CAS#9082-07-9 White Powder Chondroitin Sulfate From Bovine EP 95% With GMP Certificate
What is chondroitin sulphate?
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.
As one of the first chondroitin sulphate manufacturers in China, our company has been engaged in the production and marketing of chondroitin sulphate for over 20 years. The qualification certificates of our company include the Drug Manufacturing License from Chinese FDA, NSF-GMP Certificate, Halal Certificate and DMF Documentation. We have also finished the registrationof chondroitin sluphate in Ukraine, other CIS countries and Japan.
Specifications:
ITEM | SPECIFICATIONS(TEST MEHTOD) | RESULT |
Characters | White to almost-white, | PASS |
Hygroscopic powder (VISUAL) | ||
Solution | Freely soluble in water, | PASS |
Practically insoluble in acetone | ||
And in ethanol( EP7.0) | ||
Identification | Infrared absorption spectrophotometry( EP2.2.24) | PASS |
Sodium reaction(EP2.3.1) | POSITIVE | |
Related substances (EP7.0) | <2.0% | |
Related substances:examine the principal band in the electropherograms obtained in the test for related substances(EP) | PASS | |
pH | 5.5-7.5( EP2.2.3) | 6.2 |
Specific Optical Rotation | - 20°- -30°(EP2.2.7) | -26.7° |
Intrinsic Viscosity | 0.01M3/KG – 0.15M3/KG(EP7.0) | 0.07M3/KG |
Protein | NMT3.0 %( EP2.5.33) | 2.8% |
Chloride | NMT0.5 %( EP2.4.4) | <0.5% |
Heavy Metal | NMT20PPM (EP2.4.8) | <20PPM |
Loss On Drying | LESS THAN12 %( EP2.2.32) | 7.11% |
Assay | 95%-105 %( EP7.0.CPC titration) | 99% |
Organic Volatile Impurities (Ethanol ) | NMT0.5% (EP7.0) | <0.5% |
Total Viable Aerobic Count | NMT 1000CFU/G(EP2.6.12) | PASS |
Yeast and molds | NMT 100CFU/G (EP2.6.12) | PASS |
Staphylococcus Aureus | NEGATIVE(EP2.6.13) | PASS |
Pseudomonas Aeruginosa | NEGATIVE(EP2.6.13) | PASS |
Escherichia Coli | NEGATIVE(EP2.6.13) | PASS |
Salmonella | NEGATIVE(EP2.6.13) | PASS |
Enterobacteria | NEGATIVE(EP2.6.13) | PASS |
Bile Tolerant Gram Negative Bacteria(g) |
NEGATIVE(EP2.6.13) | PASS |
Other Pathogenic Bacteria | NEGATIVE/G (EP2.6.13) | PASS |
Bulk Density | >0.55g/ml | 0.68g/ml |
Particle Size | 100% THROUGH 80MESH |
PASS |
Funcation of chondroitin sulfate
1. Rehabilitate the attrited arthrosis cartilage,is a key structural component in cartilage and acts as a lubricant.
2. Enhance the immunity and improve osteoporosis.
3. Cure neuralgia, arthralgia and process the concrescence of wounds.
4. Promote the synthesis of mucopolysaccharides, advance the viscosity of synovia, and improve the metabolism of arthroidal cartilage.
5. Has some curative effect on rheumatoid arthritis and hepatitis.
6. Has some curative effect on melanoma, lung cancer and renal carcinoma.
- Application chondroitin sulfate
1. Used as medicine's raw material, it can promote the synthesis of mucopolysaccharides, advance the viscosity of synovia, and improve the metabolism of arthroidal cartilage with evident effect of relieving inflmmation and easing pain.
2. Used as nutritive food of diabetes, it can cure enteritis instead of cortisol and has some curative effect on rheumatoid arthritis and hepatitis.
3. Used in cosmetic feed and food additive industry.
The advantage of our Chondroitin Sulfate Sodium:
1. NSF-GMP. Our chondroitin sulfate has the NSF-GMP certificate
2. None-Irradiated Our chondroitin sulfate is produced in the GMP workshop, the bacteria is controlled, no irradiation is needed.
3. Laboratory testing. We have established a laboratory within our facility, which could conduct all the above listed testing.
4. Drug Master File (DMF) available. We have received the DMF number for chondroitin sulfate from US FDA, the DMF # is 26474. and the DMF documentation is avaliable.
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