EP Grade 95% Purity Bovine Chondroitin Sulfate white powder with DMF File
Chondroitin sulfate is a glycosaminoglycan, or GAG (also known as a mucopolysaccharide), which is a substance that attaches to collagen and elastin to form cartilage. This one is extracted from bovine cartilage. Our Chondroitin Sulfate sodium is produced and tested according to EP grade. It meets all the requirements of EP.
EP Grade Bovine Chondroitin sulfate sodium 95% is extracted from Bovine cartilages with purity of 95% that complies with EP 10.0 standard. Bovine chondroitin sulfate sodium is powder of white to yellowish clolor, and is extremely hygroscopic once dried.
EP Grade Bovine Chondroitin sulfate sodium can rehabilitate the attrited arthrosis cartilage,is a key structural component in cartilage and acts as a lubricant.
Jiaxing Hengjie Biopharmaceutical Co.,ltd is one of the first chondroitin sulfate manufacturers in china. Our company is specialized in the chondroitin sulfate production for over 20 years, and we have gained good reputation among our customers all around the world.
We got our DMF Number 26474 obtained from USFDA in Dec 2012.
Specifications of EP grade chondroitin sulfate sodium
White to almost-white,
Freely soluble in water,
Practically insoluble in acetone
And in ethanol
Infrared absorption spectrophotometry
|Specific Optical Rotation||- 20°- -30°||EP2.2.7|
|Intrinsic Viscosity||0.01M3/KG – 0.15M3/KG||EP10.0|
|Loss On Drying||LESS THAN12 %||EP2.2.32|
|Total Viable Aerobic Count||NMT 1000CFU/G||EP2.6.12|
|Yeast and molds||NMT 100CFU/G||EP2.6.12|
|Other Pathogenic Bacteria||NEGATIVE/G||EP2.6.13|
|Particle Size||100% THROUGH 60 MESH||IN-HOUSE|
Functions of chondroitin sulfate sodium:
1. Chondroitin Sulfate Sodium can rehabilitate the attrited arthrosis cartilage,is a key structural component in cartilage and acts as a lubricant.
2. Chondroitin Sulfate Sodium can enhance the immunity and improve osteoporosis.
3. Chondroitin Sulfate Sodium can cure neuralgia, arthralgia and process the concrescence of wounds.
4. Chondroitin Sulfate Sodium can promote the synthesis of mucopolysaccharides, advance the viscosity of synovia, and improve the metabolism of arthroidal cartilage.
5. Chondroitin Sulfate Sodium has some curative effect on rheumatoid arthritis and hepatitis.
6. Chondroitin Sulfate Sodium has some curative effect on melanoma, lung cancer and renal carcinoma.
The application of Chondroitin Sulfate Sodium :
1.People suffering from arthralgia, articular pain or stiff joints Glucosamine Sulfate .
2.People suffering from arthritis or muscle inflammation.
3.People desiring to prevent arthropathies or caput femoris necrosis.
4.People suffering from scapulohumeral periarthritis, cervical spondylosis, rheumatoid disease, rheumatalgia, hyperosteogeny and sciatica.
The advantages of our marine chondroitin sulfate sodium :
1. Our company was founded in 1997, our company has production experience of 20 years.
2. Our company has GMP workshop (Class D ), we are able to control the total mircrorganism ＜100 cfu/g.
and Yeast&Mold ＜10 cfu/g. Thus Our chondroitin sulfate sodium is None-Irradiated.
3. Our production facility is NSF-GMP verified, we have established a quality management system based NSF-GMP standard. ( US 21 CFR 1111).
4. China Drug Manufacturing Lisence for Chondroitin sulfate Sodium. We received the Drug Manufacturing Lisence from China FDA for production of Chondroitin Sulfate Sodium as API.
5. DMF documentation for Chondroitin Sulfate sodium is availalbe. US FDA DMF # : 26474.
6. ISO9000 and ISO22000 (HACCP)
7. HALAL Certifiate is available
8. Japan Registration. Foreign Drug Manufacturer Registration.
9. Ukraine Registration is available
The Quality Management System in our company
May 2008-- A GMP workshop (100,000 clean class) was built and put into service.
It was upgraded to 100,000 clean class in 2011
May 2010 -- Received the Drug Manufacturing License issued by the State FDA,
updated on Sep.22, 2019, valid until Sep.1,2024. The Number is 20140012.
Oct 2010 -- ISO9001 & ISO 22000 Verified, It was renewed on Oct.11, 2018 and
valid until October 11, 2021.
Apr 2012 -- Pass the FDA site inspection without major inspectional observation.
Aug 2012 -- Received the NSF-GMP certificate and listed as a GMP manufacturer of
dietary supplements on NSF website, update annually.
Sep 2012.--- Register our plant at EU Commission as a animal by products manufacture,
the approval number is 3300DZ0091
Dec 2012 -- DMF Number obtained from USFDA 26474.
Mar.2014---MSC Verified for Shark Chondroitin and Shark Cartilage Powder.
It was renewed on March 2, 2017 and valid until March 1, 2020.
Mar. 2015---Japan Foreign Drug Manufacturer Registration updated
2016 March---HALAL Verified. It was renewed on March 30, 2016 and valid until March 29, 2021.
2018 March---Obtain Certificate of Recording for Export Food Manufacturing Enterprises and valid until Mar.2023
2019 June--- Obtain API registration number Y20190000453
The photos of workshop:
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