Process for preparation of grapiprant
The invention relates to process for the preparation of grapiprant and its intermediates thereof. The invention also relates to grapiprant having a purity 98% or more and compounds of Formula (A), (B), (C) and (D) in an amount of 0.5 or less, relative to grapiprant, by area percentage of HPLC. The invention also relates to an amorphous form of grapiprant and process for preparation thereof.
1. A composition comprising grapiprant having a purity of about 98% or more, and one or more compounds of Formula (A), (B), (C), and (D), in an amount of about 0.5% or less, relative to grapiprant, by area percentage of HPLC:
2. The composition according to claim 1 , wherein the grapiprant is in an amorphous form.
3. The composition according to claim 1 , wherein the composition further comprising one or more pharmaceutically acceptable carriers, excipients, and diluents.
4. The composition according to claim 1 , wherein the grapiprant is having particle size distributions, wherein the 10th volume percentile particle size (D10) is 50 μm or less, the 50th volume percentile particle size (D50) is 200 μm or less, or the 90th volume percentile particle size (D90) is 400 μm or less, or any combination thereof.