Medical Grade

Overview

Shiseido began the production of Sodium Hyaluronate (hereafter referred to as HA) in 1985. Since then, Shiseido has been supplying to many Japanese as well as overseas pharmaceutical companies.
Shiseido's HA is used in various products, such as osteoarthritis visco-supplements, ophthalmic viscoelastic adjuvant, aesthetic surgery adjuvant, eye drops, and adhesion barrier.

GMP Certificate, CEP(Certificate of Suitability to Ph. Eur.) No. R0-CEP 2010-113-Rev-01, Registered DMF with U.S. FDA No. 27291, Registered DMF with Korea FDA No. 20071204-96-E-46-5

Manufacturing site

Shiseido's Sodium Hyaluronate is manufactured domestically in our HA plant designed in compliance with GMP of Japan, Europe and the United States.

Kakegawa Factory Outlook, Streptococcus, Fermentation plant, Purification plant

Manufacturing site
Kakegawa Factory, 1120 Nagaya Kakegawa, Shizuoka, 436-0047, Japan.

Our technology

Original fermentation technology

The production is based on the fermentation technology with Streptococcus, Lancefield Group C, one of the naturally occurring lactic bacteria, and it does not involve genetically modified organism (non-GMO).

Non-animal origin guaranteed

The culture media and enzymes used to prepare the culture media are of non-animal origin.

Certifications and compliance

Certifications

  • Japanese GMP Certificate
  • Certificate of Suitability (CEP) to the Sodium Hyaluronate Monograph of the European Pharmacopoeia

Registration

  • Korean MFDS Drug Master File registration
  • US Drug Master Files

Compliance

  • ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
  • Japan Drugs/Quasi-drugs GMP Ordinance
  • cGMP
  • EU-GMP
  • Korea Good Manufacturing Practice and Quality Standards compliance

Products

Product name: Shiseido Sodium Hyaluronate SZE Grade - EP (Complies with EP monograph)

  Ph. Eur SZE Grade - EP
Appearance White or almost white,
very hygroscopic powder or fibrous aggregate.
Solubility Sparingly soluble or soluble in water,
practically insoluble in acetone and in anhydrous ethanol.
Identification A (IR) Examine by infrared absorption spectrophotometry,
comparing with the Ph. Eur. Reference spectrum of sodium hyaluronate.
Identification B (Na+) It gives reaction (a) of sodium
Appearance of solution Solution S is Clear, and its absorbance at 600 nm is maximum 0.01
pH 5.0 - 8.5 5.5 - 7.0
Intrinsic Viscosity - 0.9 - 3.0 m3/kg
(We have 4 sub ranges)
Nucleic Acid Absorbance of solution S
at 260nm is maximum 0.5
Absorbance of solution S
at 260nm is maximum 0.1
Protein Maximum 0.1% or 0.3% Maximum 0.1%
Chlorides Maximum 0.5% Maximum 0.1%
Iron Maximum 80ppm Maximum 20ppm
Heavy Metals Maximum 10ppm or 20ppm Maximum 10ppm
Loss on Drying Maximum 20.0% Maximum 10.0%
Assay 95.0 - 105.0%
Microbial Limit Test TAMC:
Not more than 100 cfu/g
TAMC:
Not more than 100 cfu/g
TYMC:
Not more than 100 cfu/g
Bacterical Endotoxins Less than 0.05 IU/mg
or 0.5 IU/mg
Less than 0.04 IU/mg

We have other products which comply with JP monograph.
If you want more details, please contact us.

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If you have any questions, please contact us.

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