Saccharin USP NF Grade Specifications:
C7H5NO3S --- 183.18
1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide;
1,2-Benzisothiazolin-3-one 1,1-dioxide CAS 81-07-2

DEFINITION
Saccharin contains NLT 99.0% and NMT 101.0% of saccharin (C7H5NO3S), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption.

ASSAY
Procedure
Sample: 500 mg
Analysis: Dissolve the Sample in 40 mL of alcohol. Add 40 mL of water and phenolphthalein. Titrate with 0.1 N sodium hydroxide. Perform a blank titration, if necessary, and make the appropriate correction. Each mL of 0.1 N sodium hydroxide is equivalent to 18.32 mg of saccharin (C7H5NO3S).
Acceptance criteria: 99.0% to 101.0% on the dried basis

Procedure Sample: 500 mg Analysis: Dissolve the Sample in 40 mL of alcohol. Add 40 mL of water and phenolphthalein. Titrate with 0.1 N sodium hydroxide. Perform a blank titration, if necessary, and make the appropriate correction. Each mL of 0.1 N sodium hydroxide is equivalent to 18.32 mg of saccharin (C7H5NO3S). Acceptance criteria: 99.0% to 101.0% on the dried basis

Residue on Ignition: NMT 0.2%, using an ignition temperature of 600±50C Limit of Toluenesulfonamides: To pass the test by Chromatography. o-Toluenesulfonamide: 10 ppm maximum. p-Toluenesulfonamide: 10 ppm maximum.

Limit of Benzoate and Salicylate: Sample solution: 10 mL of a hot, saturated solution of saccharin Analysis: Add ferric chloride TS dropwise to the Sample solution. Acceptance criteria: No precipitate or violet color appears in the liquid.

Melting Range or Temperature: 226C to 230C.

Loss on Drying: Analysis: Dry at 105C for 2 h. Acceptance criteria: NMT 1.0%

Readily Carbonizable Substances: Sample solution: 40 mg/mL in sulfuric acid [94.5% to 95.5% (w/w) of H2SO4]; maintained at 48C to 50C for 10 min. Acceptance criteria: The Sample solution has no more color than Matching Fluid A, when viewed against a white background.

Clarity of Solution: To pass the test.

Color of Solution: To pass the test.

Packaging and Storage: Preserve in well-closed containers. Store at room temperature.

Specifications of Saccharin BP Ph Eur Grade:
C7H5NO3S --- 183.2 --- CAS 81-07-2
Action and use: Sweetening agent.

DEFINITION
1,2-Benzisothiazol-3(2H)-one 1,1-dioxide.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals.
Solubility: Sparingly soluble in boiling water and in ethanol (96 per cent), slightly soluble in cold water. It dissolves in dilute solutions of alkali hydroxides and carbonates.

IDENTIFICATION
First identification: C
Second identification: A, B, D, E
A. A saturated solution, prepared without heating, turns blue litmus paper red.
B. Melting point: 226C to 230C.
C. Infrared absorption spectrophotometry.
Comparison Saccharin CRS.
D. Mix about 10 mg with about 10 mg of resorcinol add 0.25 mL of sulfuric acid and carefully heat the mixture over a naked flame until a dark green colour is produced. Allow to cool, add 10 mL of water and dilute sodium hydroxide solution until an alkaline reaction is produced. An intense green fluorescence develops.
E. To 0.2 g add 1.5 & mL of dilute sodium hydroxide solution evaporate to dryness and heat the residue carefully until it melts, avoiding carbonisation. Allow to cool, dissolve the mass in about 5 mL of water, add dilute hydrochloric acid until a weak acid reaction is produced and filter, if necessary. To the filtrate add 0.2 mL of ferric chloride solution. A violet colour develops.

TESTS
Solution S: Dissolve 5.0 g in 20 mL of a 200 g/L solution of sodium acetate and dilute to 25 mL with the same solution.
Appearance of solution: Solution S is clear and colourless.
o- and p-Toluenesulfonamide: To pass the test by Gas chromatography.
Limits:
-o-toluenesulfonamide: the ratio of its area to that of the internal standard is not greater than the corresponding ratio in the chromatogram obtained with the reference solution (10 ppm),
-p-toluenesulfonamide: the ratio of its area to that of the internal standard is not greater than the corresponding ratio in the chromatogram obtained with the reference solution (10 ppm).
Readily carbonisable substances: Dissolve 0.20 g in 5 mL of sulfuric acid and keep at 48-50C for 10 min. When viewed against a white background, the solution is not more intensely coloured than a solution prepared by mixing 0.1 mL of red primary solution, 0.1 mL of blue primary solution and 0.4 mL of yellow primary solution with 4.4 mL of water.
Loss on drying: Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105C for 2 h.
Sulfated ash: Maximum 0.2 per cent, determined on 1.0 g.

Specifications of Saccharin FCC Food Grade
o-Benzosulfimide; Gluside; 1,2-Benzisothiazole-3(2H)-one-1,1-dioxide
C7H5NO3S Formula wt 183.18
INS: 954 CAS: 81-07-2

DESCRIPTION
Saccharin occurs as white crystals or as a white, crystalline powder. Its solutions are acid to litmus. One gram is soluble in 290 mL of water at 25C, in 25 mL of boiling water, and in 30 mL of alcohol. It is slightly soluble in chloroform and in ether, and it is readily dissolved by dilute solutions of ammonia, solutions of alkali hydroxides, or solutions of alkali carbonates with the evolution of carbon dioxide.
Function: Nonnutritive sweetener.

REQUIREMENTS
Identification:
A. Dissolve about 100 mg of sample in 5 mL of a 1:20 solution of sodium hydroxide, evaporate the mixture to dryness and gently fuse the residue over a small flame until ammonia no longer evolves. After the residue has cooled, dissolve it in 20 mL of water, neutralize the solution with 2.7 N hydrochloric acid, and filter. Add 1 drop of ferric chloride to the filtrate. A violet color appears.
B. Mix 20 mg of sample with 40 mg of resorcinol, cautiously add 10 drops of sulfuric acid, and heat the mixture in a liquid bath at 200C for 3 min. After cooling, add 10 mL of water and an excess of 1N sodium hydroxide. A fluorescent green liquid results.
Assay: Not less than 98.0% and not more than 101.0% of C7H5NO3S after drying.
Benzoic and Salicylic Acids: Passes test.
Lead: Not more than 2 mg/kg.
Loss on Drying: Not more than 1%.
Melting Range: Between 226C and 230C.
Readily Carbonizable Substances: Passes test.
Residue on Ignition: Not more than 0.2%.
Selenium: Not more than 0.003%.
Toluenesulfonamides: Not more than 0.0025%.