USP Grade White Chondroitin Sulphate Sodium Avian Extracted Assay CPC 90% With GMP
Chondroitin sulphate is a sulfated liner glycosaminoglycan extracted from cartilages of healthy animals such as bovine, porcine, avian and shark. It exists most commonly in the form of chondroitin sulphate sodium with content of chondroitin sulfate from 90% to 105% calculated on dry basis. Chondroitin Sulfate is included in both US Pharmacopoeia and European Pharmacopoeia and widely used in Dietary Supplements as well as Drugs.
Avian chondroitin sulfate sodium is the mucopolysaccharide extracted from avian cartilages. It is usually used in dietary supplements for joint health.
Our company 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.
Specifications:
ITEMS |
SPECIFICATIONS (TEST METHOD) |
RESULT |
Appearance | White to off-white powder | Pass |
Identification | Infra Red Confirmed (USP197K) | Pass |
Sodium reaction (USP191) | Positive | |
Assay(dry base) | NLT90% (CPC) | 91.8% |
Loss on drying | Less than10%(USP731) | 8.6% |
Protein | NMT6.0%(USP41) | 3.86% |
Heavy Metal | NMT20ppm(MethodⅡUSP231) | Pass |
pH (1%H2O solution) | 5.5-7.5(USP791) | 6.51 |
Specific Rotation | - 20°~ -30°(USP781S) | -23.3° |
Chloride | NMT0.5%(USP221) | <0.5% |
Sulfates | NMT0.24%(USP221) | <0.24% |
Residual solvent(ethanol) | NMT5000PPM(USP467) | Pass |
Residual solvent(methanol) | NMT3000PPM(USP467) | Pass |
Residue on Ignition(dry base) | 20%-30% (USP281) | 22.6% |
Clarity (5%H2O solution) | <0.35@420nm | 0.15 |
Electrophoretic purity | NMT2.0%(USP726) | Pass |
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 |
Particle size | 100% through 80 mesh | Pass |
The most common use of Avian 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.
Applications:
Quality Management System
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 Sep 2, 2019 and valid until Sep 1, 2024
2010 October --ISO9001 & ISO 22000 Verified. It was renewed on Oct.11, 2018 and valid until Oct11, 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, 2021.
2018 March---Obtain Certificate of Recording for Export Food Manufacturing Enterprises and valid until March 2023
2019 June--- Obtain API registration number Y20190000453
The Avian 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.
Below is our extracting tanks
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