|
Trade Verify
Address: No.20 Tongyi Road, Xinfeng Industrial Park, Jiaxing City Zhejiang 314005 China
Contact name:Carol
JIAXING HENGJIE BIOPHARMACEUTICAL CO.,LTD. |
|
Verified Suppliers
|
|
White Chondroitin Sulfate Sodium Powder with 90% Assay CPC
Titration Verified by NSF-GMP 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.
Chondroitin Sulfate Sodium is a popular dietary supplement
ingredient for joint care products. It is extracted from cartilages
of health animals such as Avian, bovine,porcine or shark. It is
also commonly used in combination with other joint care ingredients
such as Glucosamine, Collagen, and shark cartilage powder.
This Chondroitin Sulfate Sodium is from Bovine Cartilage.
Please see the specification sheet of our Chondroitin Sulfate
Sodium:
| Product: | Chondroitin Sulfate sodium | |||||||
| Original | Bovine(Terrestrial) | Report Date | 2019/02/17 | |||||
| Batch No.: | HS1902038 | Quantity: | 1000KGS | |||||
| Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | |||||
| Manufacturing Date: | 2019/02/10 | Expiry Date: | 2021/02/09 | |||||
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 (Method I USP231) | 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. | ||||||||
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. Most chondroitin sulfate is used for joint care dietary supplements. This could takes about 85% of the chondroitin market. The finished dosage form could be tablets, capsules or sachets.
2. Some chondroitin sulfate is used to produce drugs to treat joint inflamations, including the tablets and capsules or even cream.Usually, it is EP grade Chondroitin sulfate.
3. Chondroitin sulfate extracted from shark chondroitin could be used to produce eye drops.
4. EP grade or Injectable chondroitin sulfate is used to produce
the injections.
