Porcine Cartilage Chondroitin Sulfate Sodium with 95% Purity White To Yellowish Powder
Description:
EP Grade Porcine Chondroitin sulfate sodium 95% is extracted from porcine cartilages with purity of 95% that complies with EP 7.0 standard. Porcine chondroitin sulfate sodium is powder of white to yellowish clolor, and is extremely hygroscopic once dried.
EP Grade porcine Chondroitin sulfate sodium is usually used for osteoarthritis. It is often used in combination with other ingredients, including manganese ascorbate, glucosamine sulfate, glucosamine hydrochloride, or N-acetyl glucosamine.
Specifications:
ITEM | SPECIFICATIONS | TEST METHOD |
Characters |
White to almost-white, Hygroscopic powder |
VISUAL |
Solution |
Freely soluble in water, Practically insoluble in acetone And in ethanol |
EP7.0 |
Identification |
Infrared absorption spectrophotometry Sodium reaction Related substances |
EP2.2.24 EP2.3.1 EP7.0 |
Ph | 5.5-7.5( EP2.2.3) | EP2.2.3 |
Specific Optical Rotation | - 20°- -30° | EP2.2.7 |
Intrinsic Viscosity | 0.01M3/KG – 0.15M3/KG | EP7.0 |
Protein | NMT3.0 % | EP2.5.33 |
Chloride | NMT0.5 % | EP2.4.4 |
Heavy Metal | NMT20PPM | EP2.4.8 |
Loss On Drying | LESS THAN12 % | EP2.2.32 |
Assay | 95%-105 % | EP7.0 |
Total Viable Aerobic Count | NMT 1000CFU/G | EP2.6.12 |
Yeast and molds | NMT 100CFU/G | EP2.6.12 |
Staphylococcus Aureus | NEGATIVE | EP2.6.13 |
Pseudomonas Aeruginosa | NEGATIVE | EP2.6.13 |
Escherichia Coli | NEGATIVE | EP2.6.13 |
Salmonella | NEGATIVE | EP2.6.13 |
Enterobacteria | NEGATIVE | EP2.6.13 |
Other Pathogenic Bacteria | NEGATIVE/G | EP2.6.13 |
Particle Size | 100% THROUGH 60 MESH | IN-HOUSE |
Application of Chondroitin Sulfate Sodium
People suffering from arthralgia, articular pain or stiff joints Glucosamine Sulfate .
People suffering from arthritis or muscle inflammation.
People desiring to prevent arthropathies or caput femoris necrosis.
People suffering from scapulohumeral periarthritis, cervical spondylosis, rheumatoid disease, rheumatalgia, hyperosteogeny and sciatica.
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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