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GB 22170-2008: [GB/T 22170-2008] Pyrazosulfuron-ethyl wettable powder
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[GB/T 22170-2008] Pyrazosulfuron-ethyl wettable powder
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GB 22170-2008
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Basic data | Standard ID | GB 22170-2008 (GB22170-2008) | | Description (Translated English) | [GB/T 22170-2008] Pyrazosulfuron-ethyl wettable powder | | Sector / Industry | National Standard | | Classification of Chinese Standard | G25 | | Classification of International Standard | 65.100.20 | | Word Count Estimation | 8,841 | | Date of Issue | 2008-07-11 | | Date of Implementation | 2009-01-01 | | Quoted Standard | GB/T 1600; GB/T 1601; GB/T 1604; GB/T 1605-2001; GB 3796; GB/T 5451; GB/T 14825; GB/T 16150; GB/T 19136 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 12 of 2008 (No. 125 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 topiramate ethyl WP requirements, test methods and marking, labeling, packaging, storage and transportation. This standard applies to the original drug topiramate ethyl, fillers and additives suitable for the processing of topiramate ethyl WP. | GB 22170-2008: [GB/T 22170-2008] Pyrazosulfuron-ethyl wettable powder---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.
Pyrazosulfuron-ethyl wettable powder
ICS 65.100.20
G25
National Standards of People's Republic of China
Topiramate ethyl WP
Posted 2008-07-11
2009-01-01 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 are mandatory, the rest are recommended.
The standard proposed by China Petroleum and Chemical Industry Association.
This standard by the National Standardization Technical Committee on Pesticides (CSBTS/T C133) centralized.
This standard is drafted by. Shenyang Chemical Research Institute.
The main drafters of this standard. to Xu Wei, Xing Hong, Zhang Xuebing.
The standard commission Secretariat of National Pesticide Standardisation Technical Committee responsible for the interpretation.
Topiramate ethyl WP
Other active ingredients of the product name, structural formula and basic physicochemical parameters topiramate ethyl follows.
ISO common name. pyrazosulfuron-ethyl
CAS Registry Number. [93697-74-6]
Chemical name. 5- (4,6-dimethoxy-pyrimidin-2-yl-carbamoyl aminosulfonyl) -1-methylpyrazole-4-carboxylate
Structure.
Empirical formula. C14H18N6O7S
Molecular Weight. 414.4 (according to 2005 international relative atomic mass)
Biological activity. weeding
Melting point. 181 ℃ ~ 182 ℃
Vapor pressure (20 ℃). 14.7μPa
Solubility (20 ℃, g/L). 0.0145 of water, methanol, 0.7, 0.2 hexane, benzene, 15.6, 234.4 chloroform, acetone 31.7
Stability. stable at 50 ℃ for 6 months; at pH = 7 relatively stable, unstable in acidic or alkaline medium
1 Scope
This standard specifies the topiramate ethyl wettable powders requirements, test methods and marking, labeling, packaging, storage and transportation.
This standard applies to the processing by the original drug topiramate ethyl, fillers and additives made of a suitable topiramate ethyl wettable powder.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 1600 Determination of Water Pesticides
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
GB/T 5451 WP Pesticide wettability measurement method
GB/T 14825 method for determination of pesticide suspension
GB/T 16150 pesticide powder, wettable powder fineness measurement method
GB/T 19136 Determination of Pesticide Thermal storage stability
3 Requirements
3.1 Composition and appearance. This product should meet the standards of the original drug topiramate ethyl with suitable additives and fillers processed and, as an integral loose uniform
Powder, there should be no lumps.
3.2 topiramate ethyl WP should meet the requirements of Table 1.
Table 1 topiramate ethyl WP Control Project Index
Item Index
Topiramate ethyl mass fraction /% 7.5 ± 0.8 10.0 ± 1.0
Suspension rate /% ≥ 75
Moisture /% ≤ 2.0
pH range of 5.0 to 8.0
Wetting time/s ≤ 90
Fineness (through 44μm standard sieve) /% ≥ 98
Thermal storage stability test a qualified
When a normal production, heat storage stability test every three months at least once.
Test Method 4
4.1 Sampling
According to GB/T 1605-2001 "on solid preparation sampling" approach. Determining sample package using a random number table method; the final sample size
Not less than 300g.
4.2 Identification Test
HPLC --- The identification test can be carried out simultaneously with the determination of topiramate ethyl content. Under the same chromatographic operating conditions,
Retention time with the standard solution in the sample solution to a peak of topiramate ethyl chromatographic retention time, the relative difference should be 1.5%
Fewer.
4.3 topiramate ethyl mass fraction determination
4.3.1 Method summary
Samples dissolved in methanol, methanol - water as the mobile phase, use ODSHypersil, 5μm as filler columns and variable wavelength UV
Detectors, sample of topiramate ethyl liquid chromatography separation and determination.
4.3.2 Reagents and solutions
Methanol. HPLC grade;
Water. The new secondary steam distilled water;
Topiramate ethyl standard. a known mass fraction ≥98.0%.
4.3.3 Instruments
LC. a variable wavelength UV detector and quantitative injection valve;
Chromatographic data processor or chromatography workstation;
Column. 4.6mm (i.d.) × 200mm stainless steel column, built ODSHypersil, 5μm filler (or with the same column efficiency
Other reversed phase columns);
Filter. filter pore size of about 0.45μm;
Ultrasonic bath;
Micro Injector. not less than 50μL.
4.3.4 HPLC operating conditions
Mobile phase. ψ (CH3OH.H2O) = 70.30 (adjusted with phosphoric acid to pH = 3);
The mobile phase flow rate. 1.0mL/min;
Column temperature. room temperature (temperature change should not exceed 2 ℃);
Detection wavelength. 241nm;
Injection volume. 10μL;
Retention time. topiramate ethyl approximately 8.0min.
HPLC operating conditions described above, the Department of typical operating parameters. According to the characteristics of different instruments, given operating parameters adjusted as appropriate,
In order to obtain the best results. Typical liquid chromatogram topiramate ethyl WP shown in Figure 1.
1 --- topiramate ethyl.
Figure 1 topiramate ethyl WP liquid chromatogram
4.3.5 measuring step
4.3.5.1 preparation of standard solution
Weigh topiramate ethyl standard 0.05g (accurate to 0.0002g), placed in 100mL flask, add 80mL of methanol, add ultrasound
Wave bath sonication 5min. Remove cooled to room temperature, add methanol to volume, shake; pipette imbibe 10.00mL, set
In a 50mL volumetric flask, add methanol to volume, shake.
4.3.5.2 preparation of the sample solution
Weigh containing topiramate ethyl 0.05g sample (accurate to 0.0002g), a 50mL volumetric flask, add 40mL of methanol, into
Ultrasonic bath sonication 5min. Removed, cooled to room temperature, add methanol to volume, shake; a membrane pore size of more than about 0.45μm
Filter.
4.3.5.3 Determination
Under the above chromatographic operating conditions, after the instrument is stable, continuous injection of several doses of the standard solution until the two adjacent needles topiramate ethyl relative peak area
After the change of less than 1.0%, according to the order of the standard solution, sample solution, sample solution, standard solution injection analysis.
4.3.6 Calculation
The two needle sample solution measured before and after the peak area of the sample and two doses of the standard solution of ethyl topiramate were averaged. Sample topiramate
Ethyl mass fraction of 1 (%) according to equation (1).
1 =
(1)
Where.
A1 --- standard solution Metsulfuron mean peak area pyrazosulfuron;
A2 --- sample solution topiramate ethyl Metsulfuron mean peak area;
--- Topiramate ethyl standard samples topiramate ethyl mass fraction, expressed as a percentage.
4.3.7 allowable difference
The difference between two parallel determination results shall not be greater than 0.3%, the arithmetic mean value as a measurement result.
4.4 Determination of the suspension rate
4.4.1 measuring step
According to GB/T 14825 performed. Weigh containing topiramate ethyl 0.10g sample (accurate to 0.0002g). With 60mL methanol cylinder
The remaining 25mL of the suspension and the precipitate was all transferred to a 100mL flask, under ultrasonic oscillation 5min, cooled to room temperature,
Methanol was added to volume, shake; filtered through a membrane filter pore size of about 0.45μm. 4.3 Determination by which topiramate ethyl quality.
4.4.2 Calculation
Suspension rate 2 (%) is calculated as follows.
2 =
× 111.1 (2)
A1 × 5
(4)
Where.
A1 --- standard solution Metsulfuron mean peak area pyrazosulfuron;
A2 --- sample solution by the remaining 25mL suspension and precipitate formulated in topiramate ethyl mean peak area;
1 --- sample topiramate ethyl mass fraction, expressed as a percentage;
--- Topiramate ethyl standard samples topiramate ethyl mass fraction, expressed as a percentage.
4.4.3 allowable difference
The difference between two parallel determination results shall not be greater than 5% of the arithmetic mean as a measurement result.
4.5 Determination of Moisture
According to GB/T 1600 in the "azeotropic distillation" method.
According to GB/T 1601 carried out.
4.7 Determination of wetting time
According to GB/T 5451 carried out.
4.8 fineness
According to GB/T 16150 in the "wet sieve method".
4.9 Thermal storage stability test
According to GB/T 19136 in "powder formulations" to. After the heat storage mass fraction of topiramate ethyl, suspension rate is still 3.2 shall comply with the requirements.
4.10 Product inspection and acceptance
Shall comply with GB/T 1604's. Limit numerical processing using rounding value comparison method.
5 marking, labeling, packaging, storage and transportation
5.1 topiramate ethyl WP signs, labels, packaging, should meet the requirements of GB 3796.
5.2 topiramate ethyl WP application of clean, dry, lined with plastic woven bag, net weight 25kg.
5.3 According to user requirements or ordering agreement, you can use other forms of packaging, subject to the provisions of GB 3796.
5.4 topiramate ethyl WP package should be stored in well-ventilated, dry coffers.
5.5 storage, prevent moisture and sunlight, no food, seed, feed mix, avoid contact with skin, eyes, mouth and nose to prevent inhalation.
5.6 Safety. This product is a low-toxic pesticides sulfonylurea, are swallowed and inhaled toxic. When using this product to wear goggles and rubber gloves, wear the necessary
Protective clothing. Such as skin, eyes accidentally stained with the product, rinse immediately with plenty of water. Coverage were immediately sent to hospital for treatment.
5.7 Warranty. under the specified storage conditions, warranties of topiramate ethyl wettable powders, counting from the date of production for 3 years.
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