DMF Verified Bovine Chondroitin Sulfate with 90% assay , GMP
Manufacturer of Chondroitin
Our company has DMF documentation of chondroitin sulfate in CTD
format, we also have GMP certificate.
Jiaxing Hengjie Biopharmaceutical Co.,Ltd. is a GMP manufacturer of
bovine chondroitin sulfate with DMF documentation in CTD formate.
We have been producing and supplying chondroitin sulfate all around
the world for around 20 years, we are specialized and professional
in chondroitin sulfate industry.
Our production faclity is GMP verified, plus we have DMF
documentation in CTD formate for bovine chondroitin sulfate.
Please check our specification of bovine chondroitin sulfate as
|Product:||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
Our quality management system:
1. NSF-GMP. Our comapny had established our quality management
system based on NSF-GMP standards.
2. China Drug Manufacturing Lisence. We received the Drug
Manufacturing lisence of chondroitin sulfate as API from china FDA.
Our company is under the supervision of China FDA.
3. DMF Documentation : We submit our DMF documentation to US FDA,
and receive the DMF number from US FDA: 26474.
4. ISO 9001 and ISO22000( HACCP )
5. Halal Certificate: We have Halal Certificate for our bovine
We attend the trade show all around the world in Foods and API
Below are some of our presence at the show:
2015 CPHI SHANGHAI
2016 CPHI SHANGHAI