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1. Before enter the classroom, print the USP monograph & relevant General Chapters for Acetaminophen Oral Suspension and highlight all stability indicating tests and specifications 2 Marks

18 / 01 / 2019 Pharmacy

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In class assignment: Setting shelf-life period and expiry dates
Set an expiry date for Acetaminophen Oral suspension, given the following data:
Given: 
•    6 months Accelerated Studies data are within spec. for all attributes tested.
•    Long Term Stability data have been summarized, below.

1.    Before enter the classroom, print the USP monograph & relevant General Chapters for Acetaminophen Oral Suspension and highlight all stability indicating tests and specifications                                2 Marks
2.    Evaluate the Stability Summary Report (below) and circle all significant changes (e.g., spec. failures); you must calculate the Limit of 4-aminophenol (degradant impurity) in order to assess that data                        2 Marks
3.    Calculate the Limit of 4-aminophenol from the information given below                         1 Mark
4.    Propose a shelf life period (e.g., 6 mths, 1 yr, 2 yrs, 3 yrs); justify your duration, based on the ICH guidelines    4 Marks
5.    Propose a Product Expiry Date, given that the initial time point data was acquired on Nov. 22, 2013        1 Mark


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