Aprepitant Powder
| Specifications (USP 39) | Tests | Row |
| White to off – white powder . Sparingly soluble in alcohol: slightly soluble in acetonitrile: practically insolublc in water |
Description And Solubility | 1 |
| A) IR Spectrum <197k> B) The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay |
Identification | 2 |
| NMT 0.5% | Water Content (By karl Fischer) | 3 |
| NMT 0.1% | Residue on ignition | 4 |
| (+66.0 to +71.0) | Specific Optical Rotation | 5 |
| Desfluoro aprepitant NMT 0.15% Any individual unspecfied impurity NMT 0.1% Total Impurity NMT 0.3% |
Organic Impurities | 6 |
| NMT 0.1% | Limit of S.R.S – Enantiomer | 7 |
| 98.0% – 102.0% | Assay (By HPLC) | 8 |
| Methanol NMT 3000 ppm Dimethyl Formamide NMT 880 ppm |
Residual Solvents | 9 |
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