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Chondroitin Sulphate Sodium
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| Place of Origin | China |
| Brand Name | HS |
| Certification | GMP, ISO, MSC, HALAL |
| Model Number | 95% Purity |
EP Grade Marine Shark Chondroitin Sulfate Sodium With 95% Assay With GMP For Joints
Marine shark chondroitin sulfate sodium is extracted from the marine shark cartilages, with 95% purity of chondroitin sulfate, it has similar specifications with bovine or avian chondroitin sulfate, but with a better quality because shark cartilages are cleaner, and it is said that shark cartilages helps to inhibit the growth of tumor.
Founded in 1997, Jiaxing Hengjie Biopharmaceutical Co., Ltd has been developed into a group company which provides the solution of Joint health ingredients to serve the customers all around the world. The subsidiary companies of Hengjie include Jiaxing Nudikon Lifescience Co., Ltd, Amnutra( China). Co., Ltd and HS Biopharmaceuticals, Inc. Hengjie established two quality devisions for food and drug industries respectively to ensure the quality of products delivered to its valued customers.
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 Shark Chondroitin Sulfate
| Product: | ||||||||||
| Original: | Report Date: | 2019/05/13 | ||||||||
| Batch No.: | Quantity: | 25KG | ||||||||
| Net Weight: | Gross weight: | 27.5KG/DRUM | ||||||||
| 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 | - 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 | 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 | ||||||||
The shark cartilages we used to produce shark chondroitin sulfate comes from:
1. Wenzhou City in China
2. Taiwan
3. Indonesia
Below are pictures of shark cartialges :
Why choose our company as supplier of Chondroitin sulfate sodium ?
1. Our company was founded in 1997, our company has production experience of 20 years.
2. Our company has GMP workshop (Class D ), we are able to control the total mircrorganism ＜100 cfu/g.
and Yeast&Mold ＜10 cfu/g. Thus Our chondroitin sulfate sodium is None-Irradiated.
3. Our production facility is NSF-GMP verified, we have established a quality management system based NSF-GMP standard. ( US 21 CFR 1111).
4. China Drug Manufacturing Lisence for Chondroitin sulfate Sodium. We received the Drug Manufacturing Lisence from China FDA for production of Chondroitin Sulfate Sodium as API.
5. DMF documentation for Chondroitin Sulfate sodium is availalbe. US FDA DMF # : 26474.
6. ISO9000 and ISO22000 (HACCP)
7. HALAL Certifiate is available
8. Japan Registration. Foreign Drug Manufacturer Registration.
9. Ukraine Registration is available
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