1. Characters: White or almost white powder, hygroscopic.
2. Extraction Source: Porcine cartilage tissues such as throat bone, nasal bone, trachea.
3. process: Chondroitin Sulfate Sodium is extracted from healthy porcine cartilage tissues.
4. Indications and uses: This product can be used for neuropathic pain, migraine headaches, joint pain, adjuvant treatment of high blood cholesterol, can also be used for prevention and treatment of coronary atherosclerotic disease, blood and cholesterol rise, angina, neuralgia, myocardial ischemia, atherosclerosis, but also can be used as additive in food and health-food.
·Passed the Chinese GMP
·27 years of biological enzyme R&D history
·Raw materials are traceable
·Comply with CP、EP、USP and customer standard
·Export to over 30 countries and regions
·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.
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。~ -30。(5%) |
-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 |
———— |