Answers

STABILITY COMPUTATION

Formulation:
Active 1: 65 mg (limits 95-105%)
Active 2: 15 mg (limits 90-110%)
Active 3: 122 mg (limits 90-110%)

Results of Analysis:




Questions:
1. Determine the minimum and maximum limits of each active based on the specifications:

• Active 1 = 61.75mg - 68.25mg
• Active 2 = 13.50mg - 16.50mg
• Active 3 = 109.80mg - 134.20mg

2. What is the shelf-life of the formulation?
A) 24mos
B) 12 mos
C) 36 mos
D) 48 mos
E) 6 mos

3. What would be the expiry date of a product manufactured on October 30, 2012?
A) October 30, 2013
B) October 30, 2014
C) October 30, 2015
D) October 30, 2016
E) October 30, 2017