Aspartame

Aspartame is an artificial non-saccharide sweetener 200 times sweeter than sucrose and is commonly used as a sugar substitute in foods and beverages. t is a methyl ester of the aspartic acid/phenylalanine dipeptide. Aspartame is approved for use in food products by most countries. It has an E number of E951.

Properties and General Specifications of Aspartame or Asp-Phe methyl ester:
Appearance: White solid.
Assay: 99% minimum.
Odor: Odorless
Melting point: 246C - 247C
Boiling point: decomposes.
Relative density: 1.35
Solubility: Sparingly soluble; Slightly soluble in ethanol.

Aspartame USP NF Grade:
C14H18N2O5 --- 294.30
L-Phenylalanine, N-L- -aspartyl-, 1-methyl ester.
3-Amino-N-( -carboxyphenethyl)succinamic acid N-methyl ester --- 22839-47-0.

Aspartame contains not less than 98.0 percent and not more than 102.0 percent of C14H18N2O5, calculated on the dried basis.

Packaging and storage: Preserve in well-closed containers.
Identification: Do not dry specimens.
Transmittance: The transmittance of a 1 in 100 solution of it in 2 N hydrochloric acid, prepared by means of sonication, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, is not less than 0.95, corresponding to an absorbance of not more than about 0.022.
Specific rotation: between +14.5 and +16.5 , determined at 20 within 30 minutes after preparation of the solution.
Test solution: 40 mg per mL, in 15 N formic acid.
Loss on drying: Dry it at 105 for 4 hours: it loses not more than 4.5% of its weight.
Residue on ignition: not more than 0.2%.
Heavy metals: 0.001%.
Limit of 5-benzyl-3,6-dioxo-2-piperazineacetic acid: To pass the test.
Chromatographic purity: To pass the test --- corresponding to not more than 2.0% of chromatographic impurities.
Assay:
0.1 N Perchloric acid: Use perchloric acid, tenth-normal (in glacial acetic acid) as specified under Volumetric Solutions in the section Reagents, Indicators, and Solutions, but in the standardization, titrate to a green endpoint.
Procedure: Transfer about 300 mg of Aspartame, accurately weighed, to a 150-mL beaker, dissolve in 1.5 mL of anhydrous formic acid, and add 60 mL of glacial acetic acid. Add crystal violet, and immediately titrate with 0.1 N Perchloric acid to a green endpoint. Perform a blank determination and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 29.43 mg of C14H18N2O5. [NOTE—A blank titration exceeding 0.1 mL may be due to excessive water content and may cause loss of visual endpoint sensitivity.].

Specifications of Aspartame BP Ph Eur Grade:
C14H18N2O5 --- 294.3 --- 22839-47-0
Action and use: Sweetening agent.

DEFINITION
(3S)-3-Amino-4-[[(2S)-1-methoxy-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid (methyl α-L-aspartyl-L-phenylalaninate).
Content: 98.0 per cent to 102.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, slightly hygroscopic, crystalline powder.
Solubility: Sparingly soluble or slightly soluble in water and in ethanol (96 per cent), practically insoluble in hexane and in methylene chloride.

IDENTIFICATION
First identification: B
Second identification: A, C, D
A. Ultraviolet and visible absorption spectrophotometry.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.
D. Dissolve about 20 mg in 5 mL of methanol and add 1 mL of alkaline hydroxylamine solution. Heat on a water-bath for 15 min. Allow to cool and adjust to about pH 2 with dilute hydrochloric acid. Add 0.1 mL of ferric chloride solution. A brownish-red colour is produced.

TESTS
Solution S: Dissolve 0.8 g in carbon dioxide-free water and dilute to 100 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Conductivity: Maximum 30 microS/cm. To pass the test.
Specific optical rotation: + 14.5 to + 16.5 (dried substance).
Related substances: To pass the test.
Loss on drying: Maximum 4.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.2 per cent, determined on 1.0 g.

ASSAY
Dissolve 0.250 g in 1.5 mL of anhydrous formic acid and 60 mL of anhydrous acetic acid. Titrate immediately with 0.1 M perchloric acid, determining the end point potentiometrically.
1 mL of 0.1 M perchloric acid is equivalent to 29.43 mg of C14H18N2O5.

STORAGE
In an airtight container.

Specifications of Aspartame FCC Food Grade:
N-L-alpha-Aspartyl-L -phenylalanine 1-Methyl Ester; APM
C14H18N2O5 Formula weight 294.31
INS: 951 CAS: [22839-47-0]

DESCRIPTION
Aspartame occurs as a white, crystalline powder. It is sparingly soluble in water and slightly soluble in alcohol. The pH of a 0.8% solution is between about 4.5 and 6.0.
Function: Sweetener; sugar substitute; flavor enhancer.
REQUIREMENTS
Identification: The infrared absorption spectrum of a potassium bromide dispersion of sample exhibits maxima only at the same wavelengths as those of a similar preparation of USP Aspartame Reference Standard.
Assay: Not less than 98% and not more than 102% of C14H18N2O5, calculated on the dried basis.
5-Benzyl-3,6-dioxo-2-piperazineacetic Acid: Not more than 1.5%.
Lead: Not more than 1 mg/kg.
Loss on Drying: Not more than 4.5%.
Optical (Specific) Rotation [alpha]D20°: Between +14.5° and +16.5°, calculated on the dried basis.
Other Related Substances: Not more than 2.0%.
Residue on Ignition: Not more than 0.2%.

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.