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2. 理化性质
2. PHY&CHEM
 
原药产品理化性质实验:
 
Sr. No.
 TYPE / NAME OF THE STUDY EPA, OPPTS OECD  EEC  Other  CIPAC 
1.
 Characterization of Active (Certificate of Analysis) 　 - - - -
2.
 Appearance- Physical state/Colour/Odour 830.6303 - - - -
3.
 Method Development and Validation (A.I. content) 830.18 - SANCO/303 0/99 rev4  - -
4.
 pH 830.7 - - - MT - 31/MT-75 
5.
 Acidity / Alkalinity 830.7 - - - MT - 31/MT-75 
6.
 Boiling point/Boiling range- Dynamic 830.722 103 A.2  - -
7.
 Spectra Analysis - - - - -
8.
 Corrosion characteristics 830.632 - - - -
9.
 Density / specific gravity 830.73 109 A.3  - MT - 3 
10.
 Flammability - Solid 830.6315 - A.10  - MT - 12 
11.
 Flash point 830.6315 - A.9  - MT - 12 
12.
 IR / FTIR spectra - - - - -
13.
 Melting point/Melting range/Freezing Temperature-Capillary Tube 830.72 102 A.1  - MT-1/MT-2 
14.
 Miscibility (hydrocarbon oil) 830.6319 - - - MT - 23 
15.
 Moisture content - - - - MT - 32 
16.
 MS spectra - - - - -
17.
 Oxidation / reduction 830.6314 - - - -
18.
 Oxidizing properties (Solid) - - A.17  - -
19.
 Partition coefficient (Octanol: water) - Shake flask method 830.755 107 A.8  - -
20.
 Partition coefficient (Octanol: water) - HPLC 830.757 117 A.8  - -
21.
 Auto Flammability - - A.15  - -
22.
 Auto self ignition (Solid) 　 　 A.16  - -
23.
 Shelf life (storage stability)- One year/2-year/5-year/Cold Temp. 830.6317 - - - -
24.
 Solvent solubility (for each solvent) 830.784 105 A.6  - -
25.
 Storage Stability- Heat stability (54 ± 2°C) 830.6317 - - - MT - 46 
26.
 Storage Stability- With metal and metal iron at normal and elevated temperature 830.6313 - - - -
27.
 Storage Stability- Thermal and Air stability - 113 - - -
28.
 Surface tension (Liquids / Solid) - 115 A.5  - 　
29.
 UV/Vis absorption 830.705 101 　 - 　
30.
 Vapour Pressure 830.795 104 A.4  - -
31.
 Viscosity of liquids 830.71 114 - - MT - 22 
32.
 Water solubility (3 pH) 830.784 105 A.6  - -
33.
 -Explodability (For Solids) 830.6316 - - - -
34.
 -Corrosiveness - - - ASTM G­31-72  -
 
制剂产品理化性质实验:
 
Sr. No.
 TYPE / NAME OF THE STUDY EPA, OPPTS OECD  EEC  Other  CIPAC 
1.
 Dry sieve test / particle size distribution - - - - MT 58.2/59.1/170 
2.
 Dispersive characteristics - - - - MT 180/36.1 
3.
 Foam Persistent - - - - MT 47.2 
4.
 Low Temprature Stability - - - - MT 39.1 
5.
 Pourability - - - - MT 148 
6.
 Wet Sieve Test - - - - MT 59.3 
7.
 Dilusion stability - - - - MT 41 
8.
 Dust Content - - - - MT 171 
9.
 Flowability - - - - MT 172 
10.
 Friability and Attrition - - - - MT 178 
11.
 Degree of Dispersion (Dispersibility) - - - - MT 174 
12.
 Wettability - - - - MT 53.3 MT 15, MT 161, 
13.
 Suspensibility - - - - MT 168, MT 177and MT 184 
14.
 Emulsification/Re-emulsification - - - - MT 20, MT 36.1.1 and MT 173 
15.
 Spontaneity of Dispersion - - - - MT 160 
16.
 Nitrosoamine (Using TEA Detector) 　 　 　 　 　
 
 
 
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