氟尼辛葡甲胺

Appearance

A white to almost white,crystalline powder

Solubility

Freely soluble in water and methanol, paractically insoluble in acetone

Identification 1

Infrared absorption: 197M; U ltraviolet absorption: 197U

Identification 2

Water:FREE SOLUBLE; 

Ethanol(96%):FREE SOLUBLE;

Ethyl acetate:PRACTICALLY INSOLUBLE

Appearance of solution

Clear and not more intensely coloured than reference solution Y7

Melting Point

137~140°C

pH

5%(W/V) water solution; 7.0~9.0

Related Substances

2-chloropyridine-3carboxylic acid ≤0.2%

2-methyl-3-(trifluoromethyl)aniline ≤0.2%

ethyl 2-chloropyridine-3-carboxylate ≤0.2%

ethyl 2-[[2-methyl-3-(trifluoromethyl)

phenyl]amino]pyridine-3-carboxylate ≤0.2%

Impurities

1.Single impurity ≤ 0.2%

2.Unknown impurity ≤ 0.2%

Total impurities(1~2) ≤ 0.5%

Specific optical rotation

-9.0º~ -12.0º

Solvent residue

Acetonitrile ≤ 0.041%

Methanol ≤ 0.3%

Ethanol ≤ 0.5%

Isopropanol ≤ 0.5%

Ethyl acetate ≤ 0.5%

Bacterial endotoxins

≤ 4.54 EU/mg

Water

≤0.5%

Sulphated Ash

≤0.1%

Residual Solvent

≤0.2%

colour of solution:

clear, less coloured than reference solution y6, b.p.(Vet)

clarification

1.2g funixin meglumine/8.8g water

Explanation

Micronisarion 200±20μm

Assay(On the anhydrous basis) It contains C14H11F3N2O2·C7H17NO5

99~101%