GB 22609-2008 English PDF

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GB 22609-2008: Carbosulfan Technical
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 22609-2008	189	Add to Cart	3 days	Carbosulfan Technical	Valid

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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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