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GB 22114-2008: Humectants for toothpastes -- Glycerin and macrogol
GB 22114-2008
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 71.100.40
Y 43
Humectants for toothpastes - Glycerin and macrogol
ISSUED ON: JUNE 27, 2008
IMPLEMENTED ON: JUNE 01, 2009
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of the PRC;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Requirements ... 5 
4 Test methods ... 7 
5 Inspection rules ... 14 
6 Packaging, marking, transportation, storage ... 16 
Humectants for toothpastes - Glycerin and macrogol
1 Scope
This Standard specifies the requirements, test methods, inspection rules,
packaging, marking, transportation, and storage of glycerin and macrogol in
humectants for toothpastes.
This Standard applies to glycerin and macrogol as humectants for toothpastes.
2 Normative references
The following documents contain the provisions which, through reference in this
Standard, become the provisions of this Standard. For the dated references,
their subsequent amendments (excluding corrections) or revisions do not apply
to this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest editions of these
documents are applicable. For undated reference documents, the latest
editions apply to this Standard.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods (GB/T 191-
2008, ISO 780:1997, MOD)
GB/T 601 Chemical reagent - Preparations of reference titration solutions
GB/T 602 Chemical reagent - Preparations of standard solutions for impurity
GB/T 603 Chemical reagent - Preparations of reagent solutions for use in
test methods
GB/T 6682 Water for analytical laboratory use - Specification and test
methods
GB/T 6678 General Principles for Sampling Chemical Products
GB/T 13216.2-1991 Test methods for glycerines - Determination of
transparency
GB/T 13216.3-1991 Test methods for glycerines - Determination of odour
GB/T 13216.4-1991 Test methods for glycerines - Determination of color
(Hazen unit - Platinum-Cobalt scale)
The net quantity of the toothpaste humectant packaged products shall comply
with the provisions of JJF 1070-2005.
4 Test methods
The reagents and water used in this Standard, unless otherwise specified, are
analytically pure reagents and water in accordance with GB/T 6682.
In the Standard, reference solutions for titration analysis, standard solutions for
impurity, and reagent solutions for use in test methods, unless otherwise
specified, shall be prepared in accordance with the provisions of GB/T 601,
GB/T 602, and GB/T 603.
4.1 Test method for glycerin for toothpaste
4.1.1 Appearance
It shall be carried out according to the provisions of GB/T 13216.2.
4.1.2 Odor
It shall be carried out according to the provisions of GB/T 13216.3.
4.1.3 Color
It shall be carried out according to the provisions of GB/T 13216.4.
4.1.4 Glycerol content
It shall be carried out according to the provisions of GB/T 13216.6.
4.1.5 Density
It shall be carried out according to the provisions of GB/T 13216.5.
4.1.6 Chloride
It shall be carried out according to the provisions of GB/T 13216.7.
4.1.7 Sulphated ash
It shall be carried out according to the provisions of GB/T 13216.8.
4.1.8 Acidity or alkalinity
It shall be carried out according to the provisions of GB/T 13216.9.
4.1.9 Reducing substances
d) Test solution: Accurately WEIGH about 5 g of glycerin into a 100 mL
volumetric flask; USE water to dissolve and dilute to mark; shake well.
4.1.12.3 Test procedure
The same volume (about 0.5 μL) of the standard solution and the test solution
are injected separately. The chromatogram is recorded. All the peak areas are
measured. According to formula (1), calculate the diethylene glycol content (C1)
in the glycerin sample:
Where:
C1 - Diethylene glycol content, %;
cS - The concentration of diethylene glycol in the standard solution, in milligrams
per milliliter (mg/mL);
cU - The concentration of glycerin sample in the test solution, in milligrams per
milliliter (mg/mL);
ru - The peak area of diethylene glycol in the chromatogram of the test solution;
rs - The peak area of diethylene glycol in the chromatogram of the standard
solution.
According to formula (2), calculate the content (C2) of other impurities
(excluding solvent peaks) in the glycerin sample:
Where:
C2 - The content of other impurities (excluding solvent peaks) in the glycerin
sample, %;
ri - The peak area of each impurity obtained from the solution to be tested;
rs - The sum of all peak areas obtained from the test solution.
4.1.13 Arsenic
It shall be carried out according to the provisions of the silver
diethyldithiocarbamate method in Appendix VIII J of the Pharmacopoeia of the
PRC (2005 Edition) (Part 2).
solution to neutralize the pyridine therein for a blank determination. The volume
of 0.5 mol/L sodium hydroxide consumed is recorded and recorded as B.
4.2.2.4 Calculation of average molecular weight
According to formula (3), calculate the average molecular weight (M) of
macrogol in the sample:
Where:
M - The average molecular weight of macrogol;
m - The mass of macrogol used for preparing the test solution, in grams (g);
B - The amount of 0.5 mol/L sodium hydroxide consumed by the blank, in
milliliters (mL);
S - The amount of 0.5 mol/L sodium hydroxide consumed by the sample, in
milliliters (mL);
c - The concentration of sodium hydroxide solution, in moles per liter (mol/L).
4.2.3 pH
It shall be carried out according to the provisions of Appendix VI H of the
Pharmacopoeia of the PRC (2005 Edition) (Part 2).
4.2.4 Diethylene glycol and ethylene glycol
4.2.4.1 Determination of diethylene glycol and ethylene glycol content in
macrogol sample with an average molecular weight of less than 450
4.2.4.1.1 Main instrument
Gas chromatography: Equipped with a flame ionization detector. The stainless-
steel 3 mm×1.5 m chromatographic column is filled with untreated diatomite
carrying 12% sorbitol. The carrier gas is nitrogen or other suitable inert gas. The
flow rate is 50 mL/min. The column temperature is maintained at 140 °C. The
temperature at the injection port is maintained at 250 °C. The flame ionization
detector’s temperature is maintained at 280 °C.
4.2.4.1.2 Reagents
a) Diethylene glycol and ethylene glycol: Chromatographically pure;
Where:
C4 - The content of diethylene glycol, %;
c2 - The concentration of diethylene glycol in the standard solution, in
micrograms per milliliter (μg/mL);
p2 - The peak height of diethylene glycol for the test solution, in millimeters (mm);
P2 - The peak height of diethylene glycol for the standard solution, in millimeters
(mm);
m - The mass of diethylene glycol used in the test, in milligrams (mg).
4.2.4.2 Determination of diethylene glycol and ethylene glycol content in
macrogol sample with an average molecular weight higher than 450 and
less than 1000
4.2.4.2.1 Main instruments
a) Distilling flask;
b) Spectrophotometer.
4.2.4.2.2 Reagents
a) Nitric acid: 0.25 mol/L;
b) Ammonium ceric nitrate: 6.25 g of ammonium ceric nitrate is dissolved in
100 mL of 0.25 mol/L nitric acid solution, used within 3 d after preparation;
c) Standard solution: 62.5 mg of diethylene glycol is placed in a 25 mL
volumetric fla...