GB/T 22114-2021 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 22114-2021 | English | 175 |
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Humectants for toothpastes - Glycerin and polyethylene glycol
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| GB 22114-2008 | English | 140 |
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Humectants for toothpastes -- Glycerin and macrogol
| Obsolete |
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GB/T 22114-2021: Humectants for toothpastes - Glycerin and polyethylene glycol---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT22114-2021
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
ICS 71.100.40
CCS Y 43
Replacing GB 22114-2008
Humectants for toothpastes - Glycerin and polyethylene
glycol
Issued on: MAY 21, 2021
Implemented on: DECEMBER 1, 2021
Issued by. State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Requirements... 6
5 Test methods... 7
6 Inspection rules... 12
7 Packaging, marking, transportation, storage and shelf life... 13
Humectants for toothpastes - Glycerin and polyethylene
glycol
1 Scope
This document specifies the requirements, test methods, inspection rules, packaging,
labeling, transportation, storage, shelf life, etc. of glycerin (glycerol) and polyethylene
glycol used as humectants for toothpaste.
This document applies to glycerin and polyethylene glycol with a relative molecular
mass of 200~8000, which are used as humectants for toothpaste.
2 Normative references
The provisions of the following documents constitute the essential clauses of this
document through normative references in this text. Among them, for referenced
documents with dates, only the versions corresponding to the dates are applicable to
this document; for referenced documents without dates, the latest versions (including
all amendments) are applicable to this document.
GB/T191 Packaging - Pictorial marking for handling of goods
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 6678 General principles for sampling chemical products
GB/T 6679 General rules for sampling solid chemical products
GB/T 6680 General rules for sampling liquid chemical products
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 13216 Test methods for glycerin
GB/T 35919 Oral cavity nursing materials classifications and terms
JJF 1070 Rules of Metrological Testing for Net Quantity of Products in
Unless otherwise specified, the standard solutions used in titration analysis, standard
solutions used in impurity determination, preparations and products used in the test
methods in this document shall be prepared in accordance with the provisions of GB/T
601, GB/T 602 and GB/T 603.
5.2 Test method for glycerin for toothpastes
5.2.1 Appearance
The test shall be carried out according to the provisions of GB/T 13216.
5.2.2 Odor
The test shall be carried out according to the provisions of GB/T 13216.
5.2.3 Color
The test shall be carried out according to the provisions of GB/T 13216.
5.2.4 Glycerin content
In the case of the simplified method, the test is carried out according to the density
method (determination of glycerin content) in GB/T 13216; in the case of arbitration,
the test is carried out according to the titration method (determination of glycerin
content) in GB/T 13216.
5.2.5 Density
The test shall be carried out according to the provisions of GB/T 13216.
5.2.6 Chloride
The test shall be carried out according to the provisions of GB/T 13216.
5.2.7 Sulfated ash
The test shall be carried out according to the provisions of GB/T 13216.
5.2.8 Acidity or alkalinity
The test shall be carried out according to the provisions of GB/T 13216.
5.2.9 Saponification equivalent
The test shall be carried out according to the provisions of GB/T 13216.
5.2.10 Iron salts
The test is carried out according to method 0807 in the general rules of the
Pharmacopoeia of the People's Republic of China 2015 edition (Volume IV).
5.2.11 Diethylene glycol and related compounds
5.2.11.1 Instruments
Gas chromatograph. it is equipped with a flame ionization detector; the
chromatographic column is G43 [6% cyanopropyl phenyl - 94% p-methylpolysiloxane
(mass fraction)] (0.53 mm×30 m×3 μm) elastic quartz capillary column, and the
injection port liner type is an inward-rolled cup.
The chromatographic program is set as follows. the initial temperature of the
chromatographic column is 100 °C. After injection, the temperature is increased to
220 °C at a rate of 7.5 °C/min and maintained for 4 min. The temperature of the injection
port is maintained at 220 °C, and the temperature of the detector is maintained at 250 °C.
The carrier gas is helium. The split ratio is 10.1, and the column flow rate is 5 mL/min.
After the resolution liquid is injected, the chromatographic peak response is recorded
according to the conditions specified in the determination method. The separation
degree of the two peaks of diethylene glycol and glycerin in the chromatogram shall
not be less than 7.0.Repeat the injection of the standard solution and record the
chromatographic peak area. The relative standard deviation shall not exceed 15%.
5.2.11.2 Reagents
5.2.11.2.1 Glycerin and diethylene glycol. chromatographic grade
5.2.11.2.2 Resolution liquid
Accurately weigh chromatographically pure diethylene glycol and glycerin, dissolve
them in water, dilute quantitatively, and dilute them stepwise with water when
necessary to make solutions with a diethylene glycol and glycerin concentration of
approximately 0.5 mg/mL.
5.2.11.2.3 Standard solution
Accurately weigh diethylene glycol, dissolve it in water, dilute it quantitatively, and
dilute it step by step if necessary to make a solution with a diethylene glycol
concentration of about 0.05 mg/mL.
5.2.11.2.4 Test solution
Accurately weigh 5.00 g of glycerin into a 100 mL volumetric flask, dissolve it in water
and dilute to the mark, then shake well.
5.2.11.3 Test steps
According to the pharmaceutical excipients in the Pharmacopoeia of the People's
Republic of China 2015 edition (Volume IV) and the corresponding labeled molecular
weight of polyethylene glycol, the test shall be carried out according to the
corresponding method for "ethylene oxide and dioxane" in the document.
5.3.7 Formaldehyde
According to the pharmaceutical excipients in the Pharmacopoeia of the People's
Republic of China 2015 edition (Volume IV) and the corresponding labeled molecular
weight of polyethylene glycol, the test shall be carried out according to the
corresponding method for "formaldehyde" in the document.
5.3.8 Heavy metals
The test is carried out in accordance with the provisions of the first method of 0821 in
the general rules of the Pharmacopoeia of the People's Republic of China 2015 edition
(Volume IV).
5.3.9 Arsenic
The test is carried out in accordance with the provisions of the first method of 0822 in
the general rules of the Pharmacopoeia of the People's Republic of China 2015 edition
(Volume IV).
5.4 Net content
The net content of packaged humectants used for toothpaste shall be in accordance with
the provisions of JJF 1070.
6 Inspection rules
6.1 Classification of inspection
6.1.1 Factory inspection
The factory inspection items for glycerin include sensory indexes, physicochemical
indexes, and requirements for diethylene glycol and related compounds.
The factory inspection items for polyethylene glycol include sensory indexes,
physicochemical indexes, and requirements for toxic substance limit indexes.
6.1.2 Type inspection
All items specified in the technical requirements of this document are type inspection
items. Under normal circumstances, a type inspection is carried out every three months.
Type inspection shall be carried out in the following cases.
a) When key production processes are updated;
b) When there are changes in the main raw materials;
c) When production is resumed after suspension;
d) When the national quality supervision agency or the purchaser requests a type
inspection.
6.1.3 Acceptance inspection
The purchaser has the right to inspect and accept the products received in accordance
with the relevant terms of the contract signed by the supply and demand parties and the
provisions of this document. The inspection and acceptance shall be completed within
15 days from the date of arrival of the goods.
6.2 Batching and sampling rules
6.2.1 Products of the same specifications delivered at one time are considered as one
batch.
6.2.2 Products must first be inspected and certified by the quality inspection department
of the manufacturer in accordance with the provisions of this document, and can only
be shipped out after an inspection report is issued. The receiving unit shall accept and
inspect in accordance with this document.
6.2.3 The sampling of glycerin and polyethylene glycol shall be carried out in
accordance with GB/T 6678, GB/T 6679 and GB/T 6680, and the sampling volume
shall not be less than 500 g.
6.3 Judgment rules
If the test results do not meet the standard requirements, re-sampling and re-testing shall
be carried out. If the re-testing results still do not meet the requirements, the entire batch
of products will be treated as unqualified products.
6.4 Sample storage and sample retention
Samples must be retained for each batch of accepted products and the samples shall be
retained for 30 days.
7 Packaging, marking, transportation, storage and shelf life
7.1 Packaging
This product is a raw material for high-cleanliness oral hygiene and care products. The
...... Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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