Medical device grade sodium hyaluronate
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1 Medical device grade sodium hyaluronate
SH-MDE.
Function: Good moisturizing property, high hydration, lubrication, inhibition of inflammatory reaction, etc.
Applications: oral ulcers, oral tissue wound healing treatment aids, body cavity instrument introduction lubricants, aids in improving pathologic skin scars, etc.
SPEC
|
Test Items |
Standard |
Test Items |
Standard |
|
White or almost white powder or granule |
Iron/（mg/kg） |
≤ 80 |
|
|
Identification |
A.Infrared absorption spectrophotomet |
Bacteria counts/（CFU/g） |
≤100 |
|
B.It gives reaction(a)of sodium |
Molds and yeasts（CFU/g） |
≤50 |
|
|
Loss on drying |
≤15.0% |
Staphylococcus aureus/g |
Negative |
|
Intrinsic viscosity/ （m³/kg） |
Measured value |
Pseudomonas aeruginosa/g |
Negative |
|
Molecular weight/（Da） |
Measured value |
Bacterial endotoxins/（IU/mg） |
<0.5 |
|
pH |
5.0-8.5 |
Hemolysis |
Negative |
|
Nucleic Acid |
A260nm≤ 0.5 |
Hemolytic streptococci |
Negative |
|
Appearance of Solution |
A600nm≤ 0.01 |
Ethanol residues/（ppm） |
≤4000 |
|
Protein/% |
≤0.1 |
Sodium hyaluronate/（%） |
95-105 |
|
Chlorides/% |
≤ 0.5 |
/ |
/ |
SH-MDI:
Function: High viscoelasticity, good biocompatibility and biodegradability
Application: contact lens care solution, ocular viscoelastic agent, injection modification of sodium hyaluronate gel raw materials, hydrographic products, etc.
SPEC
|
Test Items |
Standard |
Test Items |
Standard |
|
White or almost white powder or granule |
Iron/（mg/kg） |
≤ 20 |
|
|
Identification |
A.Infrared absorption spectrophotomet |
Bacteria counts/（CFU/g） |
≤100 |
|
B.It gives reaction(a)of sodium |
Molds and yeasts（CFU/g） |
≤50 |
|
|
Loss on drying |
≤15.0% |
Staphylococcus aureus/g |
Negative |
|
Intrinsic viscosity/ （m³/kg） |
Measured value |
Pseudomonas aeruginosa/g |
Negative |
|
Molecular weight/（Da） |
Measured value |
Bacterial endotoxins/（IU/mg） |
<0.04 |
|
pH |
5.0-8.5 |
Hemolysis |
Negative |
|
Nucleic Acid |
A260nm≤ 0.5 |
Hemolytic streptococci |
Negative |
|
Appearance of Solution |
A600nm≤ 0.01 |
Ethanol residues/（ppm） |
≤4000 |
|
Protein/% |
≤0.05 |
Sodium hyaluronate/（%） |
95-105 |
|
Chlorides/% |
≤ 0.5 |
/ |
/ |
2 Eye drops grade sodium hyaluronate
Function:It has good lubrication, moisturizing and dry eye relief.
Application: For parenteral administration other than intra-articular administration and intra-ocular use.
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