Bovine Chondroitin Sulfate Sodium USP Standard GMP / DMF Quality Certificate For Joint Care
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.
Our production facility is GMP workshop that is NSF-GMP verified. we also have DMF for chondroitin Sulfate.
The Specification of Bovine chondroitin Sulfate USP38 grade:
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 |
What is the function of bovine chondroitin sulfate sodium ?
Chondroitin sulfate sodium has been used as a joint health ingredient for decades, starting from the USA which now still consumes the largest quantity of chondroitin sulfate in the world. EU countries and Japan followed the USA to consume the chondroitin sulfate. And nowdays, the markets in the Asia is growing rapidly. Chondroitin is now the most popular ingredient in Joint health supplements. It is usually used together with glucosamine, MSM in Tablest, capsules, and Powder form.
Applications of Bovine Chondroitin Sulfate Sodium:
1.Help to reduce pain in Osteoarthritis. This is the most common use of chondroitin sulfate as dietary supplements.
2. Eye Drops. Chondroitin may be found in some products used to treat eye disorders, such as dry eyes and cornea inflammation.
3.Bone diseases
A study reports that chondroitin sulfate may benefit people who have Kaschin-Beck disease, which affects the bone and causes joint pain or stiffness.
The Quality Management System in our company.
Following is the quality management system of our company, according to the time:
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.
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