Erythritol

Erythritol is a type of sugar alcohol. The United States Food and Drug Administration (FDA) approved erythritol for use as a food additive in USA. It has E number E968. Erythritol has the lowest calorie content of any sugar alcohol.

General Specifications of Erythritol Commercial Pure:
Assay: 99.5 – 100.5 %
Lead: 0.5 mg/kg maximum.
Loss on Drying: 0.2 % maximum.
Reducing Sugars (as Glucose): 0.3 % maximum.
Reducing Substances (as D-Glucose): 0.3 % maximum.
Residue on ignition (sulfated ash): 0.1 % maximum.
Conductivity: 20 µS/cm maximum.
Ribitol & Glycerol: 0.1 % maximum.

Specifications of Erythritol BP Ph Eur Grade:
C4H10O4 --- 122.1 --- CAS 149-32-6
Action and use: Excipient.

DEFINITION
(2R,3S)-Butane-1,2,3,4-tetrol (meso-erythritol).
Content: 96.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or free-flowing granules.
Solubility: Freely soluble in water, very slightly soluble in ethanol (96 per cent).

IDENTIFICATION
A. Melting point: 119C to 122C.
B. Infrared absorption spectrophotometry.

TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 5.0 g in water and dilute to 50 mL with the same solvent.
Conductivity: Maximum 20 microS⋅cm-1.
Dissolve 20.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 mL with the same solvent. Measure the conductivity of the solution, while gently stirring with a magnetic stirrer.
Related substances: To pass the test.
Limits:
— any impurity: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
— total: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 per cent);
— disregard limit: area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Lead: Maximum 0.5 ppm.
Water: Maximum 0.5 per cent, determined on 1.00 g.
Microbial contamination:
If intended for use in the manufacture of parenteral preparations:
— TAMC: acceptance criterion 100 CFU/g.
If not intended for use in the manufacture of parenteral preparations:
— TAMC: acceptance criterion 1000 CFU/g;
— TYMC: acceptance criterion 100 CFU/g;
— absence of Escherichia coli;
— absence of Salmonella.
Bacterial endotoxins:
If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:
— less than 4 IU/g for parenteral preparations having a concentration of 100 g/L or less of erythritol;
— less than 2.5 IU/g for parenteral preparations having a concentration of more than 100 g/L of erythritol.

LABELLING
The label states where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.

IMPURITIES
A. 4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol),
B. D-glucitol (D-sorbitol),
C. (2R,3s,4S)-pentane-1,2,3,4,5-pentol (meso-ribitol),
D. propane-1,2,3-triol (glycerol).

Specifications of Erythritol USP NF Grade:
C4H10O4 --- 122.12
1,2,3,4-Butanetetrol
Butane 1,2,3,4-tetrol (meso-erythritol) --- CAS 149-32-6.

DEFINITION
Erythritol is obtained by fermentation of starch enzyme hydrolysate (from starches such as wheat and corn). It is obtained from the fermentation broth of suitable osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachiliensis. It contains NLT 96.0% and NMT 102.0% of erythritol (C4H10O4), calculated on the anhydrous basis.

IDENTIFICATION
A. Infrared Absorption.
B. Melting Range or Temperature: 119C –123C

Assay: Acceptance criteria: 96.0%–102.0% on the anhydrous basis
Residue on Ignition: NMT 0.1%
Limit of Lead: To pass the test Acceptance criteria:  NMT 0.5 micro-gm/g
Related Compounds:
Individual impurities:  NMT 2.0%
Total impurities:  NMT 2.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count using the Plate-Count Methods is NMT 1000 cfu/g, and the total combined molds and yeasts count is NMT 100 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on Drying: Dry the Sample at 105C for 4 h. Acceptance criteria:  NMT 0.2%.
Water Determination: NMT 0.5%
Conductivity: Acceptance criteria:  NMT 20 microS/cm
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.

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.