Synonyms: Xylitol

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XYLITOL

Prepared at the 46th JECFA (1996), published in FNP 52 Add 4 (1996)


superseding specifications prepared at the 33rd JECFA (1988), published in
FNP 38 (1988). Metals and arsenic specifications revised at the 57th
JECFA (2001). An ADI 'not specified' was established at the 27th JECFA
(1983)

SYNONYMS

INS No. 967

DEFINITION
Chemical names

Xylitol

C.A.S. number

87-99-0

Chemical formula

C5H12O5

Structural formula

Formula weight

152.15

Assay

Not less than 98.5% and not more than 101.0% on the anhydrous basis

DESCRIPTION

White, crystalline powder, practically odourless

FUNCTIONAL USES Sweetener, humectant


CHARACTERISTICS
IDENTIFICATION
Solubility (Vol. 4)

Very soluble in water, sparingly soluble in ethanol

Melting range (Vol. 4)

92 - 96o

Infrared absorption

The infrared spectrum of a potassium bromide dispersion of the sample


corresponds with the reference infrared spectrum below

PURITY
Water (Vol. 4)

Not more than 0.5% (Karl Fischer Method)

Sulfated ash (Vol. 4)

Not more than 0.1%


Test 2 g of sample (Method I)

Nickel (Vol. 4)

Not more than 2 mg/kg


Proceed as directed under Nickel in Polyols

Reducing sugars (Vol. 4) Not more than 0.2%

Dissolve about 500 mg of the sample, accurately weighed, in 2 ml of water


in a 10 ml conical flask. To a second conical flask add 2 ml of a dextrose
solution containing 0.5 mg per ml. Add 2 ml of cupric tartrate, alkaline TS to
each flask, heat to boiling, and cool. The sample solution is less turbid than
the dextrose solution, in which a reddish brown precipitate is formed.
Other polyols

Not more than 1.0%


Proceed as described under Method of Assay and calculate the percentage
of each polyol (L-arabinitol, galactitol, mannitol, and sorbitol) by the formula
therein given, in which WS refers to the weight, in mg, of the respective
polyol taken for the standards solution; RS is the peak response ratio of the
corresponding polyol obtained from the Standard solution; and RU is the
peak response ratio of the corresponding polyol obtained from the Sample
preparation. Sum the four individual polyol percentages to obtain the total.

Lead (Vol. 4)

Not more than 1 mg/kg


Determine using an atomic absorption technique appropriate to the
specified level. The selection of sample size and method of sample
preparation may be based on the principles of the method described in
Volume 4, Instrumental Methods.

METHOD OF
ASSAY

Internal standard solution:


Transfer about 500 mg of erythritol, accurately weighed, into a 25 ml
volumetric flask, dilute to volume with water, and mix.
Standard solution:
Transfer about 25 mg each of L-arabinitol, galactitol, mannitol, and sorbitol,
accurately weighed, to a 100-ml volumetric flask, dilute to volume with
water, and mix. To an accurately measured volume of this solution, add an
accurately weighed amount of Reference Standard Xylitol (available from
US Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville,
MD 20852, USA) to obtain a solution with a known concentration of about
49 mg/ml.
Sample preparation:
Transfer about 5 g of the sample, accurately weighed, into a 100-ml
volumetric flask, dilute to volume with water, and mix.
Chromatography
Use a gas chromatograph equipped with a flame-ionization detector and a
2-m x 2-mm glass column packed with 3% liquid phase of 25% phenyl-25%
cyanopropylmethylsilicone (OV-225 or equivalent) on silanized siliceous
earth support (Chromosorb W-HP or equivalent). The carrier gas is nitrogen
flowing at about 30 ml/min. The injector port temperature is 250o, the
column temperature 200o and the detector temperature 250o.
Chromatograph the derivatized Standards Solution prepared as directed
under Procedure, and record the peak responses. The relative retention
times corresponding to erythritol, L-arabinitol, xylitol, galactitol, mannitol,
and sorbitol are usually about 1.0, 2.77, 3.90, 6.96, 7.63 and 8.43,

respectively. The relative standard deviation of the response ratios of the


derivatized Xylitol to the derivatized erythritol from three replicate injections
does not exceed 2.0%.
Procedure:
Pipet 1 ml portions of the standards solution and the sample preparation
into separate 100-ml, round-bottom boiling flasks. To each flask, add 1.0 ml
of internal standard solution, and evaporate the respective mixtures to
dryness on a water bath at 60o with the aid of a rotary evaporator. Dissolve
each dry residue in 1 ml of pyridine, and add 1 ml of acetic anhydride to
each flask. Boil each solution under reflux for 1 h to complete the
acetylation. Separately inject 1-l portions of the derivatized solutions from
the sample preparation and the standard solution into the gas
chromatograph and measure the peak responses. Calculate the percentage
of xylitol, on the as-is basis, by the formula:

where
WS = the weight, in mg, of Reference Standard Xylitol used for the Standard
solution
WU = the weight, in mg, of the sample taken for the Assay preparation
RU and RS = the ratios of peak responses of the derivatized analyte to the
derivatized erythritol from the Internal Standard solution obtained from the
Sample Preparation and the Standard Solution, respectively. Using the
value obtained in the water determination, correct the percentage to the
anhydrous basis.

Infrared spectrum

Xylitol

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