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GB/T 22114-2021 PDF English

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GB/T 22114-2021: Humectants for toothpastes - Glycerin and polyethylene glycol
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GB/T 22114: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
GB/T 22114-2021English175 Add to Cart 0-9 seconds. Auto-delivery Humectants for toothpastes - Glycerin and polyethylene glycol Valid
GB 22114-2008English140 Add to Cart 0-9 seconds. Auto-delivery Humectants for toothpastes -- Glycerin and macrogol Obsolete

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GB/T 21241   GB 22115   GB/T 35832   

GB/T 22114-2021: Humectants for toothpastes - Glycerin and polyethylene glycol

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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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