|
Place of Origin | CHINA |
Brand Name | HS |
Certification | GMP |
Model Number | USP40 |
USP43 Grade Chondroitin Sulfate Sodium From Bovine Cartilage With GMP
As a professional manufacturer of chondroitin sulfate, we upgrade our quality standard of chondroitin sulfate to USP43 standards, which is the most latest USP quality standard for chondroitin.
Our company gurantee that all the chondroitin sulfate we produce and sell are real chondroitin, with no adultrant. You can send our samples to all independant third party laboratory for testing.
Compared with previous version of USP monograph, Below are the changes in the USP43 monograph for chondroitin sulfate:
1. Identification:
Add : Dissacharides Compostion: △ DI-4S is the most abundant, followed by the △ DI-6S, with △ DI-OS being the least abundant of the three.
2. Loss on Drying:
Change from "Max 10%" to "Max 12%"
3. Add : Limit Nonespecific Dissacharides : No more than 10%.
The main purpose of the above changes is to identify the economically motivated adulterated chondroitin sulfate. Both Dissacharides composition testing and the nonespecific dissacharides involve a testing method called Enzymatic HPLC. This method will easily indentify the adulterant in the chondroitin sulfate.
Specification of chondroitin sulfate that is up to USP43 standard:
ITEMS | SPECIFICATIONS (TEST METHOD) | RESULT |
Appearance | White to off-white powder | Pass |
Identification | A:Infra Red Confirmed (USP197K) | Pass |
B:Sodium reaction (USP191) | Positive | |
C:Disaccharide Composition the ratio of the peak response of △Di-4S / △Di-6S is NLT 1.0 | Pass | |
D: Specific Rotation between –20.0° to –30.0° | Pass | |
Assay(ODB) | NLT90% (CPC) | 93.5% |
Loss on drying | Less than12%(USP731) | 8.7% |
Protein | NMT6.0%(USP39) | 5.3% |
Heavy Metal | NMT20PPM (MethodIIUSP231) | Pass |
Nonspecific Disaccharides |
<10% | Pass |
PH (1%H2O solution) | 5.5-7.5(USP791) | 6.1 |
Chloride | NMT0.5%(USP221) | Pass |
Sulfates | NMT0.24%(USP221) | Pass |
Specific Rotation | - 20°~ -30°(USP781S) | -25.2° |
Residue on Ignition | 20%-30%(USP281) | 23.5% |
Clarity (5%H2O solution) | <0.35@420nm | 0.17 |
Electrophoretic purity | NMT2.0%(USP726) | 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 |
Particle size | 100% through 80 mesh | Pass |
The advantage of our company:
1. NSF-GMP Verified production facility.
2. DMF documentation for chondroitin sulfate are available.
3. Our company has its own laboratory which could perform all the testing items listed in the USP standard.
4. All our chondroitin are produced in GMP clean workshop, thus, it is none irradiated.
The application of chondroitin sulphate
1. Promote the regeneration of new cartilage tissues
2. Help to maintain the integrity of the joint structure
3. Anti-inflammatory effect
4. Help to lubricate the joints
5. Chondroitin sulfate may help to inhibit joint edema and effusion, and helps to prevent stenosis of joint care.
This is the HPLC equipment to test the Assay:
The most trustable chondroitin sulfate manufacturer you could ever find in china, with 20 years experience in production and quality control. Contact us to start your success in chondoritin business!
Contact Us at Any Time