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GB 22609-2008: Carbosulfan Technical
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Carbosulfan Technical
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GB 22609-2008
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Basic data | Standard ID | GB 22609-2008 (GB22609-2008) | | Description (Translated English) | Carbosulfan Technical | | Sector / Industry | National Standard | | Classification of Chinese Standard | G25 | | Classification of International Standard | 65.100.10 | | Word Count Estimation | 8,884 | | Date of Issue | 2008-12-17 | | Date of Implementation | 2009-06-01 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 21 of 2008 (No. 134 overall) | | 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 the carbosulfan original drug requirements, test methods and marking, labeling, packaging, storage and transportation. This standard applies to carbosulfan and its impurities generated in the production of carbosulfan original drug. | GB 22609-2008: Carbosulfan Technical---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.
Carbosulfan Technical
ICS 65.100.10
G25
National Standards of People's Republic of China
Carbosulfan TC
Published 2008-12-17
2009-06-01 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 modification uses standard FAO Specification 417/T C/S/F (1991) "carbosulfan TC" (in English).
This standard modification method using foreign advanced standards for the redrafted law.
This standard FAO Specifications "carbosulfan TC" major technical differences.
1) The standard carbosulfan quality score is ≥90%, FAO specifications ≥890g/kg (≥89%).
2) The standard control carbofuran impurity content is ≤0.2%, FAO specifications ≤2g/kg (≤0.2%).
3) The control standard acetone insoluble impurity content, FAO specifications without the indicators.
4) the actual quality of our products overall situation, alkalinity index of ≤0.05%, while FAO specifications for ≤0.2g/kg (≤0.02%).
The standard proposed by China Petroleum and Chemical Industry Association.
This standard by the National Pesticide Standardization Technical Committee (SAC/TC133).
This standard is drafted. Shenyang Chemical Research Institute.
Participated in the drafting of this standard. Hunan Haili Chemical Industry Co., Ltd., Jiangsu Changlong Chemical Co., Ltd., Zhejiang Hetian Chemical Co.
the company.
The main drafters of this standard. High Scenic, Zan Yan Kun, Zheng Jingyu, Zhang Zhongze, Han Ping, Chen Ping, Yu Shuying.
Carbosulfan TC
The active ingredient other product names, structural formulas and physicochemical parameters carbosulfan substantially as follows.
ISO common name. Carbosulfan
CIPAC Numeric Code. 417
Chemical name. 2,3-dihydro-2,2-dimethyl-7-yl (dibutylamino) methyl carbamate.
Structure
Handkerchief handkerchief handkerchief
Division division division
division division division
O C
N
CH
S N
(CH2) 3CH3
(CH2) 3CH3
OH3C
H3C
Empirical formula. C20H32N2O3S
Molecular weight. 380.5 (according to 2007 international relative atomic mass)
Biological activity. insecticide
Boiling point. 124 ℃ ~ 128 ℃
Vapor pressure (25 ℃). 0.041mPa
Solubility (25 deg.] C). water 0.3mg/L, and most immiscible organic solvent, such as. xylene, n-hexane, chloroform, methylene chloride, ethyl
Alcohol, methanol, acetone, etc.
Stability. Hydrolysis, DT50 (25 ℃) in aqueous solution is less than in pure water 1h (pH4), 22h (pH6), 7.6d (pH7),
14.2d (pH8), 14.2d (pH8), greater than 58.3d (pH9)
Range 1
This standard specifies the requirements carbosulfan original drug, Test Method for marking, labeling, packaging, storage and transportation.
This standard applies to impurities derived from carbosulfan composition and production of the original drug carbosulfan.
2 Normative references
Terms of the following documents become provisions of this standard by reference in this standard. For dated reference documents, all later
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to agreements based on this standard
Whether the latest versions of these documents. For undated references, the latest version applies to this standard.
Preparation GB/T 601 standard titration solution Chemicals
GB/T 1600-2001 Pesticide moisture determination method
GB/T 1604 pesticide regulations for acceptance of goods
GB/T 1605-2001 sampling commercial pesticides
GB 3796 pesticide packaging General
GB/T 19138 Determination of acetone insoluble pesticide
3.1 Appearance
This product should be a brown viscous liquid.
3.2 Technical Specifications
Carbosulfan original drugs should meet the requirements of Table 1.
Table 1 carbosulfan original drug control programs Index
Item Index
Carbosulfan mass fraction /% ≥ 90.0
Carbofuran mass fraction /% ≤ 2.0
Mass acetone insoluble fraction a /% ≤ 0.2
Moisture content /% ≤ 0.2
Alkalinity (as NaOH) /% ≤ 0.05
When a normal production, the acetone insoluble matter content measured at least once every three months.
Test Method 4
4.1 Sampling
Carried out in GB/T 1605-2001 of "original drug sampling" approach. Determining Sample packages with a random number table method; final sample volume should not be
Less than 100g.
4.2 Identification Test
HPLC --- This identification test can be carried out simultaneously with the measurement of the content of carbosulfan. In the same chromatographic operating conditions
Next, a peak retention time of a sample solution and the standard solution carbosulfan peak retention time, which should be in the relative difference
1.5% or less.
Infrared Spectroscopy Infrared --- sample and standard sample in the range of 4000cm-1 ~ 400cm-1 absorption spectrum should be no significant difference. Ding
Carbosulfan standard infrared spectra of Figure 1.
FIG 1 carbosulfan standard infrared spectra
Determination of the mass fraction of 4.3 carbosulfan (carbofuran)
4.3.1 Method summary
Sample was dissolved in methanol, methanol + water as the mobile phase, used as a filler AgilentTC-C18 stainless steel column and UV detector
(280 nm), the sample carbosulfan (carbofuran) reverse phase high performance liquid chromatography, external standard.
4.3.2 Reagents and solutions
Methanol. HPLC grade;
Water. The new secondary steam distilled water;
Carbosulfan Sample. A known mass fraction ≥98.0%.
Carbofuran Sample. A known mass fraction ≥99.0%.
Carbofuran Preparation of standard solution. Weigh 0.05 g of carbofuran standard (accurate to 0.0002g) was placed in a 50mL volumetric flask, washed with methanol
Dissolved and diluted to the mark.
4.3.3 Instruments
HPLC. a variable wavelength UV detector;
Chromatographic data processor or workstation;
Column. 250mm × 4.6mm (i.d.) Stainless steel column, built AgilentTC-C18,5μm filler (column or with equivalent effect);
Filter. membrane pore size of about 0.45 m;
Microsyringe. 50μL;
Quantitative sampling tube. 5μL;
Ultrasonic cleaning.
4.3.4 HPLC operating conditions
Mobile phase. [Psi] (methanol. water) = 88.12, by membrane filtration, and degassing;
Flow rate. 1.0mL/min;
Column temperature. room temperature (temperature change should be less than 2 deg.] C);
Detection wavelength. 280nm;
Injection Volume. 5μL;
Retention time. 3.6min carbofuran, carbosulfan 13.8min.
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.
A typical carbosulfan HPLC TC shown in Figure 2.
1 --- carbofuran;
2 --- carbosulfan.
FIG 2 FIG carbosulfan HPLC original drug
4.3.5 Determination Step
4.3.5.1 Preparation of standard solution
Weigh 0.1 g of carbosulfan standard (accurate to 0.0002g), a 50mL volumetric flask, dissolve and dilute to volume with methanol,
Shake well. Pipette accurately pipetted solution is placed above another 10mL 50mL volumetric flask, and then another 2mL pipette take g
Budweiser standard solution in the same volumetric flask, dilute to volume with methanol, shake.
4.3.5.2 Preparation of sample solution
Weigh containing 0.1 g of carbosulfan (accurate to 0.0002g) sample, placed in a 50mL volumetric flask, dissolved in methanol and diluted to the mark with
Degree, shake. Pipette accurately pipetted solution is placed above another 10mL 50mL volumetric flask, diluted with methanol to the mark.
4.3.5.3 Determination
Under the above operating conditions, after the instrument is stable, the number of consecutive doses of the standard solution is injected until the needle carbosulfan two adjacent opposing peak area
After the change is less than 1.0%, measured according to the standard solution, sample solution, the sample solution, the order of standard solution.
4.3.6 computing
The two doses of the standard peak area was measured before and after the two needles in the sample solution and a sample carbosulfan (carbofuran peak area) were
Averaged. Sample carbosulfan (carbofuran) is a mass fraction (%), according to equation (1).
1 = A2
(1)
Where.
A1 --- the standard solution, a peak area carbosulfan (carbofuran peak area) is calculated;
A2 --- sample solution, carbosulfan peak area (carbofuran peak area) is calculated;
--- standard samples carbosulfan (carbofuran) mass fraction, expressed in%;
4.3.7 allows poor
The measurement results of the mass fraction of carbosulfan two parallel should be less than 1.5%, mass fraction of parallel measurement results twice carbofuran
The difference should not be more than 0.2%, and the arithmetic mean value as a measurement result.
4.4 Determination of acetone insolubles
GB/T 19138 Determination press.
4.5 Determination of Moisture
According to the GB/T he 1600-2001 "Karl Fischer method" T "2.1.2 Karl Fischer - coulometric titration instrument measurement method".
4.6 Determination of alkalinity
4.6.1 Reagents and solutions
Volume fraction of 95% ethanol;
HCl Standard Solution Ba (HCl) = 0.02mol/L, according to GB/T 601 and calibration formulation;
Methyl red ethanol solution. ρ (methyl red) 2g/L;
Bromocresol green ethanol solution. ρ (Bromocresol Green) 1g/L;
Mixed indicator. [Psi] (methyl red ethanol solution. bromocresol green ethanol solution) = 1.3.
4.6.2 Determination Step
2g sample was weighed (accurate to 0.0002g), placed in a 250mL Erlenmeyer flask, 95% ethanol was added 100mL, shaking the sample
Dissolved. Add 5 drops of mixed indicator, titration with a standard solution of hydrochloric acid titration, the solution turns from green to yellow is the end. Meanwhile blank
Determination.
4.6.3 computing
2 alkalinity (%) of the sample, according to equation (2).
2 = Ba
(Qiao Qiao 1- 0) M
100 (2)
Where.
--- Ba actual concentration of hydrochloric acid standard titration solution in units of moles per liter (mol/L);
Qiao 1 --- titration of the sample solution, the consumption volume of standard HCl titration solution in milliliters (mL);
V0 --- titrate blank solution, the consumption volume of standard HCl titration solution in milliliters (mL);
--- numerical molar mass M sodium hydroxide (NaOH), in units of grams per mole (g/mol) (M = 40).
4.7 product testing and acceptance
Shall comply with the provisions of GB/T 1604's. Process limit values, the comparison value using the rounding method.
5 marking, labeling, packaging, storage and transportation
5.1 carbosulfan sign the original drug, labeling, packaging, should comply with the provisions of GB 3796.
5.2 Application of carbosulfan TC polyethylene plastic lined metal pail or bucket, barrel net content should be less than 200kg.
5.3 protocol based on user requirements or orders, may take other forms of packaging, it should comply with the provisions of GB 3796.
5.4 carbosulfan original drug package airiness, dry place.
5.5 storage and transportation to prevent moisture and sunlight, no food, seed, feed mix, avoid contact with skin, eyes, nose and mouth to prevent inhalation.
5.6 Security. CARBOSULFAN is moderately toxic pesticides. The FDA should wear protective gloves, masks, wear clean protective clothing. After use should stand
I.e., wash with water and soap. Such as poisoning occurs, it is timely to hospital for treatment.
5.7 Acceptance period. CARBOSULFAN original drug acceptance period of one month. From the date of delivery, within a month, complete product quality inspection, which each
Indicators should meet the standards.
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