Quick Detail
Place of Origin
Brand Name
HS
Model Number
90%
HS-CODE
29-
Package & Delivery Lead Time
Package
25KGS/Drum
Delivery Lead Time
5-8 Working days
Detailed Description
90% Purity Chondroitin Sulfate Sodium from GMP Manufacturer with Drug Master File DMF
Our company is a GMP Manufacturer of 90% chondroitin sulfate sodium and we have Drug Master File (DMF) for chondroitin sulfate sodium.
The chondroitin sulfate sodium is extracted from bovine cartilages, it is a type mucopolysaccharide which is
good for the joint health. It is usually of white to off white color, extremely hygroscopic once dried, avoid the exposure to the air, stored in a cool and dry place.
Please see the specification sheet of our Chondroitin Sulfate Sodium:
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Product: | Chondroitin Sulfate sodium |
Original | Bovine(Terrestrial) | Report Date | 2017/02/17 |
Batch No.: | HS1702038 | Quantity: | 1000KGS |
Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM |
Manufacturing Date: | 2017/02/10 | Expiry Date: | 2019/02/09 |
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 Titration) | 91.6% |
Loss on drying
| Less than12%(USP731) | 8.0% |
Nonespecific Dissaccharides | NMT10% | 7.2% |
Protein
| NMT6.0%(USP38) | 4.9% |
Sulfate
| 0.24%(USP221) | 0.24 |
Chloride
| 0.5% (USP221) | 0.5% |
Heavy Metal
| NMT20PPM (MethodIUSP231) | Pass |
PH (1%H2O solution)
| 5.5-7.5(USP791) | 6.4 |
Specific Rotation
| - 20~ -30(USP781S) | -22.5 |
Residue on Ignition
| 20%-30%(dry base)(USP281) | 25.5% |
OrganicVolatile Residual(Ethanol)
| NMT0.5% (USP467) | PASS |
Clarity (5%H2O solution)
| <0.35@420nm | 0.22 |
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 |
Storage: 25kg/drum, keep in an airtight container, protected from light. |
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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.
The application of chondroitin sulfate sodium:
1. Joint Health: The most popular application for chondroitin sulfate sodium is the joint health. It is usually used together with glucosamine, MSM in Tablets, Capsules, or powder form.
2. Eye drop. Chondroitin sulfate is also used in the eye drop products.
3. Cosmetics: Some cosmetics also used chondroitin sulfate.
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