GMP Manufacturer of Bovine Chondroitin Sulfate Sodium , 90% Assay USP Grade with DMF

Basic Information
Place of Origin: China
Brand Name: HS
Certification: DMF,GMP
Model Number: USP Standard
Minimum Order Quantity: 50kgs
Price: Negotiable
Packaging Details: 25kgs/drum
Payment Terms: T/T, L/C
Supply Ability: 20 MT/Month
Certification: GMP And DMF Standard: USP40
Purity: 90% Origin: Bovine
Apperance: White Powder Loss On Drying: ≤10%
High Light:

chondroitin sodium sulfate

,

chondroitin sulfate USP

GMP Manufacturer of Bovine Chondroitin Sulfate Sodium , 90% Assay USP Grade with DMF 
 
who we are  ?
We are a GMP verified manufacturer of chondroitin sulfate sodium that up to USP40 standards, with DMF documentations in CTD formate.
 
What does our company ?
Established in 1997, Jiaxing Hengjie Biopharmaceutical Co.,ltd is one of the first chondroitin sulfate manufacturer in china. We have specialized in producing chondroitin sulfate for twenty years.
 
General introduction about bovine chondroitin sulfate:
Bovine chondroitin sulfate is a type of sulfated mucopolysaccharides extracted from bovine cartilages. It is a hygroscopic powder with white to yellowish color. Reports say that chondroitin sulfate is helpful in repaire the damaged cartilages in joints, thus could relief the pain caused by wear and tear of cartilages in joints. It is commonly used in the production of dietary supplements intended for joints health.
 
Specification of USP40 grade Bovine chondroitin sulfate sodium :
 

Product:Chondroitin SULPHATE sodium 
OriginalBovine(Terrestrial)Report Date2017/05/20 
Batch No.:HS1705035Quantity:1000KGS 
Net Weight:25KG/DRUMGross weight:27.5KG/DRUM 
Manufacturing Date:2017/05/14Expiry Date:2019/05/13 

 

ITEMS

 
SPECIFICATIONS (TEST METHOD)

 

RESULT

AppearanceWhite to off-white powderPass
IdentificationInfra 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 

Assay(ODB)
 

NLT90% (CPC)91.2%

Loss on drying
 

Less than12%(USP731)8.6%

Protein
 

NMT6.0%(USP38)4.8%

Sulfate
 

<0.24%(USP221)<0.24

Chloride
 

<0.5% (USP221)<0.5%

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@420nm0.21
Electrophoretic purityNMT2.0%(USP726)Pass
Bulk DensityNLT 0.5g/mlPass

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

Enterobacteria
 

Negative in 1 gram (USP2022)Negative
Particle size100% through 80 meshPass

Storage: 25kg/drum, keep in an airtight container, protected from light.
 

 
Quality Management :
 
1. The quality Management system of our company is established based on NSF-GMP guidline, and Chinese GMP guidline.
2. We have NSF-GMP for bovine chondroitin sulfate, issued by NSF, updated annually.
3. We have Drug Manufacturer lisence for chondroitin sulfate issued by China FDA, updated every 5 years, valid until October 21th,2017.
4. We have DMF documents in CTD formate for bovine chondroitin sulfate.
5. We have ISO9001 certificate and ISO22000(HACCP) certificate.
6. We have Halal Certificate
 
We are active in attending the international trade shows including: CPHI, Vitafoods, Supplyside etc.
 
CPHI 2014 in china, SHANGHAI
 
 GMP Manufacturer of  Bovine Chondroitin Sulfate Sodium , 90% Assay USP Grade with DMF 0
 
Supplyside West 2015 in Las Vegas, USA
 
GMP Manufacturer of  Bovine Chondroitin Sulfate Sodium , 90% Assay USP Grade with DMF 1
 
 

Contact Details
Carol

Phone Number : +8618868305036

WhatsApp : +8618868305036