Concept explainers
Active pharmaceutical ingredient. During the development of a new drug. pharmaceutical companies monitor the drug's active pharmaceutical ingredient (API). An article published in Organic Process Research & Development (July 2013) demonstrated the use of an individual control chart (x-chart) for this purpose. The data in the table represent API values for 53 consecutive batches of the new drug. (Note: Read across rows for consecutive API - measurements.) A Minitab printout with
- a. Locate the
mean and standard deviation of the sample data on the printout. - b. Use the mean and standard deviation to find the center line and the upper and lower control limits for an x-chart of the data, as in Example 13.3” (p. 13-15).
- c. Plot the data in an x-chart Is the process in control? No
Source: Based on K. Mukundam el al., “1-MR Control Chart: A Tool for Judging the Health of the Current Manufacturing Process of an API and for Setting the Trial Control Limits in Phase I of the Process Improvement.” Organic Procesa Research A Development. Vol. 17. July 2013 (Table 3).
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Statistics for Business and Economics (13th Edition)
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