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热搜交联剂MDI催化剂促进剂
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  • Appearance Yellow amorphous powder Solubility Freely soluble in water, sparingly soluble in dimethylformamide, insoluble in ethanol(96 percent V/V) Identification A. Infrared absorption B. HPLC Appearance of solution Clarity ≤1# Color 80mg/ml, <BY3 or B4 Acidity or alkalinity 6.5~7.5 Composition and related substances Teicoplanin A2 group ≥80.0% Teicoplanin A2-2 35.0~55.0% Teicoplanin A2-1 group ≤20.0% Teicoplanin A2-3 group ≤20.0% Teicoplanin A2-4 ≤20.0% Teicoplanin A2-5 group ≤20.0% Teicoplanin A3 group ≤15.0% Total of impurities ≤5.0% Impurity A 0.2% max Residual solvents Ethanol ≤5000ppm Acetone ≤5000ppm Acetaldehyde ≤2000ppm Propionaldehyde ≤2000ppm Sodium chloride 5.0% max metals 20ppm max Water 15% max Sterility Conform Bacterial endotoxins <0.31 EU/mg Potency (dried substance) ≥900 IU/mg
  • Appearance White powder Identification Positive Specific rotation -11.0°~ -13.0° Assay 95.0~101.0% 1,2-Dihydroxyipopyiphosphonate ≤1.5% Alkalinity(PH) 8.1~9.6 Water 8.5~11.5 metals ≤20ppm Chloride ≤0.2%
  • Appearance White or almost white powder Identification Color reaction: The test solution obtain colorless, the blank solution abtion orange Color reaction: The solution obtain blue Sodium salt reaction: White precipitate generated Assay, on dry base 95%-101% PH 9.0-10.5 Specific optical rotation -5.5~-4.2˚ Water, K.F 1.0% max metals(ppm) 10ppm max Impurity A 1.0% max
  • Appearance A White Crystalline powder Assay,on dry base 98.5%-101.5% Solubility Soluble in methanol,insoluble in chloroform Melting point range 148.0 -156.0 ℃ Indentification A:Infrared Absorption B:The retention time of the major peak in HPLC C:The test for Oxalate A:The assay should accord with regulation B:The assay should accord with regulation C:It should meets the for Oxalate Loss on drying Not more than 1.0% metal Not more than 10ppm Residue on ignition Not more than 0.1% Specific Rotation +10.0~+14.0(in 0.05g/ml Methanol) R-isomer 1.0% max PH(in 0.01g/ml water) 2.0~4.0 Residual Sovents Terahydrofuram not more than 0.072% Toluene not more than 0.089% Any impurity peak Total impurities Any impurity peak: 0.1%max Total impurities: 0.5% max TLC Purity No secondary spot
  • Appearance Yellow crystalline powder Identification (1),(2),(3) should comply PH 2.0-3.0 Specific Absorbance 300~335 at 349nm Specific optical rotation -105°~ -120° Light absorbing impurities 0.07 max at 490nm Related substances (1)β-epidoxycycline ≤2.0% (2) melacycline ≤2.0% (3) Any other impurity ≤0.5% Ethanol 4.3-6.0% metals 50ppm max Sulphate ash 0.4% max Water 1.4~2.8% Assay 88.0-94.0% based on anhydrous ethanol-free substance
  • Appearance White or almost white crystalline powder Purity(HPLC) 99% min
  • Appearance White powder Identification Positive Loss on drying ≤5.0% Assay ≥98%
  • Appearance A white to off white powder Identification A. IR: Sample IR spectrum corresponds with that of the standard B. HPLC: The RT of the major peak of the Test solution corresponds to that of the Standard solution C: PXRD: Positive Loss on drying NMT 1.0% metals NMT 20ppm Sulphated ash NMT 0.1% Related substances α-Decitabine:≤0.15% Single unknown impuritie:≤0.1% Total impurities:≤1.0% Residual solvents DMSO:NMT 0.5% Methanol: NMT 0.3% Methyl formate: NMT 0.05% Acetonitrile: NMT 0.041% Methyl toluate: NMT 0.05% Assay(HPLC) 98.0-102.0%(On the dried basis)
  • Appearance White to off white powder Melting point 257 - 270℃ Specific optical rotation +137°~ +139° metal ≤20ppm Loss on drying ≤0.5% Solvent residue ≤0.5% Total impurity ≤1.0% Assay 99% min
  • Appearance White needle crystal Assay, HPLC 99%min Melting point 225-230℃ Solubility Soluble in DMSO, Slightly soluble in Ethanol Residue on Ignition 0.1% max Impurity A 0.5% max Impurity B 0.5% max Impurity C 0.15% max Impurity D 0.15% max metals 20ppm max Loss on drying 0.5% max
  • Appearance White Powder Assay 99% min. Solubility Water soluble Single impurity 0.2% max Loss on drying 0.5% max Storage Tightly closed, keep at Room Temp and dry
  • Appearance White or off-white powder Assay 86.3-100.7% Specific optical rotation +175~+190˚ Identification Should comply with USP35 PH 5.0-7.5 Water 1.0% max Related substance Piperacillin related compound A: 3.5% max Piperacillin related compound C:1.0% max Bacterial endotoxins 0.07 USP EU/mg of piperacillin max Sterility Should be sterile
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