90% Purity Chondroitin Sulfate Bovine Sodium from GMP Manufacturer with Drug Master File DMF

Basic Information
Place of Origin: CHINA
Brand Name: HS
Certification: GMP, DMF
Model Number: 90%
Minimum Order Quantity: 1-50KGS
Price: USD45.0/KG-USD60.0/KG
Packaging Details: 25KGS/Drum
Delivery Time: 5-8 Working days
Payment Terms: L/C, T/T
Supply Ability: 30MT/Month
Product: Chondroitin Sulfate Sodium Purity: 90%
Certificate: GMP DMF: Available
Raw Material: Bovine Cartilage Apperance: White Powder
High Light:

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chondroitin sodium sulfate

90% Purity Chondroitin Sulfate Sodium from GMP Manufacturer with Drug Master File DMF
 
 
Our company is a GMP Manufacturer of 90% chondroitin sulfate sodium and we have Drug Master File (DMF) for chondroitin sulfate sodium.
 
 
The chondroitin sulfate sodium is extracted from bovine cartilages, it is a type mucopolysaccharide which is 
good for the joint health. It is usually of white to off white color, extremely hygroscopic once dried, avoid the exposure to the air, stored in a cool and dry place.
 
Please see the specification sheet of our Chondroitin Sulfate Sodium:
 

Product: Chondroitin Sulfate sodium
Original Bovine(Terrestrial) Report Date 2017/02/17
Batch No.: HS1702038 Quantity: 1000KGS
Net Weight: 25KG/DRUM Gross weight: 27.5KG/DRUM
Manufacturing Date: 2017/02/10 Expiry Date: 2019/02/09

 

ITEMS


SPECIFICATIONS (TEST METHOD)

 

RESULT

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  
Assay(ODB)
 
NLT90% (CPC Titration)  91.6%
Loss on drying
 
Less than12%(USP731) 8.0%
Nonespecific Dissaccharides NMT10% 7.2%
Protein
 
NMT6.0%(USP38) 4.9%
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) 6.4
Specific Rotation
 
- 20°~ -30°(USP781S) -22.5°
Residue on Ignition
 
20%-30%(dry base)(USP281) 25.5%
OrganicVolatile Residual(Ethanol)
 
NMT0.5% (USP467) PASS
Clarity (5%H2O solution)
 
<0.35@420nm 0.22
Electrophoretic purity NMT2.0%(USP726) Pass
Bulk Density NLT 0.5g/ml Pass
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 size 100% through 80 mesh Pass
Storage: 25kg/drum, keep in an airtight container, protected from light.

 
The advantage of our Chondroitin Sulfate Sodium:
 
1. NSF-GMP.  Our chondroitin sulfate has the NSF-GMP certificate
 
2. None-Irradiated Our chondroitin sulfate is produced in the GMP workshop, the bacteria is controlled, no irradiation is needed.
 
3. Laboratory testing.  We have established a laboratory within our facility, which could conduct all the above listed testing.
 
4. Drug Master File (DMF) available. We have received the DMF number for chondroitin sulfate from US FDA, the DMF # is 26474. and the DMF documentation is avaliable.
 
The application of chondroitin sulfate sodium:
 
1. Joint Health:  The most popular application for chondroitin sulfate sodium is the joint health. It is usually used together with glucosamine, MSM in Tablets, Capsules, or powder form.
 
2. Eye drop.  Chondroitin sulfate is also used in the eye drop products.
 
3. Cosmetics:  Some cosmetics also used chondroitin sulfate.

Contact Details
Carol

Phone Number : +8618868305036

WhatsApp : +8618868305036