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Injection Chondroitin Sulfate
ItemsSpecificationAppearanceWhite to off-white powderIdentificationInfra Red ConfirmedSodium reactionAssayNLT90%Loss on dr

CONTENT


Items

Standard

Description

White or light yellow powder

Solubility

Solution in water, solution in Sodium of Chloride isotonisch  0,9%, practically not solution in ethyl alcohol 96% and choloroform

Indentification

Conform to standards spectrum
  Red to magenta color appear
  Yellow flame appear

Transparency of solution

10% solution should be no more intensively than reference solution

Assay(CPC)

No Less Than 95%

Chromaticity of solution

10% solution should be no more than etalon

Loss on drying

No more than 10

pH

Between 5.0 and 7.0 (5% solution)

Specific Rotation

Between -18º and -28º (1% solution)

Heavy Metal

No more than 25PPM

Residual organic solvents,

Ethnol no more than 1.5%

Pyrogen

No more than 0.5 eu/mg

Total Bacteria Count

NMT100CFU/g

Yeast & Mold

NMT10CFU/g

Salmonella

Negative

Staphylococcus aureus

Negative

Particle size

100% through 60 mesh

 


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