White To Yellowish Powder USP40 Chondroitin Sulfate Sodium With 90% Purity From Bovine for Joint Health Supplements
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.
The main purpose of USP40 standards 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.
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.
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:||2019/07/15||Expiry Date:||2021/07/14|
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.|
Why choose our company as supplier of Chondroitin sulfate sodium ?
1. Our company was founded in 1997, our company has production experience of 20 years.
2. Our company has GMP workshop (Class D ), we are able to control the total mircrorganism ＜100 cfu/g.
and Yeast&Mold ＜10 cfu/g. Thus Our chondroitin sulfate sodium is None-Irradiated.
3. Our production facility is NSF-GMP verified, we have established a quality management system based NSF-GMP standard. ( US 21 CFR 1111).
4. China Drug Manufacturing Lisence for Chondroitin sulfate Sodium. We received the Drug Manufacturing Lisence from China FDA for production of Chondroitin Sulfate Sodium as API.
5. DMF documentation for Chondroitin Sulfate sodium is availalbe. US FDA DMF # : 26474.
6. ISO9000 and ISO22000 (HACCP)
7. HALAL Certifiate is available
8. Japan Registration. Foreign Drug Manufacturer Registration.
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