Active Ingredients: Chondroitin

Chondroitin sulfate oral grade

Description:

Chondroitin sulfate from mammalians contains CS-A with minor amounts of CS-C. Both of them are macromolecules made by alternate sequences of D- glucuronate and N-acetyl-galactosamine -4-O- ( or 6-O-) sulfate.This active ingredient is obtained from bovine cartilage by several purification steps that include validated procedures of viral inactivation.

 

Use:

Antiartrosic agent used in Human and Veterinary medicine. In veterinary medicine it is used in articular pathologies in racing horses; joint disorders in pets. In human medicine it is used  in health food, in beverages and in zootechny and in the treatments of certain articular pathologies. It is used for oral formulations such us capsules, soft capsules, bags, tablets, and topic formulations like ointments.

 

Described in USP and EP.

 

 

Mean Characteristics:

It is a white to almost white powder, extremely hygroscopic.

 

Presentation: 

Bulk powder in double polyethylene bag contained in lined drums containing 5, 10, 25 and 50 kg.

 

Specification according EP:

 

Appearance
White or almost White powder
Identification: Electrophoresis
Complies
Identification: Sodium
Complies
Identification: IR
Complies
Assay
95.0 – 105.0 % db
Solubility 5%
Clear solution
Loss on drying
Not more than 12.0 %
pH 5%
5.5 – 7.5
Specific rotation 5%
-20.0º and -30.0º
Intrinsic viscosity
0.01 m3/kg to 0.15 m3/kg
Chlorides
Not more than 0.50 %
Heavy Metals
 Lees than 20 ppm
Related substances
Not more than 2 %
Protein
Not more than 3.0%
Total bacterial count
Not more than 1000 UFC/g
Escherichia coli
Absence/g
Salmonella spp
Absence/g
Pseudomona Aeruginosa
Absence/g
Enterobacteria and Certain other gram-negative bacteria
Absence/g

Specification according USP:

Appearance
White or almost White yellow powder
Identification: Sodium
Complies
Identification: IR
Complies
Assay
90.0 – 105.0 % db
Abs. 5 % 420 nm
not greater than 0.35
Loss on drying
Not more than 10.0 %
pH sol. 1%
5.5 – 7.5
Specific rotation
-20.0º and -30.0º
Proteins (Lowry)
Not less than 6.0 %
Residue on ignition
20.0 % - 30.0 %
Chloride
Not more than 0.50 %
Sulfate
Not more than 0.24 %
Heavy Metals
Not more than 20 ppm
Related substances
Less than 2 %
Total bacterial count
Not more than 1000 cfu per g
Molds and yeasts count
Not more than 100 cfu per g
Escherichia coli
Absence/g
Salmonella spp
Absence/g

 

Indications:

Antiarthrous, Dietary Suplements

Available in this countries:

América del Sur, Argentina, Rusia, Union Europea, USA