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GB 28128-2011: [GB/T 28128-2011] Thiosultap-monosodium technical material
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[GB/T 28128-2011] Thiosultap-monosodium technical material
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GB 28128-2011
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Basic data | Standard ID | GB 28128-2011 (GB28128-2011) | | Description (Translated English) | [GB/T 28128-2011] Thiosultap-monosodium technical material | | Sector / Industry | National Standard | | Classification of Chinese Standard | G25 | | Classification of International Standard | 65.100.10 | | Word Count Estimation | 10,131 | | Date of Issue | 2011-12-30 | | Date of Implementation | 2012-04-15 | | Quoted Standard | GB/T 601; GB/T 1601; GB/T 1604; GB/T 1605-2001; GB 3796 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 23 of 2011 | | 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 requirements Monosultap original drug, test methods and marking, labeling, packaging, storage and acceptance period. This standard applies to Monosultap its impurities generated in the production of Monosultap original drug. | GB 28128-2011: [GB/T 28128-2011] Thiosultap-monosodium 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.
Thiosultap-monosodium technical material
ICS 65.100.10
G25
National Standards of People's Republic of China
Monosultap original drug
Issued on. 2011-12-30
2012-04-15 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
The standard Chapter 3, Chapter 5 is mandatory, the rest are recommended.
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
The standard proposed by China Petroleum and Chemical Industry Association.
This standard by the National Standardization Technical Committee on Pesticides (SAC/TC133) centralized.
This standard is drafted by. Shenyang Chemical Research Institute Co., Ltd.
Participated in the drafting of this standard. Jiang Su Tianrong Group Co., Ltd. Zhejiang Bo Shida crop, Jiangsu Ampang electrochemical
Limited.
The main drafters of this standard. Meibao Gui, Zhangxue Bing, Wang Qiang, Xu Liting, Jiang Yutian, Li Maoqing.
Monosultap original drug
1 Scope
This standard specifies the requirements Monosultap original drug, test methods and marking, labeling, packaging, storage and acceptance period.
This standard applies to the impurities generated by the production and composition of Monosultap Monosultap original drug.
Note. Other name, structural formula and basic physicochemical parameters Monosultap see Appendix A.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Preparation of GB/T 601 chemical reagent standard titration solution
Determination of GB/T 1601 Pesticides pH value
GB/T 1604 Goods pesticide regulations for acceptance
GB/T 1605-2001 Sampling Method commercial pesticides
GB 3796 pesticide packaging General
3 Requirements
3.1 Appearance
White powdery solid.
3.2 Technical Specifications
Monosultap original drug should also meet the requirements of Table 1.
Table 1 Monosultap original drug control project indicators
Item Index
Monosultap mass fraction /% ≥ 95.0
Sodium chloride mass fraction /% ≤ 2.0
Loss on drying /% ≤ 1.0
a pH range of 4.0 to 5.5
Test Method 4
4.1 Sampling
According to GB/T 1605-2001 "on the original drug product sampling" approach. Determined by sampling a random number table method packages, the final sample size
Not less than 100g.
4.2 Identification Test
You can choose one of the following methods. When not identify one way, then use another method should be determined.
HPLC --- The identification test can be carried out simultaneously with the determination of the mass fraction of Shachongdan. In the same chromatographic operating conditions
, The sample solution to a chromatographic retention time and Monosultap standard solution Shachongdan chromatographic retention time, the relative difference should
1.5% or less.
Infrared spectroscopy --- Monosultap sample and standard samples in the infrared range 4000cm-1 ~ 400cm-1 absorption spectrum should be no significant difference
different. Monosultap standard infrared spectrum is shown in Figure 1.
Figure 1 Monosultap standard infrared spectrum
4.3 Determination of the mass fraction of Shachongdan
4.3.1 Method summary
Sample dissolved in mobile phase, methanol aqueous potassium dihydrogen phosphate (pH7.0) as the mobile phase, to use as filler AgilentTCC18
Stainless steel column and UV detector (220nm), the sample of Shachongdan reverse phase high performance liquid chromatography, external standard.
4.3.2 Reagents and solutions
Methanol. HPLC grade;
Water. The new secondary steam distilled water;
Potassium hydroxide solution. c (KOH) = 2mol/L;
Potassium dihydrogen phosphate. c (KH2PO4) = 0.035mol/L, potassium hydroxide solution with a pH value adjusted to 7.0;
Monosultap standard. a known mass fraction w≥99.0%.
4.3.3 Instruments
High performance liquid chromatography. a variable wavelength UV detector;
Chromatographic data processor or chromatography workstation;
Column. 250mm × 4.6mm (id) stainless steel column, built AgilentTCC18,5μm filler (or with equivalent effect color
The column);
Filter. filter pore size of about 0.45μm;
Micro injector. 50μL;
Quantitative sample line. 10μL;
Ultrasonic cleaner.
4.3.4 HPLC operating conditions
Mobile phase. Ψ (methanol. potassium dihydrogen phosphate) 5.95, with 0.45μm filter membrane, ultrasound 10min spare;
Flow rate. 1.0mL/min;
Column temperature. room temperature (temperature change should not exceed 2 ℃);
Detection wavelength. 220nm;
Injection volume. 10μL;
Retention time. 5.5min.
It said operating parameters are typical, according to the characteristics of different instruments, given operating parameters adjusted as appropriate, in order to obtain the best results.
Typical Monosultap original drug HPLC is shown in Figure 2.
1 --- Monosultap.
Figure 2 Figure Shachongdan HPLC original drug
4.3.5 measuring step
4.3.5.1 Preparation of standard solution
Weigh 0.1g (accurate to 0.0002g) Shachongdan standard, a 50mL volumetric flask, dissolved in mobile phase and dilute to the mark,
Shake well.
4.3.5.2 Preparation of sample solution
Take a sample containing said Monosultap 0.1g (accurate to 0.0002g), and a 50mL volumetric flask, dissolved in mobile phase and dilute to the mark
Degree, shake.
4.3.5.3 Determination
Under these operating conditions, after the instrument is stable, continuous injection of several doses of the standard solution until the two adjacent needles Monosultap peak area relative change
After less than 1.2%, according to the solution, the sample solution, the sample solution and standard sequence of the standard solution was measured.
4.3.5.4 Calculation
The two needle sample solution and measured before and after the two doses of the standard sample solution Monosultap peak areas are averaged. Sample Monosultap
Mass fraction according to equation (1).
w1 = A2
· M1 · w
A1 · m2
(1)
Where.
w1 --- sample Shachongdan mass fraction, expressed as a percentage;
A2 --- sample solution Monosultap mean peak area;
Sample mass m1 --- Shachongdan in grams (g);
w --- Monosultap standard samples Shachongdan mass fraction, expressed as a percentage;
A1 --- Sample mean peak area in Monosultap solution;
m2 --- sample mass, in grams (g).
4.3.6 allowable difference
Monosultap poor quality score of two parallel determination results shall not be greater than 1.2%, the arithmetic mean value as a measurement result.
4.4 Determination of the mass fraction of sodium chloride
4.4.1 Method summary
Samples dissolved in water, with nitric acid and hydrogen peroxide to destroy thiosulfate and Monitoring for interfering substances, with its ferric ammonium sulfate for directions
Agents, sodium chloride content was measured using the method of silver.
4.4.2 Reagents and solutions
Sucrose solution. ρ = 250g/L;
Silver nitrate standard solution. c (AgNO3) = 0.1mol/L (according to GB/T 601 preparation);
Ammonium thiocyanate standard titration solution. c (NH4SCN) = 0.1mol/L (according to GB/T 601 preparation);
Nitric acid solution. φ (HNO3) = 50%;
Hydrogen peroxide solution. w (H2O2) = 30%;
Ammonium ferric sulfate saturated solution (add 3 to 5 drops of sulfuric acid drops).
4.4.3 Determination
Weigh 0.5g sample (accurate to 0.0002g), placed in 250mL conical flask, nitric acid solution 40mL, 10mL hydrogen peroxide
Solution and 80mL water, heating micro-boiling 10min, cooled to room temperature. Burette with the standard solution of silver nitrate was added 15mL, shake. Join
8mL sucrose solution, shaken vigorously 2min, add 1mL ferric ammonium sulfate indicator under shaking with ammonium thiocyanate standard titration solution titrated to
The solution was light brown to red, and kept unchanged at the end of 30s.
4.4.4 Calculation
Sample mass fraction of sodium chloride according to formula (2).
w2 =
(C1 · V1-c2 · V2) · M
m × 1000 × 100
(2)
Where.
w2 --- sample of sodium chloride mass fraction, expressed as a percentage;
c1 --- the actual concentration of silver nitrate standard solution, the unit is mol per liter (mol/L);
Vl --- standard solution of silver nitrate by volume in milliliters (mL of);
c2 --- the actual concentration of ammonium thiocyanate standard titration solution, expressed in moles per liter (mol/L);
V2 --- consumption volume of ammonium thiocyanate standard titration solution, in milliliters (mL);
--- The M NaCl molar mass in grams per mole (g/mol), [M (NaCl) = 58.45];
M --- the quality of the sample, in grams (g).
4.5 Determination of the mass fraction of loss on drying
4.5.1 Instruments
Oven. 105 ℃ ± 2 ℃;
Weighing bottle. diameter 70mm, height 40mm;
Dryer.
4.5.2 measuring step
The weighing bottle placed in an oven bake 1h, was brought out in a desiccator to cool to room temperature, weigh (accurate to 0.0002g). Repeat the above steps
Step, until constant weight weighing bottle. Place the sample in the bottle 2g, paving, weighed (accurate to 0.01g), the weighing bottle placed in an oven, without
Cover and bake 1h, remove and put in the dryer to cool to room temperature, weighed (accurate to 0.0002g).
4.5.3 Calculation
Loss on drying of the sample according to equation (3) Calculated.
w3 = m1-m2m × 100
(3)
Where.
W3 --- Loss on drying of the sample, expressed in%;
Mass m1 --- weighing bottle and sample before drying, in grams (g);
Mass m2 --- weighing bottle and sample after drying, in grams (g);
M --- the quality of the sample, in grams (g).
4.5.4 allowable difference
The relative deviation of two parallel determination results shall not be greater than 30%; the arithmetic mean value as a measurement result.
Determination of 4.6 pH value
According to GB/T 1601 carried out.
4.7 product testing and acceptance
Shall comply with GB/T 1604 regulations limit the use of numerical processing rounding value comparison method.
5 marking, labeling, packaging, storage, security, acceptance of
5.1 marking, labeling, packaging
Flag Monosultap original drug, labeling, packaging shall comply with the provisions of GB 3796; Monosultap original drug application of clean, dry polypropylene bucket bag
Equipment, net weight 25kg per barrel or 50kg; use other forms of packaging according to user requirements or the order agreement, subject to GB 3796
Provisions.
5.2 Storage
Monosultap original drug package should be stored in ventilated, dry warehouse; storage and transportation to prevent moisture and sunlight, no food, seed, feed
Mix, avoid contact with skin, eyes, mouth and nose to prevent inhalation.
5.3 Security
Nereistoxin Monosultap is a moderately toxic pesticides. Toxic if swallowed or inhaled all, it can penetrate through the skin. The FDA
You should wear protective gloves, gas masks, wear clean protective clothing. After application, immediately wash with soap and water. In case of poisoning, immediately
Sent to hospital for treatment, the antidote atropine; do artificial respiration if necessary.
5.4 Acceptance of
Monosultap original drug acceptance period is one month. From the date of delivery, the quality of the finished product acceptance within one month, the indicators should be consistent
standard requirement.
Appendix A
(Informative)
Monosultap Other name, structural formula and basic physicochemical parameters
Other name, structural formula and basic physicochemical parameters of the active ingredients of this product Monosultap follows.
Generic Name. Monosultap
ISO common name. Thiosultap-monosodium
Chemical Name. Dimethyl monohydrate - Hydrogen-2- (1,3-disulfonate monosodium sulfopropyl) ammonium
Structure.
H3C
H3C
CH
CH2-SSO-3
CH2-SSO-3
(Na) 2 · H2O
Empirical formula. C5H14NO7S4Na
Molecular Weight. 351.42
Biological activity. Insecticidal
Melting point. 142.5 ℃ (decomposition)
Solubility (g/L, 25 ℃). 500 water, 20 of methanol, acetone and 2.5 × 10-4
Stability. at 50 ℃ sealed storage stability.
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