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GB 22168-2008: [GB/T 22168-2008] Pyrazosulfuron-ethyl technical
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| GB 22168-2008 | English | 209 |
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[GB/T 22168-2008] Pyrazosulfuron-ethyl technical
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GB 22168-2008
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Basic data | Standard ID | GB 22168-2008 (GB22168-2008) | | Description (Translated English) | [GB/T 22168-2008] Pyrazosulfuron-ethyl technical | | Sector / Industry | National Standard | | Classification of Chinese Standard | G25 | | Classification of International Standard | 65.100.20 | | Word Count Estimation | 8,817 | | Date of Issue | 2008-07-11 | | Date of Implementation | 2009-01-01 | | Quoted Standard | GB/T 1601; GB/T 1604; GB/T 1605-2001; GB 3796; GB/T 19138 | | 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 original drug topiramate ethyl requirements, test methods and marking, labeling, packaging, storage and transportation. This standard applies to topiramate ethyl and impurities generated in the production of ethyl original drug topiramate. | GB 22168-2008: [GB/T 22168-2008] Pyrazosulfuron-ethyl 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.
Pyrazosulfuron-ethyl technical
ICS 65.100.20
G25
National Standards of People's Republic of China
Original drug topiramate ethyl
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.
Original drug topiramate ethyl
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 requirements of topiramate ethyl original drug, test methods and marking, labeling, packaging, storage and transportation.
This standard applies to impurities in the topiramate ethyl and generated in the production of the composition of the original drug topiramate ethyl.
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.
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 19138 Determination of acetone insoluble pesticide
3 Requirements
3.1 Composition and appearance. This product should topiramate ethyl and related production impurities, should be white to yellow solid, no visible foreign matter and
Filling modifier.
3.2 original drug topiramate ethyl shall comply with the requirements in Table 1.
Table 1 ethyl topiramate original drug quality control program indicators
Item Index
Topiramate ethyl mass fraction /% ≥ 95.0
Loss on drying /% ≤ 1.0
pH range 4.0 to 8.0
Dichloromethane insoluble matter a /% ≤ 0.5
a dichloromethane insoluble matter was measured at least once every three months.
Test Method 4
4.1 Sampling
According to GB/T 1605-2001 "on the original drug product sampling" approach. Determining sample package using a random number table method; the final sample size
Not less than 250g.
4.2 Identification Test
IR spectra of infrared spectroscopy --- sample with topiramate ethyl standard infrared spectra (see Figure 1), there should be no significant difference.
Liquid chromatography --- The identification test can be carried out simultaneously with the determination of topiramate ethyl mass fraction. Under the same chromatographic operating conditions,
Retention time with the standard solution of the sample solution to a peak of topiramate ethyl chromatographic retention time, the relative difference should be 1.5%
Fewer.
Figure 1 topiramate ethyl standard infrared spectra
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);
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 original drug topiramate ethyl liquid chromatography is shown in Figure 2.
1 --- topiramate ethyl.
2-ethyl pyridine liquid chromatogram of the original drug
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 the sample 0.05g (accurate to 0.0002g), placed in 100mL flask, add 80mL of methanol, in an ultrasonic bath
Sonication 5min. Remove cooled to room temperature, add methanol to volume, shake; pipette imbibe 10.00mL, placed in a
50mL volumetric flask, add methanol to volume, shake.
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)
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 1.2%, the arithmetic mean value as a measurement result.
4.4 Determination of loss on drying
4.4.1 Instruments and Appliances
Weighing bottle. diameter 50mm, height 20mm;
Oven. 100 ℃ ± 2 ℃;
Dryer.
4.4.2 Procedure
The weighing bottle placed in 100 ℃ ± 2 ℃ oven baking 1h, and then into the dryer to cool to room temperature, weighed (accurate to 0.0001g).
Repeat the above steps until constant weight weighing bottle. In weighing bottle was weighed into a 10g sample (paved weighed accurate to 0.0001g). Will be referred
Flask back into the oven and bake uncovered 1h, the lid is removed and placed in a dryer 0.5h cooled weighed (accurate to 0.0001g). repeat
The operation until the weighing bottle and the sample constant weight.
4.4.3 Calculation
2 samples of loss on drying (%) according to equation (2).
100 (2)
Where.
According to GB/T 1601 carried out.
4.6 Determination of dichloromethane insolubles
According to GB/T 19138 be taken to replace dichloromethane acetone.
4.7 product testing and acceptance
Product inspection and acceptance shall comply with GB/T 1604's. Treatment of extreme values, using the rounding value comparison method.
5 marking, labeling, packaging, storage and transportation
5.1 original drug topiramate ethyl shall comply with the provisions of GB 3796. Plastic pail or metal pail lined with plastic, watch the original drug topiramate ethyl clean application
You can not make direct contact with the metal. Net weight 50kg per barrel ships or 200kg.
5.2 is also available upon request or order agreement, the use of other forms of packaging, subject to the provisions of GB 3796.
5.3 topiramate ethyl original drug package should be stored in well-ventilated, dry coffers.
5.4 storage, prevent moisture and sunlight, no food, seed, feed mix, avoid contact with skin, eyes, mouth and nose to prevent inhalation.
5.5 Security. 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.
5.6 of acceptance. acceptance of the original drug topiramate ethyl for a month. From the date of delivery, product quality inspection completed within a month of its
Indicators should meet the standards.
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