Altergon Italy R&D labs patented a brand new process for the production of SHYALT ULTRAPURE - Ultrapure Hyaluronic Bulk. The patent recognizes the originality of the process for the production of Hyaluronic Acid for pharmaceutical and medical injectable applications and formulations.
SHYALT ULTRAPURE comes in customizable batch with Molecular Weight between 40 and 3,000 Kda and Intrinsic Viscosity 0.2 - 3.2 m3/kg.
Especially suitable for intra-articular - intraocular use or for the modern concept of Cross-link with high and improved resistance to production thermal treatments.
- Sodium Hyaluronate
- 232-678-0 (Hyaluronic Acid)
|GRADE:||Pharmaceutical / Medical device -High Purification (parenteral administration, including Intra articular, Intra ocular administration) According to the HA monograph (EP monograph c.e.:1472)|
|CERTIFICATION:||CEP: R1-CEP- 2014-263 rev. 00 – GMP CERTIFICATION BY AIFA – MAF FILED TO FDA|
|Mass Weight:||Low, Medium and High Molecular Weight (40KDa - 3000KDa)*|
|Some Characteristics||European Pharmacopoeia Requirements||Altergon Specifications|
|Nucleic acids Absorbance 260 nm (0.33 % solution, dried)||≤ 0.5||≤ 0.02|
|Proteins||≤ 0.1 %||≤ 0.03 %|
|Chlorides||≤ 0.5 %||≤ 0.1 %|
|Iron||≤ 80 ppm||≤ 10 ppm|
|Bacterial endotoxins (Gel Clot)||< 0.05 I.U./mg||< 0.005 I.U./mg|
|Residual of Ethanol (other residual solvents are excluded by the manufacturing process)||≤ 5000 ppm||≤ 1000 ppm|
On Customer request we customize our product according to their technical needs and provide analytical services of Rheological QC in full GMP compliance
It is our pleasure to inform you that the updated version of the MAF for Sodium Hyaluronate has been submitted to FDA on 8th March 2021 with submission number MAF2718/A003.
Certificate of Suitability
We are pleased to inform you that the EDQM has released to Altergon Italia the renewed CEP (R1-CEP- 2014-263 rev. 00) on 22th January 2021.