PHA333 - Pharmaceutical Analysis

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Last revision date Jul 11, 2019 3:08:23 PM
Last review date Jul 11, 2019 3:08:23 PM

Subject Title
Pharmaceutical Analysis

Subject Description
This is a one-semester laboratory oriented subject intended to introduce students to the world of pharmaceutical analysis. Selected physical and chemical techniques used in the control of raw materials and finished dosage forms are emphasized, especially USP and BP methods. Students should be aware that this course does not attempt to teach basic science but instead encourages students to apply their previously acquired knowledge, especially of chemistry and mathematics, in the pharmaceutical laboratory.

Credit Status
One credit towards the Chemical Laboratory Technology (Pharmaceutical) diploma

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

1. Must be familiar with Good Manufacturing Practice (GMP) regulations, as it relates to quality control laboratory data acquisition, record keeping and good documentation practices.
2. Will have successfully carried out and completed various laboratory exercises emphasizing the analysis of pharmaceutical raw materials, in-process tests and finished product tests.
3. Must be able to follow Standard Operating Procedures (SOPs) within the pharmaceutical laboratory.
4. Will be able to write Certificate of Analysis (C of A), long term stability protocols and reports for drug substances and finished products.
5. Must demonstrate that they can apply their knowledge of chemistry and mathematics
[i.e., obtained from CHM 273 and MTH 273] towards interpreting the Pharmacopoeial compendia (e.g., BP and USP-NF, USP Supplements and on-line USP Reference Standard Catalogue).
6. Must demonstrate that they can completely and correctly solve pharmaceutical calculations such as % purity and % label claim.
7. Must be able to demonstrate use of chemical and pharmaceutical software/firmware such ChemStation UV-Vis software and VanKel Dissolution apparatus firmware.

Academic Integrity
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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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Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.