Insoluble Saccharin n Saccharin Sodium USP NF BP Ph Eur FCC Food Grade Manufacturers Exporters

Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturers of Insoluble Saccharin n Saccharin Sodium, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in 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, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc.

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Insoluble Saccharin: CAS Number: 81-07-2, EINECS EC Number: 201-321-0, Molecular Formula: C7H5NO3S, Molecular Weight: 183.18

Sodium Saccharin: CAS Number: 82385-42-0, EINECS EC Number: 204-886-1, Molecular Formula: C7H4NNaO3S-xH2O, Molecular Weight: 205.17 (anhydrous)

Saccharin USP NF Grade
C7H5NO3S 183.19
1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide.
1,2-Benzisothiazolin-3-one 1,1-dioxide [81-07-2].
Saccharin contains not less than 99.0 percent and not more than 101.0 percent of C7H5NO3S, calculated on the dried basis.

Clarity of solution: [NOTE: The Test solution is to be compared to Reference suspension A and to water in diffused daylight 5 minutes after preparation of Reference suspension A.]
Hydrazine solution: Transfer 1.0 g of hydrazine sulfate to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Allow to stand for 4 to 6 hours.
Methenamine solution: Transfer 2.5 g of methenamine to a 100-mL glass-stoppered flask, add 25.0 mL of water, insert the glass stopper, and mix to dissolve.
Primary opalescent suspension: [NOTE: This suspension is stable for 2 months, provided it is stored in a glass container free from surface defects. The suspension must not adhere to the glass and must be well mixed before use.] Transfer 25.0 mL of Hydrazine solution to the Methenamine solution in the 100-mL glass-stoppered flask. Mix, and allow to stand for 24 hours.

Opalescence standard: [NOTE: This suspension should not be used beyond 24 hours after preparation.] Transfer 15.0 mL of the Primary opalescent suspension to a 1000-mL volumetric flask, dilute with water to volume, and mix.
Reference suspensions: Transfer 5.0 mL of the Opalescence standard to a 100-mL volumetric flask, dilute with water to volume, and mix to obtain Reference suspension A. Transfer 10.0 mL of the Opalescence standard to a second 100-mL volumetric flask, dilute with water to volume, and mix to obtain Reference suspension B.
Test solution: Dissolve 5.0 g of test material in about 20 mL of a 200 g per L solution of sodium acetate, dilute with the same solution to 25 mL, and mix.
Procedure: Transfer a sufficient portion of the Test solution to a test tube of colorless, transparent, neutral glass with a flat base and an internal diameter of 15 mm to 25 mm to obtain a depth of 40 mm.
Similarly transfer portions of Reference suspension A, Reference suspension B, water, and a 200 g per L solution of sodium acetate to separate matching test tubes. Compare the Test solution, Reference suspension A, Reference suspension B, water, and a 200 g per L solution of sodium acetate in diffused daylight, viewing vertically against a black. [NOTE—The diffusion of light must be such that Reference suspension A can readily be distinguished from water and that Reference suspension B can readily be distinguished from Reference suspension A.] The Test solution shows the same clarity as that of water, or the 200 g per L solution of sodium acetate, or its opalescence is not more pronounced than that of Reference suspension A.

Color of solution:
Standard stock solution: Combine 3.0 mL of ferric chloride, 3.0 mL of cobaltous chloride, 2.4 mL of cupric sulfate, and 1.6 mL of dilute hydrochloric acid (10 g per L).
Standard solution: [NOTE: Prepare the Standard solution immediately before use.] Transfer 1.0 mL of Standard stock solution to a 100-mL volumetric flask, dilute with dilute hydrochloric acid (10 g per L) to volume, and mix.
Test solution: Use the Test solution from Clarity of solution.
Procedure: Transfer a sufficient portion of the Test solution to a test tube of colorless, transparent, neutral glass with a flat base and an internal diameter of 15 mm to 25 mm to obtain a depth of 40 mm.
Similarly transfer portions of the Standard solution, a 200 g per L solution of sodium acetate, and water to separate matching test tubes. Compare the Test solution, the Standard solution, a 200 g per L solution of sodium acetate, and water in diffused daylight, viewing vertically against a white background. The Test solution has the appearance of water or the 200 g per L solution of sodium acetate, or is not more intensely colored than the Standard solution.

Identification: Infrared Absorption 197K .
Melting range: between 226C and 230C.
Loss on drying: Dry it at 105C for 2 hours: it loses not more than 1.0% of its weight.
Readily carbonizable substances: Dissolve 200 mg in 5 mL of sulfuric acid (between 94.5% and 95.5% [w/w] of H2SO4), and keep at a temperature of 48C to 50C for 10 minutes: the solution has no more color than Matching Fluid A, when viewed against a white background.
Residue on ignition: not more than 0.2%. Ignition temperature: 600C ± 50C.
Heavy metals: 0.001%.
Limit of toluenesulfonamides:
Internal standard solution: Dissolve 25 mg of caffeine in methylene chloride, and dilute with the same solvent to 100 mL.
Reference solution: Dissolve 20.0 mg of USP o-Toluenesulfonamide and 20.0 mg of USP p-Toluenesulfonamide in methylene chloride, and dilute with the same solvent to 100.0 mL. Dilute 5.0 mL of the solution with methylene chloride to 50.0 mL. Evaporate 5.0 mL of the final solution to dryness in a stream of nitrogen. Dissolve the residue in 1.0 mL of the Internal standard solution.
Test solution: Suspend 10.0 g of the substance to be examined in 20 mL of water, and dissolve using 5 mL to 6 mL of 10 N sodium hydroxide. If necessary, adjust the solution with 1 N sodium hydroxide or 1 N hydrochloric acid to a pH of 7 to 8, and dilute with water to 50 mL. Shake the solution with four quantities each of 50 mL of methylene chloride. Combine the lower layers, dry over anhydrous sodium sulfate, and filter. Wash the filter and the sodium sulfate with 10 mL of methylene chloride. Combine the solution and the washings, and evaporate almost to dryness in a water bath at a temperature not exceeding 40C. Using a small quantity of methylene chloride, quantitatively transfer the residue into a suitable 10-mL tube, evaporate to dryness in a stream of nitrogen, and dissolve the residue in 1.0 mL of the Internal standard solution.
Blank solution: Evaporate 200 mL of methylene chloride to dryness in a water bath at a temperature not exceeding 40C. Dissolve the residue in 1 mL of methylene chloride.
Chromatographic system: The gas chromatograph is equipped with a flame-ionization detector and contains a 0.53-mm × 10-m fused silica column, coated with G3 phase (film thickness 2 Gm). The injection port, column, and detector temperatures are maintained at about 250C, 180C, and 250C, respectively; and nitrogen is used as the carrier gas at a flow rate of about 10 mL per minute. The injector employs a split ratio of 1:2.
Procedure: Inject about 1 GL of the Reference solution. Adjust the sensitivity of the detector so that the height of the peak due to caffeine is not less than 50% of the full scale of the recorder. The substances are eluted in the following order: o-toluenesulfonamide, p-toluenesulfonamide, and caffeine. The test is not valid unless the resolution between the peaks due to o-toluenesulfonamide and p-toluenesulfonamide is at least 1.5. Inject about 1 GL of the Blank solution. In the chromatogram obtained, verify that there are no peaks with the same retention times as the internal standard, otoluenesulfonamide, and p-toluenesulfonamide. Inject about 1 GL of the Test solution and 1 GL of the Reference solution. If any peaks due to o-toluenesulfonamide, and p-toluenesulfonamide appear in the chromatogram obtained with the Test solution, the ratio of their areas to that of the internal standard is not greater than the corresponding ratio in the chromatogram obtained with the Reference solution (10 ppm of o-toluenesulfonamide and 10 ppm of p-toluenesulfonamide).

Limit of benzoate and salicylate: To 10 mL of a hot, saturated solution of it add ferric chloride, dropwise: no precipitate or violet color appears in the liquid.

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.

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 1 N 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 226° 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%.

Specifications of Saccharin Sodium USP Grade:
C7H4NNaO3S-2H2O --- 241.20
C7H4NNaO3S --- 205.17
1,2-Benzisothiazol-3(2H )-one, 1,1-dioxide, sodium salt, dihydrate;
1,2-Benzisothiazolin-3-one 1,1-dioxide sodium salt dihydrate CAS 6155-57-3.
Anhydrous CAS 128-44-9.

DEFINITION
Saccharin Sodium contains NLT 99.0% and NMT 101.0% of saccharin sodium (C7H4NNaO3S), calculated on the anhydrous basis.

IDENTIFICATION
A. Infrared Absorption.
B. Procedure:
Sample solution: 100 mg/mL
Potassium pyroantimonate solution: Dissolve 2 g of potassium pyroantimonate in 95 mL of hot water. Cool quickly and add 50 mL of a potassium hydroxide solution (50 mg/mL) and 1 mL of sodium hydroxide solution (8.5 in 100). Allow to stand for 24 h, filter, and dilute with water to 150 mL.
Analysis: To 10 mL of the Sample solution add 2 mL of 15% potassium carbonate, and heat to boiling. No precipitate is formed. Add 4 mL of Potassium pyroantimonate solution, and heat to boiling. Allow to cool in ice water and, if necessary, rub the inside of the test tube with a glass rod.
Acceptance criteria: A dense precipitate is formed.
C. Sodium salts impart an intense yellow color to a nonluminous flame.

ASSAY
Procedure:
Sample solution: Dissolve 150 mg of Saccharin Sodium in 50 mL of glacial acetic acid. [Note: Slight heating may be needed to dissolve the sample.]
Analysis: Titrate the Sample solution with 0.1 N perchloric acid, determining the endpoint potentiometrically. Perform a blank determination and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 20.52 mg of saccharin sodium (C7H4NNaO3S).
Acceptance criteria: 99.0%–101.0% on the anhydrous basis

Limit of Toluenesulfonamides: to pass the test by Chromatography.
Acceptance criteria: If any peaks due to o-toluenesulfonamide and p-toluenesulfonamide appear in the chromatogram of the Sample solution, the ratio of their areas to that of caffeine (internal standard) is NMT the corresponding ratio in the chromatogram of the Standard solution.
Individual impurities:
o-Toluenesulfonamide: 10 ppm.
p-Toluenesulfonamide: 10 ppm.
Limit of Benzoate and Salicylate:
Sample solution: 50 mg/mL
Analysis: To 10 mL of the Sample solution add 5 drops of 6 N acetic acid, and then add 3 drops of ferric chloride.
Acceptance criteria: No precipitate or violet color appears.
Water Determination: NMT 15.0%
Readily Carbonizable Substances: To pass the test.
Acidity or Alkalinity:
Sample solution: 100 mg/mL in carbon dioxide-free water
Analysis: To 10 mL of the Sample solution add 1 drop of PhPh.
Acceptance criteria: No red or pink color is produced. Then add 1 drop of 0.1 N sodium hydroxide: a red or pink color is produced.
Clarity of Solution: To pass the test.
Acceptance criteria: The Sample solution shows the same clarity as that of water, or its opalescence is NMT that of Reference suspension.
Color of Solution: To pass the test.
Acceptance criteria: The Sample solution has the appearance of water or is not more intensely colored than the Standard solution.

Saccharin Sodium BP Grade
Soluble Saccharin
Ph Eur
C7H4NNaO3Sii205.2ii128-44-9
Action and use: Sweetening agent.

DEFINITION
2-Sodio-1,2-benzisothiazol-3(2H)-one 1,1-dioxide.
Content: 99.0 per cent to 101.0 per cent (anhydrous substance). It may contain a variable quantity of water.

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals, efflorescent in dry air.
Solubility: Freely soluble in water, sparingly soluble in ethanol (96 per cent).

IDENTIFICATION
First identificationiB, E.
Second identificationiA, C, D, E.
A. Melting point: 226C to 230C.
To 5 ml of solution S (see Tests) add 3 ml of dilute hydrochloric acid. A white precipitate is formed. Filter and wash with water. Dry the precipitate at 100-105 °C.
B. Infrared absorption spectrophotometry.
C. Mix about 10 mg with about 10 mg of resorcinol, add 0.25 ml of sulphuric 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.
D. 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.
E. Solution S gives reaction (a) of sodium.

TESTS
Solution S: Dissolve 5.0 g in carbon dioxide-free water and dilute to 50.0 ml with the same solvent.
Appearance of solution: The solution is clear and colourless.
Dissolve 5.0 g in 25 ml of carbon dioxide-free water.
Acidity or alkalinity: To 10 ml of solution S add about 0.05 ml of a 10 g/l solution of PhPh in ethanol (96 per cent). The solution is not pink. Add 0.1 ml of sodium hydroxide 0.1 M. The solution becomes pink.
o- and p-Toluenesulphonamide: Gas chromatography to pass the test.
Readily carbonisable substances: Dissolve 0.20 g in 5 ml of sulphuric 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.
Heavy metals: Maximum 20 ppm.
Water: Maximum 15.0 per cent, determined on 0.200 g.

Sodium Saccharin FCC Food Grade
1,2-Benzisothiazole-3(2H)-one 1,1-Dioxide Sodium Salt;
Sodium o-Benzosulfimide; Soluble Saccharin
C7H4NNaO3S·2H2O --- Formula wt 241.19
INS: 954 CAS: [128-44-9]

DESCRIPTION
Sodium Saccharin occurs as white crystals or as a white, crystalline powder. In powdered form, it effloresces to the extent that it usually contains only about one-third the amount of water indicated in its molecular formula. One gram is soluble in 1.5 mL of water and in about 50 mL of alcohol.
Function: Nonnutritive sweetener.

REQUIREMENTS
Identification:
A. Dissolve about 100 mg of sample in 5 mL of a 1:20 solution of sodium hydroxide, evaporate 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 1 N sodium hydroxide. A fluorescent green liquid results.
C. The residue obtained by igniting a 2-g sample gives positive tests for Sodium.
D. Add 1 mL of hydrochloric acid to 10 mL of a 1:10 aqueous solution. A crystalline precipitate of saccharin forms. Wash the precipitate well with cold water, and dry at 105C for 2 h. The saccharin thus obtained melts between 226C and 230C.
Assay: Not less than 98.0% and not more than 101.0% of C7H4NNaO3S, calculated on the anhydrous basis.
Alkalinity: Passes test.
Benzoate and Salicylate: Passes test.
Lead: Not more than 2 mg/kg.
Readily Carbonizable: Substances Passes test.
Selenium: Not more than 0.003%.
Toluenesulfonamides: Not more than 0.0025%.
Water: Not more than 15.0%.

CAS Number 81-07-2 & 82385-42-0Insoluble Saccharin n Saccharin Sodium USP NF BP Ph Eur FCC Food Grade manufacturers suppliers exporters at:

manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.