(e rith' ri tol).
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.
• B. Melting Range or Temperature 741: 119123
Mobile phase: 0.01% sulfuric acid
System suitability solution: 0.05 mg/mL each of USP Erythritol RS and glycerol
Standard solution: 50 mg/mL of USP Erythritol RS
Sample solution: 50 mg/mL of Erythritol
Detector: Refractive index
Column: 7.8-mm × 30-cm; packing L17
Column temperature: 70
Flow rate: 0.8 mL/min
Injection size: 10 µL
Samples: System suitability solution and Standard solution
[NoteThe relative retention times for erythritol and glycerol are about 1.0 and 1.1, respectively. ]
Resolution: NLT 2.0 between erythritol and glycerol, System suitability solution
Relative standard deviation: NMT 2.0%, Standard solution
Samples: Standard solution and Sample solution
[NoteRecord chromatograms for over a period of three times the retention time of erythritol. ]
Calculate in percentage of erythritol (C4H10O4) in the portion of Erythritol taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 96.0%102.0% on the anhydrous basis
• Residue on Ignition 281: NMT 0.1%
• Limit of Lead
Standard lead solution: Prepare as directed under Heavy Metals 231, Special Reagents.
Sample solution: Dissolve 20.0 g of Erythritol in diluted acetic acid, and dilute with the same medium to 100 mL. Add 2.0 mL of a saturated ammonium pyrrolidinedithiocarbamate solution (10 mg/mL of ammonium pyrrolidinedithiocarbamate) and 10.0 mL of methyl isobutyl ketone, and shake for 30 s. Protect from bright light. Allow the two layers to separate, and use the methyl isobutyl ketone layer.
Standard solutions: Prepare as directed for the Sample solution, except prepare three solutions by adding 0.5, 1.0, and 1.5 mL of Standard lead solution in addition to the 20.0 g of Erythritol.
Blank solution: Prepare as directed for the Sample solution, omitting Erythritol.
Mode: Atomic absorption spectrophotometry, using methyl isobutyl ketone previously treated as described under Sample solution, but without the sample added
Analytical wavelength: 283.3 nm
Lamp: Lead hollow-cathode
Samples: Sample solution and Standard solutions
Introduce the Sample solution and each of the three Standard solutions into the instrument. Record the steady absorbance reading. Plot the absorbance readings against the known concentrations of added lead (in µg), and draw a straight line. Extrapolate the line until it meets the concentration axis, which is equal to the concentration, in ppm, of lead in the sample.
Acceptance criteria: NMT 0.5 ppm
• Related Compounds
Mobile phase, System suitability solution, Standard solution, and Sample solution: Proceed as directed in the Assay.
Standard solution: Transfer 2.0 mL of the Standard solution from the Assay to a 100-mL volumetric flask, and dilute with water (1 mg/mL of erythritol).
Chromatographic system: Proceed as directed in the Assay, except use an Injection size of 20 µL.
Samples: Sample solution and Standard solution
Calculate the percentage of each impurity found:
Result = (rU/rS) × (CS/CU) × 100
Individual impurities: NMT 2.0%
Total impurities: NMT 2.0%
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count using the Plate Method 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 731: Dry an 8-g sample at 105 for 4 h: it loses NMT 0.2% of its weight.
• Water Determination, Method I 921: NMT 0.5%
Sample solution: 200 mg/mL in water
Analysis: Using an appropriate conductivity meter, choose a conductivity cell that is appropriate for the properties and conductivity of the solution to be examined. Use a certified reference material,1 for example, a solution of potassium chloride, that is appropriate for the measurement. The conductivity value of the certified reference material should be near the expected conductivity value of the solution to be examined. After calibrating the apparatus with a certified reference material solution, rinse the conductivity cell several times with water and at least twice with the aqueous solution to be examined. Measure the conductivity of the solution at a temperature of 20 while stirring gently with a magnetic stirrer.
Acceptance criteria: NMT 20 µS/cm
• Packaging and Storage: Preserve in well-closed containers. Store at room temperature.
• USP Reference Standards 11
1 Commercially available conductivity calibration solutions for conductivity meter standardization, standardized by methods traceable to the National Institute of Standards and Technology (NIST), may be used. Solutions prepared according to instructions given in the American Society for Testing and Materials (ASTM) Standard D1125 may be used, provided that the conductivity of the resultant solution is the same as that of the solution prepared from the NIST-certified material.
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USP35NF30 Page 1791Pharmacopeial Forum: Volume No. 31(5) Page 1422