High Pure White Chondroitin Sulfate Sodium Powder With Drug Master File DMF

Basic Information
Place of Origin: CHINA
Brand Name: HS
Certification: GMP, DMF, ISO
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 Assay(ODB): 90%
Certificate: GMP ISO Loss On Drying: Less Than10%(USP731)
Raw Material: Bovine Cartilage Protein: NMT6.0%(USP38)
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White Chondroitin Sulfate Sodium Powder with 90% Assay CPC Titration Verified by NSF-GMP 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.
 
Chondroitin Sulfate Sodium is a popular dietary supplement ingredient for joint care products. It is extracted from cartilages of health animals such as Avian, bovine,porcine or shark. It is also commonly used in combination with other joint care ingredients such as Glucosamine, Collagen, and shark cartilage powder.  This Chondroitin Sulfate Sodium is from Bovine Cartilage.
 
Please see the specification sheet of our Chondroitin Sulfate Sodium:

Product: Chondroitin Sulfate sodium
Original Bovine(Terrestrial) Report Date 2019/02/17
Batch No.: HS1902038 Quantity: 1000KGS
Net Weight: 25KG/DRUM Gross weight: 27.5KG/DRUM
Manufacturing Date: 2019/02/10 Expiry Date: 2021/02/09

 

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. Most chondroitin sulfate is used for joint care dietary supplements. This could takes about 85% of the chondroitin market. The finished dosage form could be tablets, capsules or sachets.

 

2. Some chondroitin sulfate is used to produce drugs to treat joint inflamations, including the tablets and capsules or even cream.Usually, it is EP grade Chondroitin sulfate.

 

3. Chondroitin sulfate extracted from shark chondroitin could be used to produce eye drops.

 

4. EP grade or Injectable chondroitin sulfate is used to produce the injections.High Pure White Chondroitin Sulfate Sodium Powder With Drug Master File DMF 0High Pure White Chondroitin Sulfate Sodium Powder With Drug Master File DMF 1

Contact Details
Carol

Phone Number : +8618868305036

WhatsApp : +8618868305036