Sr. No. | Test | Specification |
1 | Description | White to off White powder. Melt at about 220°C. |
2 | Solubility | Soluble in Acetone and in methylene chloride. |
3 | Identification By IR By HPLC |
The Infra-red absorption spectrum of sample is concordant with that of the standard The retention time of the sample solution corresponds to that of the standard solution, both relative to the internal standard as obtained in the assay. |
4 | Specific optical rotation | Between +56°C to +62°C |
5 | Loss on Drying | NMT 0.5 % |
6 | Residue on Ignition | NMT 0.1 % |
7 | Organic Impurities | No secondary spot from the sample solution should larger or more intense than the principal spot from standard solution C; and the sum of the intensities of the secondary spots from the sample solution is NMT 2.0 % |
7 | Assay by HPLC | NLT 97% and NMT 102.0% of Mometasone furoate C27H30CI2O6 (on Dried Basis) |