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GB 22613-2008: [GB/T 22613-2008] Cartap hydrochloride water soluble powders
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[GB/T 22613-2008] Cartap hydrochloride water soluble powders
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GB 22613-2008
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Basic data | Standard ID | GB 22613-2008 (GB22613-2008) | | Description (Translated English) | [GB/T 22613-2008] Cartap hydrochloride water soluble powders | | Sector / Industry | National Standard | | Classification of Chinese Standard | G25 | | Classification of International Standard | 65.100.10 | | Word Count Estimation | 8,842 | | Date of Issue | 2008-12-17 | | Date of Implementation | 2009-06-01 | | 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 soluble powders, test methods and marking, labeling, packaging, storage and transportation. This standard applies to cartap original drug, suitable additives and fillers Cartap processed into soluble powder. | GB 22613-2008: [GB/T 22613-2008] Cartap hydrochloride water soluble powders---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 water soluble powders
ICS 65.100.10
G25
National Standards of People's Republic of China
CARTAP soluble powders
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, Lixue Chen.
CARTAP soluble powders
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.
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, more sensitive to moisture, non-corrosive
1 Scope
This standard specifies the CARTAP soluble powders requirements, test methods and marking, labeling, packaging, storage and transportation.
This standard applies to the original drug CARTAP, CARTAP soluble powders suitable additives and fillers processed into.
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 1603 Determination of emulsion stability of pesticide
GB/T 1604 Goods pesticide regulations for acceptance
GB/T 1605-2001 Sampling Method commercial pesticides
GB 3796 pesticide packaging General
GB/T 19136 Determination of Pesticide Thermal storage stability
3 Requirements
3.1 Composition and appearance
This product should be compliant CARTAP original drug is made, the appearance of a homogeneous loose powder, without clumps.
3.2 CARTAP soluble powders should meet the requirements of Table 1.
Table 1 CARTAP soluble powders Control Project Index
project
index
50% 95%
CARTAP mass fraction /% 50.0 + 95.0 + 2.5-2.5 2.5-2.5
Moisture content /% ≤ 3.0 1.5
Score a /% Water insoluble mass ≤ 0.6
pH range 3.0 to 6.0
The degree of dissolution and solution stability (through 75μm sieve)
a /%
(5min after residue) ≤
(18h after residue) ≤
1.0
0.05
Thermal storage stability test a qualified
a normal production of water insoluble matter, the degree of dissolution and solution stability, thermal 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. Determined by sampling a random number table method packages, 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 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 should be relative difference
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 soluble powders HPLC is shown in Figure 1.
1 --- CARTAP.
Figure 1 CARTAP soluble powders by high performance liquid chromatogram
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 =
(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 relative deviation of the mass fraction of two parallel determination results shall not be greater than 1.5%, 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 =
(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 degree of dissolution and solution stability
4.7.1 Method summary
The sample was dissolved in dissolution degree is 25 ℃ standard hard water, invert 15 times, standing 5min, filtered through a 75μm test sieve, quantitative measurement
Given the sieve residue. The solution stability is the solution to stand after 18h, again using the test sieve, sieve residue quantitatively determined.
4.7.2 Instruments
Standard sieve. aperture 75μm, diameter 76mm;
Stoppered cylinder. between 250mL (0mL ~ 250mL scale distance 20cm ~ 21.5cm, 250mL graduated from the line and the bottom plug
From a 4cm ~ 6cm).
Standard hard water. 342mg/L, prepared according to GB/T 1603 in the appropriate method.
4.7.3 Preparation of sample solution
In the graduated cylinder was added 250mL 2/3 standard hard water, its temperature was adjusted to 25 ℃, 5g of the sample, a standard hard water added to the mark.
Stoppered. Standing 30s, inverted measuring cylinder 15 times by hand, is reset. Reversed, once used by the reset time should not exceed 2s.
The sample solution was allowed to stand in the cylinder after 5min ± 30s, on into the constant weight 75μm sieve, and the filtrate was collected 500mL burn
Cup, reserved for the next test. 20mL graduated cylinder with distilled water five times, all insolubles were quantitatively transferred to a sieve, discard the washing liquid,
Check the sieve residue. If there is residue on the sieve, sieve 60 ℃ dried to constant weight, weighed in.
The filtrate was allowed to stand 18h, carefully observe whether the precipitation filtrate in the beaker. If there are insoluble materials, and then the sample was constant weight
75μm test sieve, sieve test with 20mL of distilled water 5 times, if there is the presence of crystalline solids or sieve, sieve dry at 60 ℃
Drying to constant weight and weighed.
4.7.6 Calculation
5min after the residue 3 (%) according to equation (3) Calculated.
3 =
(3)
Where.
18h after residue 4 (%) according to equation (4) Calculated.
4 =
(4)
Where.
4.8 Thermal storage stability test
According to GB/T 19136 "other agents" to. After the heat storage CARTAP content should not be less than the mass fraction of the reservoir before CARTAP
97%.
4.9 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
5.1 CARTAP soluble powder marking, labeling and packaging should comply with the provisions of GB 3796.
5.2 CARTAP soluble powders applied to clean, dry, lined with plastic bags or aluminum foil bag. Bulk bag net content
25kg. Small Package net weight 60g, 50g. You can also use other forms of packaging according to user requirements or the order agreement, subject to
The provisions of GB 3796.
5.3 CARTAP soluble powder packaging 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. 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.
5.6 Warranty. under the specified storage conditions, warranties of CARTAP soluble powders, from date of manufacture for 2 years.
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