med 18

 

3. In vivo bioequivalence documentation None

30 Industrial Pharmacy II

ii. Changes in the excipients as per the following per cent ranges (based on

assumption that the drug substance in the formulation is 100% of as mentioned

on label/potency and the total additive change should not be more than 10%)

are given in Table 3.3.

Table 3.3: Change in excipients (in %) as per SUPAC guidelines level 2

Name of excipients Percentage excipient of total target dosage form

weight (± n%)

Filler 10

Disintegrant

Starch 6

Other 2

Binder 1

Lubricant

Calcium or magnesium stearate 0.5

Other 2

Glidant

Talc 2

Other 0.2

Film coat 2

Test documentation (Table 3.4)

Table 3.4: Test documentation required as per SUPAC guidelines level 2

Sr. no. Type of test documentation Content

1. Chemistry documentation Application/compendial release requirements, batch

records and stability testing.

2. Dissolution documentation Case A: High permeability, high solubility drugs if

dissolution of 85% in 15 minutes in 900 mL of 0.1 N HCl.