Bovine Source Chondroitin Sulfate Sodium Salt With DMF Documentation from GMP Manufacturer
What is chondroitin sulfate sodium ?
Chondroitin Sulfate sodium is a type of mucopolysaccharides extracted from cartilages of health animals for human consumption. This one is extacted from bovine cartilage.
Our company Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a GMP manufacturer of chondroitin sulfate sodium from bovine cartilage with purity of 90% by CPC titration. It is used for the production of Joint health tablets.
The consumption history of chondroitin sulfate sodium:
Chondroitin sulfate sodium has been used as a joint health ingredient for decades, starting from the USA which now still consumes the largest quantity of chondroitin sulfate in the world. EU countries and Japan followed the USA to consume the chondroitin sulfate. And nowdays, the markets in the Asia is growing rapidly. Chondroitin is now the most popular ingredient in Joint health supplements. It is usually used together with glucosamine, MSM in Tablest, capsules, and Powder form.
The specification of chondroitin sulfate sodium 90% by CPC Titration :
|roduct:||Chondroitin SULPHATE sodium|
|Net Weight:||25KG/DRUM||Gross weight:||27.5KG/DRUM|
|Manufacturing Date:||2017/05/14||Expiry Date:||2019/05/13|
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|
|Loss on drying||Less than12%(USP731)||8.6%|
|Heavy Metal||NMT20PPM (Method I USP231)||Pass|
|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)||NMT0.5% (USP467)||PASS|
|Clarity (5%H2O solution)||<0.35@420nm||0.21|
|Bulk Density||NLT 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|
|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 C ), 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.
9. Ukraine Registration is available
We have professional sales Team who will serve you timely and efficiently.
1. Fluent English Writing and Speaking.
2. Fast response to your request, either by email or by Whatsapp, Skype.
3. Our sales people has Professional knowledge of chondroitin sulfate sodium with more than 5 years experience in chondroitin sulfate industry.
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