GMP of White Powder Chondroitin Sulfate Bovine Sodium Assay CPC90% USP Grade Used for Joint healthy Care
Bovine Chondroitin sulfate sodium is extracted from the bovine cartilages with 90% content of chondroitin sulfate sodium by CPC Titration method, which conform to USP Standards.
Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a GMP Verified manufacturer of bovine chondroitin sulfate sodium with DMF documentation available. Founded in 1997, Our company is one of the first chondroitin sulfate manufacturers in china, we are professional in chondroitin sulfate production and supplying.
The Specification of Bovine Chondroitin Sulfate Sodium
Product: | Chondroitin Sulfate Sodium | ||
Original | Bovine(Terrestrial) | Report Date | 2019/06/19 |
Batch No.: | HS1906028 | Quantity: | 1000KGS |
Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM |
Manufacturing Date: | 2019/06/13 | Expiry Date: | 2021/06/12 |
TESTING ITEMS |
SPECIFICATIONS (TEST METHOD) |
RESULT |
|
Appearance | White to off-white powder | Pass | |
Identification | Infra Red Confirmed (USP197K). | Pass | |
Sodium reaction (USP191) | Positive | ||
The chromatogram of the enzymatically digested sample solution as obtained in the test for the limit of nonspecific disaccharides shows three main peaks corresponding to △DI-4S, △DI-6S,△DI-OS in the enzymatically digested standard solution. By peak area response, △ DI-4S is the most abundant, followed by the △ DI-6S, with △ DI-OS being the least abundant of the three | |||
Assay(ODB) | NLT90% (CPC) | 91.2% | |
Loss on drying | Less than10%(USP731) | 8.6% | |
Protein | NMT6.0%(USP38) | 4.8% | |
Sulfate | <0.24%(USP221) | <0.24 | |
Chloride | <0.5% (USP221) | <0.5% | |
Heavy Metal | NMT20PPM (Method I USP231) | Pass | |
PH (1%H2O solution) | 5.5-7.5(USP791) | 6.3 | |
Specific Rotation | - 20°~ -30°(USP781S) | -23.5° | |
Residue on Ignition | 20%-30%(dry base)(USP281) | 24.5% | |
OrganicVolatile Residual(Ethanol) | NMT0.5% (USP467) | PASS | |
Clarity (5%H2O solution) | <0.35@420nm | 0.21 | |
Electrophoretic purity | NMT2.0%(USP726) | Pass | |
Bulk Density | NLT 0.5g/ml | 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 | |
Enterobacteria | Negative in 1 gram (USP2022) | Negative | |
Particle size | 100% through 80 mesh | Pass | |
Conform to USP39 standards | |||
Storage: 25kg/drum, keep in an airtight container, protected from light. |
The Function of Chondroitin Sulfate Sodium
The 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.
Our company has a higer standard of quality management than other manufacturer of chondroitin. Please see the below Quality Management system of our company:
1. NSF-GMP Verified
Our production facility is NSF-GMP verified since the year of 2012
2. ISO 9001/ ISO22000
Our company is ISO9001 verfied and pass the ISO22000 which is HACCP.
3. DMF dcoumentaion and DMF number are avaliable.
Our company has the US DMF number for chondroitin sulfate sodium: #26474. EU DMF documentation for chondroitin sulfate are also available.
4. Halal Certificate:
We have the Halal Certificate for the Bovine Chondroitin Sulfate Sodium.
5. Japan Foreign Drug Manufacture Registration
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