Sodium hyaluronate viscoelastic solution for ophthalmic surgery

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Overview
Quick Details
CAS No.:
9004-61-9, 9004-61-9
Other Names:
sodium hyaluronate
MF:
C28H44N2O23, (C14H21NO117)n
EINECS No.:
232-678-0
Place of Origin:
Shandong, China
Type:
Anesthetic Agents, Anti-Allergic Agents
Grade Standard:
Medicine Grade, injection grade, food grade,pharmaceutical grade,cosmetic grade
Brand Name:
Roc
Model Number:
injection for ophthalmic surgery
Purity:
high purity
Other name:
Sodium Hyaluronate
Appearance:
white or off-white powder
Function:
viscoelastic protective agent to assist the ophthalmic surgery
Shelf-life:
24months
Tech:
microbial fermented
Assay:
99% Min
Ingredients:
D-Glucuronic Acid
Supply Ability
Supply Ability:
10 Metric Ton/Metric Tons per Year
Packaging & Delivery
Packaging Details
1kg per aluminium foil bag , outer with 25kg fiber drum ;
Or as per customers' instruction .
Port
Qindao
Lead Time :
Within 3 days

Sodium hyaluronate viscoelastic solution for ophthalmic surgery

 

Cas No.: 9004-61-9

EINECS No: 232-678-0

Molecular formula: C28H 44N2O23

 

 

Brief introduction of Hyaluronic Acid ( HA )

Extracted Hyaluronic Acid is extracted from rooster combs.It is very similar to the natural Hyaluronic Acid in human body.Naturalness,activity,low molecular weight and easy absorbed make Extracted Hyaluronic Acid very popular in the Nutritional Supplyment and Cosmetics manufacturing industries in Europe,America,Japan and Korea.

 

 

Medical / Pharmaceutical / Injection grade 

Hyaluronic Acid ( HA ) / Sodium Hyaluronate for ophthalmic surgery

This product, being animal-origin free and with high viscoelasticity, lubricity, physical alterability and good biocompatibility, are medical polymer materials extracted and refined by high-tech bio-engineering from streptococcal fermentation metabolites.

 

Composed by high purified hyaluronic sodium and physiogical buffer ,and is of colorless and transparent gelatinous solution Hyaluronic sodium can well lubricate cell layer to protect tissue from being damaged by surgical instruments.

 

 

Character:

High-purity ,high viscoelastic,high transparent can maintain a clear surgical environment ,it is a perfect viscoelastic protective agent to assist the ophthalmic surgery

 

Overview:

By putting into the anterior chamber,the HA absorbed will vibrate and lubricate the cell layer,preventing the tissue from being damaged from surgical instruments,and its molecular structure cam maitain a good surgical space and its high degree of transparency can maintain a good surgical space and its high degree of transparency can maitain a good vision for the operation.

 

 

 

          Certificate of Analysis of Pharmaceutical Intermediate  HA

 

Test Items

Standard

 

Result

 

Appearance

 

White powder or granules

 

 

White powder or granules

 

Sodium Hyaluronate

95 to 105% (w/w,on dry basis)

99.9%

 

Glucuronic Acid

42.0% min

43.54%

 

Molecular Weight

1.80 × 106Da min

1.96 × 106Da

 

limiting Viscosity

25.0 dl/g min

29.0 dl/g

 

PH

5.0-8.5

6.7

 

Absorbance (260nm wavelength)

 

 

0.5 max

Complies

 

Loss On Drying

10.0% max

8.9%

 

Protein

0.1% max

0.02%

 

Chlorides

0.5% max

0.32%

 

Iton

80ppm max

Complies

 

Arsenic

2ppm max

Complies

Heavy metal

10ppm max

Complies

Microbe Counts

Less Than 10cfu/g

Complies

 

Endotoxin

0.5IU/mg max

0.4IU/mg

Staphylococcus Aureus

Negative

Negative

 

Pseudomonas Aeruginosa

Negative

Negative

 

Storage Condition

 

Shields light the airtight 0-8°C preservation

 

Shelf Life

   

Two Years

 

Conclusion

 

The results meet the standard USP/31/BP2009/EP6.0