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GB 29385-2012: [GB/T 29385-2012] Pyrimethanil technical material
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[GB/T 29385-2012] Pyrimethanil technical material
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Basic data
Standard ID: GB 29385-2012 (GB29385-2012)
Description (Translated English): [GB/T 29385-2012] Pyrimethanil technical material
Sector / Industry: National Standard
Classification of Chinese Standard: G25
Classification of International Standard: 65.100.30
Word Count Estimation: 12,168
Quoted Standard: GB/T 1600; GB/T 1601; GB/T 1604; GB/T 1605-2001; GB 3796; GB/T 6682-2008; GB/T 8170-2008; GB/T 19138
Regulation (derived from): National Standards Bulletin No. 42 of 2012
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This Chinese standard specifies pyrimethanil original drug requirements, test methods and marking, labeling, packaging, storage, inspection period. This standard applies to pyrimethanil and its impurities generated in the production of pyrimethanil origin
GB 29385-2012: [GB/T 29385-2012] Pyrimethanil technical material
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Pyrimethanil technical material
ICS 65.100.30
G25
National Standards of People's Republic of China
Pyrimethanil original drug
Published 2012-12-31
2013-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Foreword
This standard in Chapter 3, Section 5 is mandatory, the rest are recommended.
This standard was drafted in accordance with rules GB/T 1.1-2009 given.
Please note that some of the content of this document may involve patents, the issuing authority of this document does not assume responsibility for identifying these patents.
The standard proposed by China Petroleum and Chemical Industry Federation.
This standard by the National Pesticide Standardization Technical Committee (SAC/TC133).
This standard is drafted. Shenyang Chemical Research Institute Co., Ltd.
Participated in the drafting of this standard. Limin Chemical Co., Ltd., Jiangsu Feng Deng Pesticide Co., Jiangsu Qantas Agrochemical Company Limited
Secretary, Jiangsu hard Chemical Co., Ltd.
The main drafters of this standard. High Scenic, Wang Haixia, Zhang Ruifang, Geng Rongwei, Shen Jian, Liu Mulan, Chen Jie.
Pyrimethanil original drug
1 Scope
This standard specifies the requirements pyrimethanil original drug, Test Method for marking, labeling, packaging, storage, and acceptance period.
This standard applies to impurities derived from the production of pyrimethanil and composition pyrimethanil original drug.
Note. Other names, structural formulas and physicochemical parameters of the basic pyrimethanil see Appendix A.
2 Normative references
The following documents for the application of this document is essential. For dated references, only applies to the version dated paper
Pieces. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1600 Pesticide Method Moisture
Determination 1601 pH value pesticides GB/T
GB/T 1604 pesticide regulations for acceptance of goods
GB/T 1605-2001 sampling commercial pesticides
GB 3796 pesticide packaging General
GB/T 6682-2008 analytical laboratory use specifications and test methods (ISO 3696. 1987, MOD)
GB/T 8170-2008 rounding off means about rules and determining limiting values
GB/T 19138 Determination of acetone insoluble pesticide
3.1 Appearance
White powder solid, without visible foreign matter and added modifier.
3.2 Technical Specifications
Pyrimethanil original drug should also meet the requirements of Table 1.
Table 1 pyrimethanil original drug control project indicators
Item Index
Pyrimethanil mass fraction /% ≥ 97.0
Acetone insolubles a /% ≤ 0.2
Moisture /% ≤ 0.5
pH range 6.0 to 10.0
When a normal production, the acetone insoluble matter measured at least once every three months.
Test Method 4
Safety Tips. to use this standard shall have practical experience of laboratory work. This standard does not indicate any safety issues. Make
With those who have the responsibility to take appropriate safety and health practices and to ensure compliance with the provisions of relevant state laws and regulations.
4.1 General provisions
This standard reagent in the absence of water and other requirements stated, refer to three predetermined analytical reagents and GB/T 6682-2008 of
water. The test results performed by determining 4.3.3 rounding value in comparison 8170-2008 GB/T .
4.2 Sampling
Carried out in GB/T 1605-2001 of "original drug product sampling" approach. Determined by sampling a random number table method packages, the amount of the final sample
Not less than 100g.
4.3 Identification Test
Infrared spectroscopy --- Sample Sample pyrimethanil IR in the range of 4000cm-1 ~ 400cm-1 absorption spectrum should be no significant
difference. Pyrimethanil standard infrared spectra of Figure 1.
HPLC --- This identification test can be carried out simultaneously with the determination of the mass fraction of pyrimethanil. In the same chromatographic operating conditions
, The peak of a retention time in the sample solution and the standard solution of amine Pyrimethanil retention time, the relative difference should be less than 1.5%.
cm-1
1 pyrimethanil standard infrared spectrum of FIG.
Determination of the mass fraction of 4.4 pyrimethanil
4.4.1 Method summary
Sample dissolved in mobile phase, methanol water, phosphoric acid as the mobile phase, used as a filler C18 stainless steel column and UV detector
(300 nm), the sample pyrimethanil reverse phase high performance liquid chromatography, external standard. It may also be determined using gas chromatography, color
Spectrum operating conditions, see Appendix B.
4.4.2 Reagents and solutions
Methanol. HPLC grade;
Water. The new secondary steam distilled water;
Phosphoric acid;
Pyrimethanil Sample. pyrimethanil known mass fraction, w≥98.0%.
4.4.3 Instruments
HPLC. a variable wavelength UV detector;
Chromatographic data processor or workstation;
Column. 250mm × 4.6mm (id) stainless steel column, the contents C18,5μm filler;
Filter. membrane pore size of about 0.45 m;
Microsyringe. 50μL;
Quantitative sampling tube. 5μL;
Ultrasonic cleaning.
4.4.4 HPLC operating conditions
Mobile phase. [Psi] [methanol. water (adjusted with phosphoric acid pH = 3)] = 75.25, filtered through a filter, and degassed;
Flow rate. 1.0mL/min;
Column temperature. room temperature;
Detection wavelength. 300nm;
Injection Volume. 5μL;
Retention time. pyrimethanil about 5.5min.
Are typical operating parameters of the above, according to the characteristics of different instruments, for a given operating parameters appropriately adjusted to obtain the best result.
Typical pyrimethanil original drug by HPLC is shown in Figure 2.
1 --- pyrimethanil.
Figure 2 HPLC original drug pyrimethanil
4.4.5 Determination Step
4.4.5.1 Preparation of standard solution
Weigh 0.1 g of pyrimethanil standard (accurate to 0.0001g), was placed in a 50mL volumetric flask, add the mobile phase is shaken to dissolve, with the flow
Phase was diluted to the mark. With the above-described pipette 5mL sample solution flows to the other phase in dilute 50mL volumetric flask,
Shake well.
4.4.5.2 Preparation of sample solution
Weigh 0.1g pyrimethanil containing sample (nearest 0.0001g), was placed in a 50mL volumetric flask, add the mobile phase is shaken to dissolve, with
Mobile phase and dilute to the mark. With the above-described pipette 5mL sample solution flows to the other phase in dilute 50mL volumetric flask,
Shake well.
4.4.5.3 Determination
Under the above operating conditions, after the instrument is stable, the number of consecutive doses of the standard solution is injected until the two needles pyrimethanil relative change in peak area adjacent
After less than 1.2%, measured according to the standard solution, sample solution, the sample solution, the order of standard solution.
4.4.5.4 computing
The two needle and the sample solution was measured before and after the two doses of the standard sample solution Pyrimethanil average peak area, respectively. Pyrimethanil sample
The mass fraction, calculated according to formula (1).
w1 = A2
· M1 · w
A1 · m2
(1)
Where.
W1 --- pyrimethanil sample mass fraction in%;
A2 --- sample solution, pyrimethanil average peak area amine;
M1 --- Sample mass in grams (G);
W --- Sample pyrimethanil amine content, expressed in%;
A1 --- the standard solution, pyrimethanil average peak area amine;
--- M2 sample mass, in grams (g).
4.4.5.5 allow poor
Results difference pyrimethanil replicates should be less than twice the mass fraction of 1.2%, and the arithmetic mean value as a measurement result.
4.5 Determination of acetone insolubles
According to GB/T 19138 carried out.
4.6 Determination of Moisture
According to GB/T 1600 in a "Karl Fischer method."
4.7 pH value measured
Carried out in GB/T 1601.
4.8 product testing and acceptance
Shall comply with the provisions of GB/T 1604's.
5 marking, labeling, packaging, storage, security, acceptance period
5.1 marking, labeling, packaging
Flag pyrimethanil original drug, labeling and packaging should comply with the provisions of GB 3796.
Pyrimethanil original drug packaging is lined with plastic bags or cardboard drum barrel (bag) weight 25kg. Also available upon request
Agreement or order other forms of packaging, subject to the provisions of GB 3796.
5.2 Storage
Pyrimethanil original drug package airiness, drying, low temperature warehouses. Storage and transportation, to prevent moisture and sunlight, no food, seed
Promoter, feed-mixing, avoid contact with the skin, eyes, mouth and nose to prevent inhalation.
5.3 Security
Pyrimethanil fungicide is low toxicity, ingestion and inhalation are toxic, irritating to the eyes, the FDA should wear protective equipment, after application should
Wash with soap, once swallowed, should be immediately sent to hospital for symptomatic treatment.
5.4 Acceptance of
Pyrimethanil original drug acceptance period of one month. The quality of the finished product acceptance within one month from the date of delivery, the indicators should be consistent with standard
Prospective requirements.
Appendix A
(Informative)
Other names pyrimethanil, and basic physicochemical parameters of the formula
Other names, structural formulas and physicochemical parameters of the product basic active ingredient pyrimethanil as follows.
ISO common name. pyrimethanil
CAS Registry Number. 53112-28-0
CIPAC Numeric Code. 714
Chemical name. N- (4,6- dimethyl-pyrimidin-2-yl) aniline
Structure.
Empirical formula. C12H13N3
Molecular weight.199.25
Biological activity. bactericidal
Melting point. 96.3 ℃
Vapor pressure (25 ℃). 2.2 × 10-3Pa
Solubility (20 ℃, g/L). 0.121 water (pH = 6.1,25 ℃), acetone 389, 617 in ethyl acetate, dichloromethane
1000, 23.7 n-hexane, toluene, 412, 176 methanol
Stability. The stability in water and pH dependent, stable storage 54 ℃ 14d.
Appendix B
(Informative)
Pyrimethanil mass fraction of gas chromatographic method
B.1 Method summary
Samples with chloroform (or dimethylformamide) was dissolved, di-n-butyl phthalate as an internal standard, using HP-5 as filler
Capillary column and flame ionization detector, a sample of pyrimethanil and measured by gas chromatography internal standard method.
B.2 reagents and solutions
Chloroform (or dimethylformamide);
Pyrimethanil Sample. a known mass fraction, w≥98.0%;
Internal standard. n-butyl phthalate, should not interfere with the analysis of impurities;
Internal standard solution. Weigh di-n-butyl phthalate, 3.5g, was placed 250mL volumetric flask with chloroform (or dimethylformamide)
Dissolved and diluted to the mark.
B.3 Instruments
GC. a hydrogen flame ionization detector;
Chromatography or chromatography workstation processor;
Column. 30m × 0.32mm (id) capillary column bonded HP-5 (5% phenyl methyl silicone), film thickness 0.25μm.
B.4 GC operating conditions
Temperature. column temperature 180 ℃, the gasification chamber 250 ℃, the detector chamber 260 ℃;
Gas flow rate. carrier gas (N2) 2.0mL/min, hydrogen 30mL/min, air 300mL/min;
Injection volume. 1.0μL;
Retention time. pyrimethanil 3.9min, internal standard 6.3min.
The above-described gas chromatographic operating conditions typical system operating parameters. May be given operating parameters make appropriate adjustments characteristics of different instruments to
Obtain the best result. Typical pyrimethanil the drug and internal standard gas chromatography is shown in Figure B.1.
1 --- pyrimethanil;
2 --- internal standard.
Figure B.1 pyrimethanil the drug and internal standard GC FIG.
Measuring step B.5
B.5.1 preparation of standard solution
Weigh 0.05 g of pyrimethanil standard (accurate to 0.0001g), was placed in a glass bottle with a stopper, with a pipette 5mL was added to the standard solution,
Shake well.
B.5.2 prepared sample solution
Weigh a sample contains about 0.05 g of pyrimethanil (accurate to 0.0001g), and placed in a stoppered glass bottle, with a pipette 5mL was added to the standard solution
Liquid, shake.
B.5.3 Determination
Under the above operating conditions, the instrument until a stable baseline, the number of consecutive doses of the standard solution is injected, the needle was calculated for each pyrimethanil internal standard peak area
When the ratio of repeatability, to be the relative change pyrimethanil two needles internal standard peak area ratio of less than 1.2% is adjacent, in accordance with standard sample solution, the sample
Solution, the sample solution and standard solution were sequentially measured.
B.6 computing
The two pins of the sample solution and the two measured doses of the standard solution of pyrimethanil and internal standard peak area ratio of the sample before and after averaging, respectively.
Pyrimethanil sample mass fraction amine according to formula (B.1) is calculated.
w1 = r2
· M1 · w
r1 · m2
(B.1)
Where.
W1 --- pyrimethanil sample mass fraction in%;
R2 --- sample solution, pyrimethanil and average internal standard peak area ratio;
M1 --- Sample mass in grams (G);
W --- Sample pyrimethanil amine content, expressed in%;
R1 --- the standard solution, pyrimethanil and average internal standard peak area ratio;
--- M2 sample mass, in grams (g).
B.7 allow poor
The measurement results of the two parallel error should not exceed 1.2%, and the arithmetic mean value as a measurement result.
......
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