Sodium Alginate

Sodium Alginate BP Ph Eur Grade Specifications
Ph Eur
Action and use: Excipient.

DEFINITION
Sodium alginate consists mainly of the sodium salt of alginic acid, which is a mixture of polyuronic acids [C6H8O6)n] composed of residues of D-mannuronic acid and L-guluronic acid. Sodium alginate is obtained mainly from algae belonging to the Phaeophyceae.

CHARACTERS
Appearance: White or pale yellowish-brown powder.
Solubility: Slowly soluble in water forming a viscous, colloidal solution, practically insoluble in ethanol (96 per cent).

IDENTIFICATION
A. Dissolve 0.2 g with shaking in 20 ml of water. To 5 ml of this solution add 1 ml of calcium chloride solution. A voluminous gelatinous mass is formed.
B. To 10 ml of the solution prepared in identification test A add 1 ml of dilute sulphuric acid. A gelatinous mass is formed.
C. To 5 mg add 5 ml of water, 1 ml of a freshly prepared 10 g/l solution of 1,3-dihydroxynaphthalene in ethanol (96 per cent) and 5 ml of hydrochloric acid. Boil for 3 min, cool, add 5 ml of water, and shake with 15 ml of di-isopropyl ether. Carry out a blank test. The upper layer obtained with the substance to be examined exhibits a deeper bluish-red colour than that obtained with the blank.
D. It complies with the test for sulphated ash. The residue obtained, dissolved in 2 ml of water, gives reaction (a) of sodium.

TESTS
Solution S: Dissolve 0.10 g in water, with constant stirring, dilute to 30 ml with the same solvent and allow to stand for 1 h.
Appearance of solution: The solution is not more opalescent than reference and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour.
Dilute 1 ml of solution S to 10 ml with water R.
Chlorides: Maximum 1.0 per cent.
Calcium: Maximum 1.50 per cent.
Heavy metals: Maximum 20 ppm.
Loss on drying: Maximum 15.0 per cent, determined on 0.1000 g by drying in an oven at 105C for 4 h.
Sulphated ash: 30.0 per cent to 36.0 per cent (dried substance), determined on 0.1000 g.
Microbial contamination: Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate-count. It complies with the tests for Escherichia coli and Salmonella.

Sodium Alginate FCC Food Grade
Algin
(C6H7O6Na)n Equiv weight, calculated 198.11
Equiv weight, actual (avg.) 222.00
INS: 401 CAS 9005-38-3]

DESCRIPTION
Sodium Alginate occurs as a white to yellow-brown, fibrous or granular powder. It is the sodium salt of alginic acid. It dissolves in water to form a viscous, colloidal solution. It is insoluble in alcohol and in hydroalcoholic solutions in which the alcohol content is greater than about 30% by weight. It is insoluble in chloroform, in ether, and in acids having a pH lower than about 3.
Function: Stabilizer; thickener; emulsifier; gelling agent.

REQUIREMENTS
Identification: -
A. Add 1 mL of calcium chloride to 5 mL of a 1:100 aqueous solution. A voluminous, gelatinous precipitate forms.
B. Add 1 mL of 2 N sulfuric acid to 10 mL of a 1:100 aqueous solution. A heavy, gelatinous precipitate forms.
C. Place about 5 mg of sample into a test tube, add 5 mL of water, 1 mL of a freshly prepared 1:100 naphtholresorcinol:ethanol solution, and 5 mL of hydrochloric acid. Heat the mixture to boiling, boil gently for about 3 min, and then cool to about 15C. Transfer the contents of the test tube to a 30-mL separator with the aid of 5 mL of water, and extract with 15 mL of isopropyl ether. Perform a blank determination and make any necessary correction. The isopropyl ether extract from the sample exhibits a deeper purple hue than that from the blank.
Assay: A sample yields not less than 18.0% and not more than 21.0% of carbon dioxide (CO2), corresponding to between 90.8% and 106.0% of Sodium Alginate (equiv wt 222.00).
Arsenic: Not more than 3 mg/kg.
Lead: Not more than 5 mg/kg.
Loss on Drying: Not more than 15.0%.

We also produce Sodium Alginate IP Grade.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.