EP Grade Bovine Chondroitin Sulfate Sodium Powder EP 95% With GMP For Joint Care Ingredient
Our company produce and supply EP7.0 grade bovine chondroitin sulfate. It is extracted from Bovine cartilages, and EP grade chondroitin sulfate has a higer purity of 95%, and less content of protein of 3.0%.
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.
The Specification sheet of EP Grade Bovine Chondroitin Sulfate:
ITEM | SPECIFICATIONS(TEST MEHTOD) | RESULT |
Characters | White to almost-white, | PASS |
Hygroscopic powder (VISUAL) | PASS | |
Solution | Freely soluble in water, | PASS |
Practically insoluble in acetone | PASS | |
And in ethanol( EP7.0) | PASS | |
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 | - 12°~ -19°(EP2.2.7) | -17° |
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 | c95%-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(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 |
What is the difference between EP grade Bovine chondroitin and USP grade Bovine Chondroitin ?
Bovine Chondroitin sulfate sodium EP grade is extracted from bovine cartilages. Compared with USP grade bovine chondroitin, it is with a higher assay of 95% while the assay of USP grade is 90% and with a lower protein limit (EP grade NMT 3.0%, USP NMT 6.0%).
What is the function of Bovine chondroitin sulfate sodium ?
Chondroitin sulfate performs a structural role in binding with the collagen fibrils present in articular cartilage.It is believed that avian chondroitin sulfate sodium helps to slow the breakdown of cartilages in joints because it is considered as the building blocks for cartilage. It is often used in dietary supplement products, helping relief the pain in the joints.
Applications:
Tablets |
Bovine chondroitin sulfate sodium is widely used in combination with Glucosamine and MSM(Methyl-Sulfonyl-Methane) in Tablets as dietary supplements intended for joint health |
Capsules |
Bovine chondroitin sulfate sodium could also be served in capsules form together with glucosamine and MSM. |
Powder form |
Bovine chondroitin sulfate could also be produced into powder form in sachets |
The advantage of the Quality Management system in our company
1. Produced in GMP Workshop, Mircroorganism is strictly controlled, no irradiation is needed.
2. All testing items fully tested by our own Laboratory. We have established an advanced laboratory within our factory, which is able to perform all the testing items listed above.
3. NSF-GMP Quality Mangement system. Our company is NSF-GMP qualified since 2012/
4. Drug Master File Available. The US DMF # of chondroitin sulfate is : 26474. The documentation is available in CTD Format.
5. HACCP: Our bovine chondroitin sulfate is HACCP verified.
6. Drug Manufacturing Lisence from China FDA. Our company has the Drug Manufacturing Lisence for chondroitin sulfate as API from China FDA.
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