This paper circulates around the core theme of 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 together with its essential aspects. It has been reviewed and purchased by the majority of students thus, this paper is rated 4.8 out of 5 points by the students. In addition to this, the price of this paper commences from £ 48. To get this paper written from the scratch, order this assignment now. 100% confidential, 100% plagiarism-free.
In class assignment: Setting shelf-life period and expiry dates
Set an expiry date for Acetaminophen Oral suspension, given the following data:
• 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