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1、與農(nóng)藥劑型相關(guān)的控制項目原藥technical material (TC)母藥 technical concentrate (TK)Declared content in g/kg or g/l at 20 2CToleranceup to 2515% of the declared content for “homogeneous” formulations (EC, SC, SL, etc.), or25% for “heterogeneous” formulations (GR, WG, etc.)above 25 up to 10010% of the declared content
2、above 100 up to 250 6% of the declared contentabove 250 up to 500 5% of the declared contentabove 500 up to 90025 g/kg or g/labove 900 up to 1000the minimum content, only, is declared.Note In each range the upper limit is included1. 粉劑(DP) DUSTABLE POWDERS1)水分含量 Water (MT 30.5)Maximum: . g/kg.2)細(xì)度(通
3、過75m試驗篩)Dry sieve test (MT 59.1)Maximum: 5% retained on a 75 m test sieve.3)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .4)其他 Stability at elevated temperature
4、(MT 46.3)2. 乳油(EC) Emulsifiable concentrates1)水分含量Water (MT 30.5) Maximum: . g/kg.2)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .3)乳液穩(wěn)定性 Emulsion stability and
5、re-emulsification (MT 36.1.1, MT 36.3 or MT 183)Time after dilutionLimits of stability, MT 36.1, MT 36.30 hInitial emulsification complete0.5 hCream, maximum: . ml2.0 hCream, maximum: . mlFree oil, maximum: . ml24 hRe-emulsification complete24.5 hCream, maximum: . mlFree oil, maximum: . mlNote: in a
6、pplying MT 36.1 or 36.3, tests after 24 h are required only where results at 2 h are in doubtTime after dilutionLimits of stability, MT 1832 minAC reading maximum .7 to 32 minAC reading similar to above (no major increase, decline or fluctuation)Note: in applying MT 183, initial AC reading will be 1
7、 in most cases4)其他 Persistent foam (MT 47.2) (Note 7)Maximum: . ml after 1 min.Storage stabilityStability at 0C (MT 39.3)After storage at 0 2C for 7 days, the volume of solid and/or liquid which separates shall not be more than 0.3 ml.Stability at elevated temperature (MT 46.3)After storage at 54 2C
8、 for 14 days, the determined average active ingredient content must not be lower than .% relative to the determined average content found before storageand the formulation shall continue to comply with the clauses for:- acidity, alkalinity, pH range ,- emulsion stability and re-emulsification3. 可濕性粉
9、劑(WP) WETTABLE POWDERS1)水分含量 Water (MT 30.5)Maximum: . g/kg.2)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .3)懸浮率 Suspensibility (MT 15.1, MT 177, MT 184) (Notes
10、 5 & 6)A minimum of .% of the . ISO common name content shall be in suspension after 30 min in CIPACStandard Water D at 30 2C.4)濕潤時間 Wettability (MT 53.3)The formulation shall be completely wetted in . min without swirling.5)細(xì)度(通過45m試驗篩) Wet sieve test (MT 185)Maximum: .% retained on a 45 m test sie
11、ve.6)其他 Stability at elevated temperature (MT 46.3)After storage at 54 2C for 14 days, the determined average active ingredient content must not be lower than .% relative to the determined average content found before storageand the formulation shall continue to comply with the clauses for:- acidity
12、/alkalinity/pH range ,- wet sieve test ,- suspensibility ,- wettability ,Persistent foam (MT 47.2)Maximum: . ml after 1 min.4. 顆粒劑(GR) Granules1)水分含量2)松密度和堆密度(視需要)3)酸堿度(以H2SO4或NaOH計)或pH范圍4)粒度范圍5)脫落率或強度6)其他5. 懸浮劑(SC) Aqueous suspension concentrates1)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (M
13、T 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .2)濕篩試驗(通過75m試驗篩) Wet sieve test (MT 185) Maximum: .% of the formulation shall be retained on a . m test sieve.3)懸浮率 Suspensibility (MT 184)A minimum of .% of the . IS
14、O common name contentshall be in suspension after 30 min in CIPAC Standard Water D at 30 2C.4)傾倒性 Pourability (MT 148.1)Maximum residue: .%.5)持久起泡性 Persistent foam (MT 47.2) (Note 9)Maximum: . ml after 1 min.*Spontaneity of dispersion (MT 160)A minimum of .% of the . ISO common name contentshall be
15、in suspension after 5 min in CIPAC Standard Water D at 30 2C*Particle size distribution (MT 187)% of particles shall be in the range to *Viscosity (MT 192)The viscosity shall be in the range to .6)其他 Storage stabilityStability at 0C (MT 39.3)After storage at 0 2C for 7 days, the formulation shall co
16、ntinue to comply with clauses for:- suspensibility,- wet sieve test,Stability at elevated temperature (MT 46.3)After storage at 54 2C for 14 days (Note 11), the determined average active ingredient content must not be lower than .% relative to the determined average content found before storageand t
17、he formulation shall continue to comply with the clauses for:- acidity/alkalinity/pH range ,- pourability ,- spontaneity of dispersion ,- suspensibility,- wet sieve test ,6. 水劑(AS) aqueous solution1)水不溶物含量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)稀釋穩(wěn)定性4)其他7. 可溶粉劑(SP) Water soluble powders1)水分含量Water (MT 30.5)Maximu
18、m: . g/kg.2)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .3)溶解程度和溶液穩(wěn)定性(通過75 m試驗篩) Degree of dissolution and solution stability (MT 179)Residue of formulation ret
19、ained on a 75 m test sieve after dissolution in CIPAC Standard Water D at 30 2C :Maximum: .% after 5 min.Maximum: .% after 18 hours.4)濕篩試驗?5)潤濕時間 Wettability (MT 53.3)The formulation shall be completely wetted in . min without swirling.6)持久起泡性 Persistent foam (MT 47.2)maximum: . ml after . minIn the
20、 case of water soluble bag packaging, the provisions of clause 6.21.6.4 should be applied.7)其他 Stability at elevated temperature (MT 46.3)After storage 54 2C for 14 days, the determined average active ingredient content must not be lower than .% relative to the determined average content found befor
21、e storageand the formulation shall continue to comply with the clauses for:- acidity/alkalinity/pH range ,- wettability ,- degree of dissolution and solution stability ,8. 可溶粒劑(SG) Water soluble granules1)水分含量 Water (MT 30.5) Maximum: . g/kg.2)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191
22、) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .3)持久起泡性 Persistent foam (MT 47.2)If required, maximum . ml after 1 min.In the case of water soluble bag packaging, the provisions of clause 6.23.6.4 should be applied.4)溶解
23、程度和溶液穩(wěn)定性(通過75m試驗篩) 5)濕篩試驗 Degree of dissolution and solution stability (MT 179)Residue of formulation retained on a . m test sieve after dissolution in CIPAC Standard Water D at 30 2C .Maximum: . % after 5 min.Maximum: . % after 18 hours.*Dustiness (MT 171)Essentially non-dusty*Attrition resistance
24、(MT 178.2)Minimum: .% attrition resistance.*Flowability (MT 172)At least .% of the formulation shall pass through a 5 mm test sieve after 20 drops of the sieve.6)其他 Stability at elevated temperatures (MT 46.3)After storage at 54 2C for 14 daysthe determined average active ingredient content shall no
25、t be lower than .% relative to the determined average content found before storageand the formulation shall continue to comply with the clauses for:- acidity/alkalinity/pH range ,- degree of dissolution and solution stability ,- dustiness ,- attrition resistance ,9. 可溶片劑(ST) Water soluble tablets (1
26、)水分含量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)持久起泡性4)崩解時間5)溶解程度和溶液穩(wěn)定性(通過75 m試驗篩)6)濕篩試驗7)粉末和碎片8)其他10. 油劑(OL) Oil miscible liquids1)水分含量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)其他11. 超低容量液劑(UL) Ultra low volume liquids1)水分含量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)揮發(fā)性4)動力粘度5)其他12. 煙片(FT) smoke tablet1)水分含量或干燥減量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)成煙率4)自燃溫度
27、5)燃燒發(fā)煙時間6)跌落破碎率7)粉末和碎片8)點燃試驗9)其他13. 煙劑(FU) smoke generator1)水分含量或干燥減量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)成煙率4)自燃溫度5)點燃試驗6)燃燒發(fā)煙時間7)其他14. 煙粉粒劑(FU)1)水分含量或干燥減量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)成煙率4)干篩實驗5)自燃溫度6)點燃試驗7)燃燒發(fā)煙時間8)其他15. 水乳劑(EW) Emulsions, oil in water1)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) o
28、r pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated as NaOH.pH range: . to .2)乳液穩(wěn)定性 Emulsion stability and re-emulsification (MT 36.1.1, MT 36.3 or MT 183)The formulation, when diluted at 30 2Cwith CIPAC Standard Waters A and D, shall comply with the
29、 following:參EC3)傾倒性 Pourability (MT 148.1)Maximum residue: . %.4)持久起泡性 Persistent foam (MT 47.2)Maximum: . ml after 1 min.5)其他 Storage stabilityStability at 0C (MT 39.3)After storage at 0 2C for 7 days, no separation of particulate or oily matter shall be visible after gentle agitation.Stability at
30、elevated temperature (MT 46.3)After storage 54 2C for 14 days, the determined average active ingredient content must not be lower than .% relative to the determined average content found before storageand the formulation shall continue to comply with the clauses for:- acidity/alkalinity/pH range ,-
31、emulsion stability and re-emulsification ,16. 微乳劑(ME) Micro-emulsions1)酸堿度(以H2SO4或NaOH計)或pH范圍2)乳液穩(wěn)定性3)透明溫度范圍4)持久起泡性5)其他17. 懸乳劑(SE) Aqueous suspo-emulsions1)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: .
32、 g/kg calculated as NaOH.pH range: . to .2)濕篩試驗(通過45m試驗篩) Wet sieve test (MT 185)Maximum: . g/kg of the formulation shall be retained on a .m test sieve, at the dilutions specified.3)分散穩(wěn)定性 Dispersion stability (MT 180)The formulation, when diluted at 30 2Cwith CIPAC Standard Waters A and D, shall co
33、ntinue to comply with the following:Time after allowing the dispersion to standLimits of stability0 hInitial dispersion complete0.5 hcream, maximum: . mlfree oil, maximum: . mlsediment, maximum: . ml24 hRe-dispersion complete24.5 hcream, maximum: . mlfree oil, maximum: . mlsediment, maximum: . ml4)傾
34、倒性 Pourability (MT 148.1)Maximum residue: .%.5)持久起泡性 Persistent foam (MT 47.2)Maximum .ml after 1 min.*Particle size distribution (MT 187),% of particles shall be in the range to * Viscosity (MT 192), The viscosity shall be in the range to .6)其他 Storage stabilityStability at 0C (MT 39.3)After storag
35、e at 0 2C for 7 days, the formulation shall continue to comply with the clauses for:- acidity/alkalinity/pH range ,- dispersion stability ,- wet sieve test ,Stability at elevated temperature (MT 46.3)After storage at 54 2C for 14 days , the determined average active ingredient content must not be lo
36、wer than .% relative to the determined average content found before storageand the formulation shall continue to comply with the clauses for:- acidity/alkalinity/pH range ,- pourability ,- dispersion stability ,- wet sieve test ,18. 微囊懸浮劑(CS) Aqueous capsule suspensions1)總有效成分含量2)游離的有效成分含量或比值3)酸堿度(以
37、H2SO4或NaOH計)或pH范圍4)篩析(通過75m篩)5)懸浮率6)分散穩(wěn)定性7)傾倒性8)持久起泡性9)其他19. 水分散粒劑(WG) Water dispersible granules1)水分含量 Water (MT 30.5) Maximum: . g/kg.2)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalinity (MT 191) or pH range (MT 75.3)Maximum acidity: . g/kg calculated as H2SO4.Maximum alkalinity: . g/kg calculated a
38、s NaOH.pH range: . to .3)懸浮率 Suspensibility (MT 168, MT 184)A minimum of .% shall be in suspension after 30 min in CIPAC Standard Water D at 30 2C.In the case of water soluble bag packaging, the requirements of clause 6.13.6.3 should be applied.4)濕篩試驗(通過75m試驗篩)Wet sieve test (MT 185)Maximum: .% reta
39、ined on a 75 m test sieve.5)分散性 Degree of dispersion (MT 174)Dispersibility: minimum .% after 1 minute of stirring.6)濕潤時間 Wettability (MT 53.3)The formulation shall be completely wetted in . min.7)持久起泡性 Persistent foam (MT 47.2)Maximum: . ml after 1 minute.8)粒度范圍 Flowability (MT 172)At least .% of t
40、he formulation shall pass through a 5 mm test sieve after 20 drops of the sieve.*Dustiness (MT 171)Essentially non-dusty.*Attrition resistance (MT 178.2)Minimum: .% attrition resistance.9)其他Stability at elevated temperature (MT 46.3)After storage at 54 2C for 14 days, the determined average active i
41、ngredient content must not be lower that .% relative to the determined average content found before storageand the formulation shall continue to comply with the clauses for:- by-products of manufacture or storage ,- acidity/alkalinity/pH range ,- wet sieve test ,- degree of dispersion - suspensibility - dustiness - attrition resistance ,20. 可分散片劑(WT) Water dispersible tablets1)水分含量2)酸堿度(以H2SO4或NaOH計)或pH范圍3)崩解時間4)懸浮率5)濕篩試驗6)持久起泡性7)粉末和碎片8)其他21. 可溶液劑(SL) Soluble concentrates1)水分含量 Water (MT 30.5) Maximum: . g/kg.2)酸堿度(以H2SO4或NaOH計)或pH范圍 Acidity and/or Alkalin
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