SOP

Step 1:

Sieve all the materials and ingredients through sieve no. 16

Step 2:

Mix obeticholic acid lactose, Avicel 102(Half Qty), Primogel (Half Qty) in ribbon mixer for 15
to 30minutes.

Step 3:

Make a paste of starch and water

Step 4:

Add the paste and wet the mixed ingredients at step No. 2 and mix it for 15minutes

Step 5:

Following step 4, pass the wet mass through sieve no. 06 and dry it in tray oven at 60°C for
about 30 to 45minutes. LOD must be 20.0% to 2.5%

Step 6:

Mix remaining quanity of primogel and Avicel 102 with Aerosil in cube mixer

Step 7:

Now add Magesium stearate and mix for 5 minutes