Itraconazole

Details:

1 We offer Itraconazole 2 Our Quality is according to latest pharmacopeia                                                                                  Itraconazole DescriptionSpherical white to off-white pelletsIdentification by HPLCThe retention time of the itraconazole main peak in the HPLC chromatogram of the assay preparation shall corresponds to that of the Itraconazole main peak in the chromatogram of the standard preparation.Moisture content by KF(%w/w)NMT 2.0Bulk-density (gm/ml)0.70 to 0.85Dissolution in 0.1N hydrochloric acid(pH 1.20)(% w/w) NLT 85.0%  of Iraconazole should be dissolved in 60 minutes.Pellet sizeNLT 90% pellets should pass through 16 mesh & NMT 10% pellets should pass through 20 meshAssay(each gm of pellets contains itraconazole, % w/w)NLT 20.90% & NMT 23.10%A white or almost white powder PRODUCT NAME ITRACONAZOLE E.P.Chemical Name 2-butan-2-yl-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1,2,4-'triazol-1-yl methyl)-1,3-dioxolan-4-yl]methoxy] phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-oneTEST STANDARDSDescriptionA white or almost white powderSolubilityPractically insoluble in water, freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran and very slightly soluble in alcohol.Identification First Identification      (B) Second Identification A,C,DA) Melting rangeBetween 166.0°C and 170.0°CB) IR absorptionThe IR absorption spectrum of the sample should match with the spectrum of the Itraconazole working standard.C) TLCThe principle spot in the chromatWe offer Itraconazole pelletsOur Quality is according to latest pharmacopeia                                                                                  Itraconazole pelletsDescriptionSpherical white to off-white pelletsIdentification by HPLCThe retention time of the itraconazole main peak in the HPLC chromatogram of the assay preparation shall corresponds to that of the Itraconazole main peak in the chromatogram of the standard preparation.Moisture content by KF(%w/w)NMT 2.0Bulk-density (gm/ml)0.70 to 0.85Dissolution in 0.1N hydrochloric acid(pH 1.20)(% w/w) NLT 85.0%  of Iraconazole should be dissolved in 60 minutes.Pellet sizeNLT 90% pellets should pass through 16 mesh & NMT 10% pellets should pass through 20 meshAssay(each gm of pellets contains itraconazole, % w/w)NLT 20.90% & NMT 23.10%