Vial Requirement and test wise calculation

Vial Requirement

1. Sr. No. Particular No. of Vials 1 Photostabiity studies 696 2 Retention samples 1305 3 Stability study 1897 4 Nitrosamine 20 5 Elemental impurities 30 6 Dilution studies 40 7 Bulk Hold 120 8 Hopper challenge study 300 9 Speed challenge study 300 10 In use studies 150 11 Overfill 100 12 Q1/Q2 100   Total 5058