Our Product

Shiseido Sodium Hyaluronate Medical Grade
Shiseido Sodium Hyaluronate Products
Product name :
Shiseido Sodium Hyaluronate SZE Grade-EP


Contents

1. Specifications

PROPERTY Specification
Shiseido Ph.Eur. (1472)
Characters-Appearance White or almost white, very hygroscopic powder or fibrous aggregate. White or almost white, very hygroscopic powder or fibrous aggregate.
Characters-Solubility Sparingly soluble or soluble in water, practically insoluble in acetone and in anhydrous ethanol. 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 Examine by infrared absorption spectrophotometry, comparing with the Ph. Eur. Reference spectrum of sodium hyaluronate
Identification B (Na+) It gives reaction (a) of sodium It gives reaction (a) of sodium
Appearance of Solution Solution S is clear, and its absorbance at 600 nm is maximum 0.01 Solution S is clear, and its absorbance at 600 nm is maximum 0.01
pH 5.5 - 7.0 5.0 - 8.5
Intrinsic Viscosity 1.3 - 3.0 m3/kg 90 - 120 % of the value stated on the label
Nucleic Acid Absorbance of solution S at 260 nm is maximum 0.1 Absorbance of solution S at 260 nm is maximum 0.5
Protein ≤ 0.1 % ≤ 0.3 %
≤ 0.1 %*2
Chlorides ≤ 0.1 % ≤ 0.5 %
Iron ≤ 20 ppm ≤ 80 ppm
Heavy Metals ≤ 10 ppm ≤ N/A*5
Loss on Drying ≤ 10.0 % ≤ 20.0 %
Assay 95.0 - 105.0 % 95.0 - 105.0 %
Microbial Limit Test TAMC: ≤ 102 CFU/g
TYMC: ≤ 102 CFU/g
TAMC: ≤ 102 CFU/g
Bacterial Endotoxins < 0.04 IU/mg < 0.5 IU/mg*3
< 0.05 IU/mg*4
Residual solvents Ethanol: ≤ 10,000 ppm
Methanol: ≤ 3,000 ppm
N/A*6
Sulphated glycosaminoglycans*1 N/A ≤ 1 %
*1 Only required by the European Pharmacopeia in the case of being manufactured from cocks’ combs. Shiseido product is obtained by bacterial fermentation.
*2 If intended for use in parenteral administration.
*3 If intended for use in parenteral administration without further removal of bacterial endotoxins.
*4 If intended for use in intra-ocular or intra-articular administration without further removal of bacterial endotoxins.
*5 Heavy metals test was removed from Ph. Eur. (01/2017:1472) as of January 2017
*6 Not listed in by Sodium Hyaluronate monograph of the European Pharmacopoeia.
Note: N/A: Not applicable
Relationship between Intrinsic Viscosity and Molecular Weight
Calculated/Measured molecular weight (MDa)
Relationship Between Intrinsic Viscosity and Molecular Weight Graph - Shiseido Sodium Hyaluronate
Relationship Between Intrinsic Viscosity and Molecular Weight Formula - Shiseido Sodium Hyaluronate
Molecular weight (MW) is a well used index when choosing sodium hyaluronate as a raw material or API. However, Intrinsic viscosity (IV, η) for each batch is requested to be tested according to European monograph, while MW is not.
Here, we must be careful about the fact that calculated MW will be very different depending on the testing methods or the calculation formulas used for calculating MW from IV.
The figure shows how different calculation formulas give difference to MW even though IV is the same.
We use Laurent's equation to calculate values for MW, which match MW that is measured by MALS (Multi Angle Light Scattering) very well.

2. Certificates and compliance

Certificates
  • Japanese GMP Certificate
  • Certificate of Suitability (CEP) to the Sodium Hyaluronate Monograph of the European Pharmacopoeia
Registrations
  • Drug Master File registration with EDQM (European Union)
  • Drug Master File registration with MFDS (South Korea)
  • Drug Master File registration (Type II) with FDA (U.S.)
  • Registration Certificate in Form 41 issued by DCGI (India)
Compliance
  • ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
  • Japanese Drugs / Quasi-drugs GMP Ordinance
  • cGMP
  • EU-GMP
  • Korea Good Manufacturing Practice and Quality Standards compliance
  • ISO14001

3. Uses and applications

Shiseido Sodium Hyaluronate has been used in a wide range of pharmaceutical products and medical devices in the following fields:

Injectable viscosupplements/ Knee injections for Ostheoarthritis (OA)
Injectable dermal fillers for medical aesthetics purpose
Adhesion barrier, anti-adhesion products for surgical use
Injectable ophthalmic viscosurgical devices (OVD) for cataract surgeries
Aqueous eye drops (for treatment of dry eyes)
Contact lens and contact lens solutions
Wound healing
Ointments
and others.

4. Our technology and quality control

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).

In addition, we tightly control bacteria generation by limiting the number of generations of bacteria used for manufacture.

Original Fermentation Technology - Shiseido Hyaluronate
Original Fermentation Technology - Shiseido Hyaluronate
Original Fermentation Technology - Shiseido Hyaluronate
Non-animal origin guaranteed
The culture media and enzymes used to prepare the culture media are of non-animal origins.
Non-Animal Origin Guaranteed Non-Animal Origin Guaranteed
Delivery

Sodium hyaluronate is temperature sensitive, and thus temperature control is a very important factor for quality during delivery. With much experience and research in this area, we are able to propose various delivery conditions based on your needs. Please feel free to contact us for more information.

Shiseido Sodium Hyaluronate Manufacturing Site

5. Packaging and storage conditions

Available package size 10g, 100g
Primary container Polypropylene bottle
Secondary container Heat-sealed aluminium bag
Label Affixed to both primary and secondary containers
Packing and Storage Conditions - Shiseido Sodium Hyaluronate

Storage condition

  • In a refrigerator (2-8°C)
  • In an airtight container, protected from light and humidity

6. Manufacturing Site

Shiseido Sodium Hyaluronate is manufactured in our dedicated plants in Japan, which are designed in compliance with GMP of Japan, Europe, the United States, South Korea, and India.

Since we began operations in 1984, we have been constantly expanding our manufacturing capabilities. In 2018, we started manufacturing Sodium Hyaluronate at our new plant, which is located at the same manufacturing site.

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

Shiseido Sodium Hyaluronate Manufacturing Site

Manufacturing plants dedicated for Shiseido Sodium Hyaluronate

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