GB 28128-2011 English PDF

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GB 28128-2011: [GB/T 28128-2011] Thiosultap-monosodium technical material
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 28128-2011	259	Add to Cart	3 days	[GB/T 28128-2011] Thiosultap-monosodium technical material	Valid

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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

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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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