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GB 22612-2008: [GB/T 22612-2008] Cartap hydrochloride technical
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[GB/T 22612-2008] Cartap hydrochloride technical
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GB 22612-2008
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Basic data | Standard ID | GB 22612-2008 (GB22612-2008) | | Description (Translated English) | [GB/T 22612-2008] Cartap hydrochloride technical | | Sector / Industry | National Standard | | Classification of Chinese Standard | G25 | | Classification of International Standard | 65.100.10 | | Word Count Estimation | 12,183 | | Date of Issue | 2008-12-17 | | Date of Implementation | 2009-06-01 | | Quoted Standard | GB/T 1600; GB/T 1601; GB/T 1604; GB/T 1605-2001; GB 3796 | | 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 requirements cartap original drug, test methods and marking, labeling, packaging, storage and transportation. This standard applies to Cartap impurities generated in the production and composition of Cartap original drug. | GB 22612-2008: [GB/T 22612-2008] Cartap hydrochloride 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.
Cartap hydrochloride technical
ICS 65.100.10
G25
National Standards of People's Republic of China
CARTAP original drug
Posted 2008-12-17
2009-06-01 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 is 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 (SAC/TC133) centralized.
This standard is drafted by. Shenyang Chemical Research Institute.
Participated in the drafting of this standard. Jiang Su Tianrong Group Co., Ltd., Qingdao Hailier Pharmaceutical Company Limited.
The main drafters of this standard. Meibao Gui, Xing Hong, Wang Qiang, Wen Shao.
CARTAP original drug
Other name, structural formula and basic physicochemical parameters of the active ingredient CARTAP product as follows.
Generic Name. CARTAP
ISO common name. Cartaphydrochloride
Chemical Name. 1,3-bis (carbamoylmethyl S) -2-dimethylamino-propane hydrochloride
Structure.
CH
CH
2SC
H2 N
N (CH3) 2 · HCl
CH
2SC
H2 N
Empirical formula. C7H16ClN3O2S2
Molecular Weight. 273.8 (according to 2007 international relative atomic mass)
Biological activity. Insecticidal
Melting point. 179 ℃ ~ 181 ℃ (decomposition)
Vapor pressure (25 ℃). small
Solubility (25 ℃). water for about 200g/L, slightly soluble in methanol, ethanol, insoluble in acetone, ether, ethyl acetate, chloroform, benzene, n
Hexane and other organic solvents
Stability. stable under acidic conditions, hydrolysis in neutral and alkaline media. Hygroscopic, non-corrosive
1 Scope
This standard specifies the CARTAP original drug requirements, test methods and marking, labeling, packaging, storage and transportation.
This standard applies to the CARTAP impurity generated in the production and composition CARTAP original drug.
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
3 Requirements
3.1 Appearance
White powder or white crystals.
3.2 Technical Specifications
CARTAP original drug should be consistent with the requirements in Table 1.
Table 1 CARTAP original drug control project indicators
Item Index
CARTAP mass fraction /% ≥ 97.0
Moisture content /% ≤ 1.0
Score a /% Water insoluble mass ≤ 0.2
pH range 3.0 to 6.0
When a normal production, the quality of water insoluble fraction 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. 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.
Infrared spectroscopy --- CARTAP sample and standard samples in the infrared 4000cm-1 ~ 400cm-1 absorption spectrum should be no significant difference.
CARTAP standard infrared spectrum is shown in Figure 1.
Figure 1 CARTAP standard infrared spectrum
HPLC --- The identification test can be carried out simultaneously with the determination of the mass fraction of CARTAP. In the same chromatographic operating conditions
, The sample solution to a chromatographic retention time and CARTAP CARTAP standard solution peak retention time, the relative difference should
1.5% or less.
Determination of the mass fraction of 4.3 CARTAP
4.3.1 Method summary
Phosphoric acid aqueous sample was dissolved in heptane solution of sodium + acetonitrile as mobile phase, to use as filler Capcel-PakC18 stainless steel
Column and UV detector (225nm), the sample of CARTAP reverse phase high performance liquid chromatography, external standard.
4.3.2 Reagents and solutions
Acetonitrile. HPLC grade;
Water. The new secondary steam distilled water;
Phosphoric acid;
Phosphoric acid. water with phosphoric acid adjusted to pH 2.5;
Geng sodium;
Triethylamine;
Heptane sulfonate solution. Weigh 3.64g of sodium heptanoate in 1L wide-mouth bottle, add distilled water 900mL secondary shaking to dissolve,
Phosphoric acid was added 16mL; then triethylamine adjusted to pH 2.0;
CARTAP standard. a known mass fraction ≥99.0%.
4.3.3 Instruments
High performance liquid chromatography. a variable wavelength UV detector;
Chromatographic data processor or chromatography workstation;
Column.200mm × 4.6mm (. I.d) stainless steel column, built Capcel-PakC18,5μm 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 (heptane solution of sodium. acetonitrile) = 90.10, 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. 225nm;
Injection volume. 10μL;
Retention time. 7.4min.
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 CARTAP original drug HPLC is shown in Figure 2.
1 --- CARTAP.
HPLC Figure 2 CARTAP original drug
4.3.5 measuring step
4.3.5.1 Preparation of standard solution
Weigh 0.05g (accurate to 0.0002g) CARTAP standard, a 50mL volumetric flask, dissolved in aqueous phosphoric acid and diluted to the mark
Degree, shake.
4.3.5.2 Preparation of sample solution
Weigh containing CARTAP 0.05g (accurate to 0.0002g) sample, placed in 50mL volumetric flask, and diluted with aqueous phosphoric acid
To the mark.
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 fenitrothion Danfeng area relative change
After less than 1.5%, according to the solution, sample solution, sample solution, standard order of 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 fenitrothion Danfeng area were averaged. Sample CARTAP
The mass fraction of 1 (%) according to equation (1).
1 = A2
(1)
Where.
A1 --- standard solution, fenitrothion mean Danfeng area;
A2 --- sample solution, fenitrothion mean Danfeng area;
--- CARTAP standard mass fraction, expressed as a percentage.
4.3.6 allowable difference
CARTAP 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 Moisture
According to GB/T 1600 in "azeotropic method".
4.5 Determination of insoluble matter
4.5.1 Reagents and Instruments
Conical flask. 250mL;
Glass sand core crucible. G3;
Oven. 105 ℃ ± 2 ℃;
Suction flask. 500mL.
4.5.2 Determination
Weigh 10g sample (accurate to 0.01g), into a conical flask, 100mL water, shaking the sample has been dissolved immediately by
Constant weight (accurate to 0.0002g) filter crucible, and then 60mL of water, washed three times Erlenmeyer flask filtration. The crucible was placed in an oven dried
2h, brought out in the dryer to cool and weigh (accurate to 0.0002g).
4.5.3 Calculation
Sample water insolubles 2 (%) according to equation (2).
(2)
Where.
4.5.4 allowable difference
Relative deviation parallel determination results shall be not more than 30% of the arithmetic mean as a measurement result.
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 and transportation
Flag 5.1 CARTAP original drug, labeling, packaging shall comply with the provisions of GB 3796.
5.2 CARTAP original drug application of clean, dry polypropylene pail, net weight per barrel 25kg.
5.3 Other forms of packaging may be used according to user requirements or the order agreement, it should comply with the provisions of GB 3796.
5.4 CARTAP original drug 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 Security. CARTAP moderately toxic pesticides. Are swallowed or inhaled poisoning. The FDA should wear protective gloves, gas masks, wear dry
Net protective clothing. After application, immediately wash with soap and water. In case of poisoning, please immediately sent to hospital for treatment.
5.7 Acceptance period. CARTAP original drug acceptance period of 1 month. From the date of delivery, the quality of the finished product acceptance within one month, the indicators
It shall meet the standards.
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