USP40 Standard Chondroitin Sulfate Sodium extracted from Bovine Cartilage
As a professional manufacturer of chondroitin sulfate, we upgrade our quality standard of chondroitin sulfate to USP40 standards, which is the most latest USP quality standard for chondroitin.
Compared with previous version of USP monograph, Below are the changes in the USP40 monograph for chondroitin sulfate:
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.
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.
Specification of chondroitin sulfate that is up to USP40 standard:
|Product:||Chondroitin Sulfate Sodium|
|Net Weight:||25KG/DRUM||Gross weight:||27.5KG/DRUM|
|Manufacturing Date:||2017/07/15||Expiry Date:||2019/07/14|
SPECIFICATIONS (TEST METHOD)
|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||Pass|
|Specific Rotation: Meet the requirements for optimal Rotation||Pass|
|Loss on drying||Less than12%(USP731)||8.6%|
|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)||＜0.5% (USP467)||PASS|
|Clarity (5%H2O solution)||<0.35@420nm||0.21|
|Bulk Density||＞ 0.5g/ml||Pass|
|Total Bacteria Count||<1000CFU/g (USP2021)||Pass|
|Yeast & Mold||<100CFU/g (USP2021)||Pass|
|Staphylococcus Aureus||Negative (USP2022)||Negative|
|Enterobacteria||Negative in 1 gram (USP2022)||Negative|
|Particle size||100% through 80 mesh||Pass|
|Conform to USP40 standards|
|Storage: 25kg/drum, keep in an airtight container, protected from light.|
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 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!
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