PHC533 - Pharmaceutical Calculations

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Last revision date Jan 4, 2021 9:10:56 PM
Last review date Jan 4, 2021 9:10:56 PM

Subject Title
Pharmaceutical Calculations

Subject Description
This subject covers the use and application of mathematical calculations used most specifically in chemical laboratories in the pharmaceutical industry. The equations that are outlined in the USP and other regulatory publications will be examined using case studies and provided data.

Credit Status
One credit toward the Chemical Laboratory (Pharmaceutical) Diploma

Learning Outcomes
Upon successful completion of this subject the student will be able to:

Upon successful completion of this subject the student will be able to do the following =>
Understand United States Pharmacopeia (USP) methods and techniques through judiciously selected pharmaceutical calculations done on the following topics:

  1. USP Karl Fischer (KF) titration methods (USPNF <921>)
  • Chemistry
  • Methodology
  • System Suitability and Standardization requirements
  • Calculations and Specifications
  1. USP Total Organic Carbon (TOC) methods (USPNF <643>)
  • Chemistry
  • Methodology
  • System Suitability requirements
  • Calculations and Specifications
  1. USP Assays and Impurities methods by HPLC (USPNF <621>)
  • Methodology
  • System Suitability (SS) requirements, calculations and specifications
  • % Purity, % Impurities, % Label Claim calculations and specifications
  1. USP Dissolution (USPNF <711>) and Drug release (USPNF <724>)
  • Review of USP dissolution methods (Apparatus 1 & 2), USP interpretation and calculations done in PHA 333
  • Discussion of USP Apparatus 3 - 7
  • Calculations and Specifications
  1. Introduction to USP validation and method transfer protocols (USPNF <1225>)
  1. Radiopharmaceuticals (USPNF <821>)

Essential Employability Skills

    •  Communicate clearly, concisely and correctly in the written, spoken and visual form that fulfils the purpose and meets the needs of the audience.

    •  Respond to written, spoken, or visual messages in a manner that ensures effective communication.

    •  Execute mathematical operations accurately.

    •  Apply a systematic approach to solve problems.

    •  Use a variety of thinking skills to anticipate and solve problems.

    •  Locate, select, organize, and document information using appropriate technology and information systems.

    •  Analyze, evaluate, and apply relevant information from a variety of sources.

    •  Interact with others in groups or teams in ways that contribute to effective working relationships and the achievement of goals.

    •  Manage the use of time and other resources to complete projects.

    •  Take responsibility for one's own actions, decisions, and consequences.

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Please visit the Academic Integrity website to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

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