NY/T 1427-2016Guidelines for storage stability testing of pesticides at ambient temperature (English PDF)
农药常温贮存稳定性试验通则
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Issued by
Ministry of Agriculture of PRC
Level / Type
National · Recommended
Issue date
November 1, 2016
Implementation date
April 1, 2017
Scope
NY/T 1427-2016 is the English-translated version of 农药常温贮存稳定性试验通则.
NY/T 1427-2016 is the Chinese standard "Guidelines for storage stability testing of pesticides at ambient temperature". Its scope clause reads: This standard specifies the test methods for the storage stability of pesticides at ambient temperature and the requirements for the preparation of test reports.
This standard applies to the ambient temperature storage stability test for the registration of pesticide formulations. Its clauses include terms and definitions; test report preparation requirements.
It was issued by the Ministry of Agriculture of PRC on 2016-11-01 and took effect on 2017-04-01.
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Document preview — NY/T 1427-2016
National Standard of the People's Republic of China
- ICS
- 65.020
- Classification
- B 17
Issued by: Ministry of Agriculture of PRC
Contents
- Foreword...3
- 1 Scope...4
- 2 Terms and definitions...4
- 3 Test method...5
- 4 Test report preparation requirements...6
1 Scope
This standard specifies the test methods for the storage stability of pesticides at ambient temperature and the requirements for the preparation of test reports.
This standard applies to the ambient temperature storage stability test for the registration of pesticide formulations.
2 Terms and definitions
The terms and definitions apply to this document.
2.1
Shelf life
The period for ensuring the quality of pesticide products under specified storage conditions. During this period, the appearance of the product, the content of active ingredients, the content of related impurities, the content of other restricted components, other control items and the integrity of the product packaging meet the product technical specifications.
2.2
Relevant impurity
Compared with the effective ingredients of pesticides, the impurities of the pesticide products which are produced during the production or storage process and are obviously toxic to humans and the environment, or cause phytotoxicity to applicable crops, or cause agricultural product pollution, or affect the quality and stability of pesticide products, or cause other adverse effects.
2.3
Raw data
All original records and documents of the testing institution that recorded the original observations and investigation results in a test, or their verified
3.5 Testing items
The items to be tested include appearance, sample quality (including packaging) change rate, active ingredient content and isomer ratio, decomposition product content (when the effective ingredient decomposition rate is greater than 5%), related impurity content, contents of other restricted components (safener, stabilizer, etc.), other necessary control items (see appendix A) of the product and preparations (see Appendix A). If some solid preparations are packaged in soluble bags, appropriate indicators such as solubility and long-lasting foaming of the packaging shall be increased. It shall also be observed whether the packaging is deformed, leaked, or otherwise corroded.
3.6 Testing method
Adopt the relevant project testing methods of pesticide products as published by national standards, industry standards and the International Pesticide
Cooperative Analysis Committee (CIPAC), American Association of Analytical
Chemists (AOAC) and other international organizations, or confirmed self- developed methods.
4 Test report preparation requirements
The test report shall provide sufficient information, at least include the following:
a) Sample description. It shall include the name of the product, dosage form, batch number, packaging type (such as cylinder, can, aerosol can), packaging material (such as metal, plastic), net content (mass or volume), sample quantity.
b) Storage conditions.
1) Storage time: Storage start date.
2) Storage temperature: Monthly average temperature and maximum and minimum temperature.
3) Other storage conditions: Provide control conditions such as humidity and light when necessary.
c) Testing method. If the testing method adopted is the method of national standard, industry standard, enterprise standard or method recognized by relevant international organizations, it can be directly quoted and give the name and code of the standard or method. If other test methods are used, it shall give complete method and method validation process.
d) Test process. It shall give detailed description of the test process.
Appendix A (Normative)
Other control items that shall be determined in pesticide storage stability test at ambient temperature
A.1 Solid preparation
A.1.1 Powder DP
Other control items to be tested for powder include:
a) Acidity & alkalinity or pH;
b) Dry seive test.
A.1.2 Dispersible tablet WT
Other control items that shall be tested for dispersible tablets include:
a) Acidity & alkalinity or pH;
b) Disintegration time;
c) Suspension rate;
d) Wet sieve test;
e) Wear rate.
A.1.3 Granule GR
Other control items that shall be tested for granules include:
a) Acidity & alkalinity or pH;
b) Granularity range;
c) Dust;
d) Abrasion resistance (shedding rate or broken rate).
A.1.4 Soluble powder SP
Other control items that shall be tested for soluble powder include:
a) Acidity & alkalinity or pH;
A.1.9 Milk powder EP
Other control items that shall be tested for milk powder include:
a) Acidity & alkalinity or pH;
b) Wetting time;
c) Wet sieve test;
d) Dispersion stability.
A.1.10 Emulsion EG
Other control items that shall be tested for emulsions include:
a) Acidity & alkalinity or pH;
b) Wetting time;
c) Dispersion stability;
d) Wet sieve test;
e) Dust;
f) Wear resistance.
A.1.11 Water dispersible granules WG
Other control items that shall be tested for water dispersible granules include:
a) Acidity & alkalinity or pH;
b) Suspension rate;
c) Wet sieve test;
d) Dispersibility;
e) Dust;
f) Wear resistance.
A.2 Liquid preparation
A .2.1 Ultra-low volume liquid UL
Other control items that shall be measured for ultra-low volume liquids include:
Acidity & alkalinity or pH.
b) Emulsion stability.
A.2.8 Microcapsule suspension agent CS
Other control items that shall be tested for microcapsule suspension agents include:
a) Contents of free active ingredients;
b) Acidity & alkalinity or pH;
c) Wet sieve test;
d) Suspension rate;
e) Spontaneous dispersion;
f) Dumping.
A.2.9 Microcapsule suspension - water emulsion ZW
Other control items that shall be tested for microcapsule suspension - water emulsion include:
a) Contents of free active ingredient;
b) Acidity & alkalinity or pH;
c) Wet sieve test;
d) Dispersion stability;
e) Dumping.
A.2.10 Microcapsule suspension - suspension agent ZC
Other control items that shall be tested for microcapsule suspension- suspension include:
a) Free active ingredient content;
b) Acidity & alkalinity or pH;
c) Wet sieve test;
d) Suspension rate;
e) Spontaneous dispersion;
f) Dumping.
a) Acidity & alkalinity or pH;
b) Miscibility with hydrocarbon oils.
A.3 Seed treatment preparation
A.3.1 Suspended seed coating agent FSC
Other control items that shall be tested for suspension seed coating agents include:
a) Acidity & alkalinity or pH;
b) Wet sieve test;
c) Suspension rate.
A.3.2 Seed treatment dry powder DS
Other control items that shall be tested for dry seed treatment powder include:
a) Acidity & alkalinity or pH;
b) Dry sieve test;
c) Adhesion.
A.3.3 Seed treatment dispersible powder WS
Other control items that shall be tested for seed treatment dispersible powders include:
a) Acidity & alkalinity or pH;
b) Wet sieve test;
c) Adhesion.
A.3.4 Seed treatment emulsion ES
Other control items that shall be tested for seed treatment emulsion include:
a) Acidity & alkalinity or pH;
b) Emulsion stability;
c) Adhesion.
A.3.5 Seed treatment suspension agent FS
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 6 pages — is available in the English PDF.
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