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CHEM 370

Spring 2022 Project: Acetaminophen Quality Control

Memorandum

Western Analytics, Inc.
To: Pharmaceutical Division
From: Al Fischer, PhD
Subject: Acetaminophen Analysis

Western Analysts:

A confidential manufacturer of pharmaceuticals has encountered a manufacturing error in which their products were mixed up during manufacturing. They believe products marketed as chewable pain and fever relief (acetaminophen) may have been mixed up with the other products they make. The other products in question are (1) daytime headache relief (acetaminophen + aspirin + caffeine), (2) nightime headache relieve (ibuprofen + diphenhydramine), and (3) allergy relief eye drops (which contain mercury). We have been given samples of each suspect lot for analysis. All samples are supposed to contain 360 mg/g acetaminophen with flavoring added, and no other active ingredients.

Your job is to:

  1. Screen the products for contamination using the hit quality index method in Rodriguez et al 2011. You may also be able to use this method to verify that the samples match a specific type of product.
  2. Verify the acetaminophen concentration using HPLC. You may also see additional evidence of contamination in your chromatograms.
  3. Verify the flavorants added using GC-MS.
  4. Quantify mercury content using a flow-injection mercury system (FIMS).

Please turn in a technical report detailing the findings of your analyses. Your report should link together the results from all your analyses, use complementary results to bolster each other, and discuss what effects (if any) the findings from each analysis are likely to have on human health.

Record Keeping:

Due to the high-impact nature of this work, you must diligently keep track of all sample information – especially lot numbers – and data. You must also follow our standard quality-control and data-validation practices to ensure your results are accurate. Likewise, all results must meet the precision guidelines described in the procedure for each instrument.

Keep in mind:

  • There are no additional samples available – plan ahead to make sure you don’t use up all your sample!
  • The identity of each sample (provided on the bag/vial) must be explicitly tracked in your lab notebook and final report.
  • You must turn in a copy of your lab notebook each day you work in lab.
  • You must provide me with your final data files and lab notebooks (in addition to your report) for validation.
  • You must get trained on each instrument prior to using it.

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