S.

No Study
1.
Drug Excipient
compatibility Studies

Required Qty (Min)

10 spatulas

Justification
Minimum 10 based on Avg

Project wise Excipient : Total for all Projects: 114, Avg: 9.5 = 10
Deferasirox suspension : 9
Deferasirox Tablets : 10
Solifenacin ODTablets : 12
Linagliptin Tablets :7
Prasugrel Tablets : 9
Itopride SR Capsule : 9
2.

3.
4.

5.
6.

Paliperidone ER Tablets: 12
Sitagliptin Tablets : 7
Sitagliptin + Metformin IR Tablets: 8
Sitagliptin + Metformin ER Tablets :13
Linagliptin + Metformin IR Tablets :9
Rebamipide ER Tablets : 9

Routine weighing of
Disintegrants, Binders,
Colorants , Plasticizers
and Lubricants
LOD Checking of
Granules
Scrapping / Racking of
Powder in RMG
Blades / Sides after
Granulation / Dry Mix
Sampling of Powder
from Blender / Poly
Bag
Placebo Filling in Vials
/ HDPE Bottles

5 spatulas

Minimum 5 Spatula

1 spatulas

Minimum 1 Spatula

1 spatulas

Minimum 1 Spatula

1 spatulas

Minimum 1 Spatula

1 spatulas

Minimum 1 Spatula

Total

19 spatulas

19

Spatulas Required for FRD for Batch Processing