Description White or almost white crystalline powder Identification Conform Acidity(PH) 5.5-7.5 Specific Optical Rotation +285^-+310^ Absorbance: 264nm 0.80~0.88 280nm ≤0.10 325nm ≤0.10 Related Substance ≤1% 2-Ethylhexanoic Acid ≤0.5% Loss on Drying ≤1.0% Sterility Conform Bacterial Endotoxins ＜0.16IU/mg Assay(As dry substances) 96.0%-102.0% Potency(As dry substances) --

Appearance White powder Assay 97.0-103.0% Water ≤0.5% Identification POSITIVE Residue on ignition ≤0.30% Oraganic volatile impurities ≤0.03% Particle Size 90%＜12um 10%btn 12～25um

Appearance White or almost white crystalline powder Identification (1),(2),(3) Appearance of solution 5# max Clear 1# max PH 8.0-10.0 Specific optical rotation +258˚ ~+287˚ Residual Solvents Comply with standard Related substance Comply with standard 2-ethylhexanoate 0.8% max Water 2.0% max Bacterial endotoxins 0.1IU/mg max Sterility Confirm Assay(on dry base) 85% min

Appearance White or almost white crystalline powder Identification (IR,HPLC) Complies with the Standard Specific optical Rotation +79.0°～+86.0° Related Substances Single impurity ≤0.5% Total impurities ≤2.0% Loss on drying ≤0.5% Assay(UV, basis on drying) 97.0~103.0%

Identification 1.A deep blue color is produced. 2.positive reaction Loss on drying Not more than 8.0% Residue on ignition Not more than 0.025% Iodine ion Not more than 6.6% metals Not more than 0.002% Nitrogen Not less than 9.5% and not more than 11.5%（ON the dried basis) Assay Povidone-Iodine contains not less than 9.0 percent and not more than 12.0 percent of iodine(I),calculated on the dried basis.

The appearance of the product A white to yellowish white powder PH（5% in water） 3.0~7.0 Water ≤5.0% Sulfated Ash ≤0.1% Metals（as Lead） ≤10PPM Acetaldehyde ≤0.05% Hydrazine ≤1PP N-Vinylpynrrolidinone ≤10PPM K-value 27-32 Nitrogen content 11.5~12.8% H2O2 ≤400PPM

Appearance White or almost white crystalline powder Assay 97-103% Melting point 155~161℃ Identification Infrared absorption absorption Specific rotation +171°~ +179° Loss on drying 0.5% max Related substances Total impurity: 2.0% max Individual impurity: 0.5% max

Pramipexole 104632-26-0 普拉克索 C10H17N3S 99%min 灰白色粉末

Characters - Appearance - Solubility A White or almost white powder , slightly hygroscopic, Freely soluble in water,very slightly soluble in ethanol (96% ) Identification A.Infrared absorption spectrophotometry B.Give reaction (a) of chlorides Appearance of Solution The solution is clear The solution is colorless PH 3.8 ∽5.6 Specific Optical Rotation +15 °∽+21 ° Water 16.0%∽20.0% Sulfated Ash Maximum 1.0% Related Substances: Maximum 1.0% Assay(based on anhydrous substance, by GC ) 95.0% ∽100.5% of C14H24N2O7 .2HCL Assay(based on hydrous substance, by GC ) ------ Potency ( based on hydrous substance , by GC) ------

Appearance White or yellowish-white powder Solubility Very slightly soluble in water, slightly soluble in alcohol. •Identification A: Melting point B: Specific absorbance C: IR-spectrum D: Chemical reaction 199-203℃ Max.287nm: 240-250 Complies with reference spectrum Green fluorescence at 365nm Appearance of solution Not more intensely colored than Reference Solution BY7 Related substances Method A by HPLC Impurity F≤0.1% Any single impurity≤0.1% Total impurities≤0.2% Method B by HPLC Any single impurity≤0.1% Total impurities≤0.2% metals ≤20ppm Residual methanol ≤3000ppm Residual DMSO ≤5000ppm Residual acetic acid ≤5000ppm Impurity K(aniline) by GC ≤5ppm Loss on drying ≤1.0% Sulphated ash ≤0.1% Assay 98.5-101.0%

Appearance A white or almost white hygroscopic powder Solubility Freely soluble in water, slightly soluble in ethanol(96%),practally insoluble in acetone trichlormathane or diethyl ether Identification Confirms to EP7.0 specification Acidity or alkalinity 4.0-6.0 Specific optical rotation -63º～-73º Related Total impurities ≤23.0% Any impurity ≤4.0% Impurity 1 ≤3.0% Impurity 2 ≤4.0% Impurity 3 ≤3.0% Impurity 4 ≤3.0% Impurity 5 ≤3.0% Impurity 6 ≤4.0 Sulphate 16%-18% Loss on drying 3.5% max Sulphated ash 1.0% max Assay(Dry Basis HPLC) Sum assay: 77%min E3: 10%max E1-I: 10%max E1-7MOA: 10%max Potency(Moisture bases) ---- Potency(dried bases) ≥19000u/mg

famotidine 76824-35-6 法莫替丁 C8H15N7O2S3 CP2010 USP31 JP15 White powder