Crystal Clear Products Ankleshwar India
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.org

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Sodium Hyaluronate Specifications of Commercial Pure & BP Ph Eur USP NF Grade Manufacturers & Exporters

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Sodium Hyaluronate Suppliers Manufacturers
Sodium Hyaluronate CAS Number 9067-32-7

Specifications of Sodium Hyaluronate BP Ph Eur Grade:
(C14H20NNaO11) --- CAS 9067-32-7
Action and use: High viscosity mucopolysaccharide.

DEFINITION
Sodium salt of hyaluronic acid, a glycosaminoglycan consisting of D-glucuronic acid and N-acetyl-D-glucosamine disaccharide units. It is extracted from cocks' combs or obtained by fermentation from Streptococci, Lancefield Groups A and C.
Content: 95.0 per cent to 105.0 per cent (dried substance).
Intrinsic viscosity: 90 per cent to 120 per cent of the value stated on the label.

PRODUCTION
Where applicable, the animals from which sodium hyaluronate is derived must fulfil the requirements for the health of animals suitable for human consumption.
When produced by fermentation of gram-positive bacteria, the process must be shown to reduce or eliminate pyrogenic or inflammatory components of the cell wall.

CHARACTERS
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. Infrared absorption spectrophotometry.
Comparison Ph. Eur. reference spectrum of sodium hyaluronate.
B. It gives reaction (a) of sodium.

TESTS
Solution S: Weigh a quantity of the substance to be examined equivalent to 0.10 g of the dried substance and add 30.0 mL of a 9 g/L solution of sodium chloride. Mix gently on a shaker until dissolved (about 12 h).
Appearance of solution: Solution S is clear and its absorbance at 600 nm is not greater than 0.01.
pH: 5.0 to 8.5.Dissolve the substance to be examined in carbon dioxide-free water R to obtain a solution containing a quantity equivalent to 5 mg of the dried substance per millilitre.
Intrinsic viscosity: To pass the test.
Sulfated glycosaminoglycans: Maximum 1 per cent, i the product is extracted from cocks'combs. To pass the test.
Nucleic acids: To pass the test.
Protein: To pass the test.
Chlorides: Maximum 0.5 per cent.
Iron: Maximum 80 ppm.
Atomic absorption spectrometry: To pass the test.
Loss on drying: Maximum 20.0 per cent, determined on 0.500 g by drying at 100-110C.over diphosphorus pentoxide for 6 h.
Microbial contamination:
TAMC: acceptance criterion 100 CFU/g.
Bacterial endotoxins:
Less than 0.5 IU/mg, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins; less than 0.05 IU/mg, if intended for use in the manufacture of intra-ocular preparations or intra-articular preparations without a further appropriate procedure for the removal of bacterial endotoxins.

Sodium Hyaluronate USP NF Grade can also be offered.

SDS MSDS of Sodium Hyaluronate BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers

Crystal Clear Products and the group companies are manufacturing chemicals since several decades. We have automatic vacuum operated titanium evaporators and SS316 equipments to produce top grade of chemical products. We have toll manufacturers and representatives in China, UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Bangkok Thailand, Kaula Lumpur Malaysia, Dubai UAE etc. & sales representative in Chicago, Houston New York & Los Angeles, USA. Associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified, Crisil Rated.

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Crystal Clear Products
Plot No-C1-1031-9, GIDC Estate, Panoli, Ankleshwar, Gujarat - 393002. India
Telephone Mobile: 91-7506449333; e-mail: info@crystalclearproducts.org

e-mail: info@crystalclearproducts.org

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