Itraconazole Powder
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Description
Our organization has gained prominence for formulating Itraconazole that is a triazole antifungal agent recommended for treating fungal infections. These are helpful in reducing the fungal cytochrome P450 oxidase-mediated synthesis of ergosterol. Practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran and very slightly soluble in alcohol, Itraconazole - E.P. is available in the following specifications:
| 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-one |
| TEST | STANDARDS |
| Description | A white or almost white powder |
| Solubility | Practically 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,D |
| A) Melting range | Between 166.0°C and 170.0°C |
| B) IR absorption | The IR absorption spectrum of the sample should match with the spectrum of the Itraconazole working standard. |
| C) TLC | The principle spot in the chromatogram obtained with the test solution is similar in position, color and size to the principle spot in the chromatogram obtained with reference solution (a) and reference solution (b) shows two clearly separated spots. |
| D) Chlorides | White crude precipitate observed which is easily dissolved in excess of ammonia solution. |
| Clarity and appearance of solution | 10 w/v solution in Methylene chloride should be clear and not more intensely colored than reference solution BY6 |
| Optical rotation (10% in Methylene chloride) | -0.10°C to +0.10°C |
| Related substances (By HPLC) | Any single impurity : NMT 0.50% Total impurities : NMT 1.25% |
| Loss on drying (100 to 1050C for 4 hrs) | NMT 0.50% w/w |
| Sulphated ash | NMT 0.10% w/w |
| Assay (on dried basis) | NLT 98.5% and NMT 101.5% w/w |
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Itraconazole Powder
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