MSM.

 

Quality Management System

Below is the list of the key certificates or Docs in our quality management system. 

 

  • 2008-- A GMP workshop (300,000 clean class) was built and put into service. It was upgraded to 100,000 clean class in 2011
  •  
  • 2010 May -- Received the Drug Manufacturing License issued by the State FDA. It was renewed on October 22, 2014 and valid until October 21, 2019
  •  
  • 2010 October --ISO9001 & ISO 22000 Verified. It was renewed on Oct.11, 2018 and valid until October 11, 2021.
  •  
  • 2012 April --Pass the FDA site inspection with zero inspectional observation
  • .
  • 2012August --Received the NSF-GMP certificate and listed as a GMP manufacturer of dietary supplements on NSF website and renew the certificate every year.
  • 2012 September--- Register our plant at EU Commission as an animal by products manufacture, the approval number is 3300DZ0091 .
  •  
  • 2012 December –DMF NO. of Chondroitin Sulfate received from USFDA: 26474.
  •  
  • 2014 March--- MSC Verified for Shark Chondroitin and Shark Cartilage Powder. It was renewed on March 2, 2017 and valid until March 1, 2020.
  •  
  • 2016 March---HALAL Verified. It was renewed on March 30, 2016 and valid until March 29, 2019.
  • The Bovine chondroitin sulfate sodium is packed into Double PE bags, then it was put into a fiber drum with volume of 25KG. This is the picture of our fiber drum.