Mometasone Furoate USP

Specification Mometasone Furoate

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

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)