Chondroitin Sulfate Sodium


CAS NO. : 9082-07-09

Pharmacopoeia standard :CP / EP / USP

HS CODE : 3001.9090.99

File service:Chinese GMP / DMF


SourcePorcine cartilage tissues such as throat bone, nasal bone, trachea.

CharactersWhite or almost white powder, hygroscopic.

ProcessChondroitin Sulfate Sodium is extracted from healthy porcine cartilage tissues.


product details



Test Items


Company Specification

CP

EP

USP

Characters

White or almost white powder, hygroscopic

White or almost white powder, hygroscopic

Identification

IR graph: Conforms

IR graph: Conforms

IR graph: Conforms

Sodium: Conforms

Sodium: Conforms

Sodium: Conforms

————

Electrophoresis: Conforms

Disaccharide composition: Conforms

Tests

Clarity

————

————

Clear: A420 ≤ 0.35 (5%)

Specific Rotation

-25°~ -32°

-20~ -305%

-20~ -30(30mg/ml)

Intrinsic viscosity

————

0.01~0.15m3/kg

————

Related substances

————

Conforms

Conforms

pH

6.0~7.0

5.5~7.5(5%)

5.5~7.5(1%)

Loss on drying

≤ 10.0%(105℃ 4h)

≤ 12.0%(105℃ 4h)

≤ 12.0%(105℃ 4h)

Residue on ignition

20.0%~30.0%(dry substance)

————

20.0%~30.0%(dry substance)

Chloride

≤ 0.5%

≤ 0.5%

≤ 0.5%

Sulfate

≤ 0.24%

————

≤ 0.24%

Heavy metal

≤ 20ppm

≤ 20ppm

≤ 20ppm

Electrophoreic Purity

————


Conforms

Protein

————

≤ 3.0%(dry substance)

≤ 6.0%(dry substance)

Residual solvent

Conforms

Conforms

Conforms

Nonspecific disaccharides

————


≤ 10.0%

Content

90.0~105.0%(dry substance)

95.0~105.0% (dry substance)

90.0~105.0%(dry substance)

Microbial Impurities

TAMC

≤ 1000cfu/g

≤ 1000cfu/g

≤ 1000cfu/g

TYMC

≤ 100cfu/g

≤ 100cfu/g

≤ 100cfu/g

E.coli

Conforms

Conforms

Conforms

Salmonella

Conforms

Conforms

Conforms

Staphylococcus aureus

————

Conforms

————

Pseudomonas aeruginosa

————

Conforms

————

Bile-Tolerant Gram-Negative Bacteria

————

≤ 100cfu/g

————




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