PFT301 - Lab Assay Methods I

Outline info
Semester
School
Last revision date 2017-05-29 00:41:43.697
Last review date 2017-07-17 00:16:29.086


Subject Title
Lab Assay Methods I

Subject Description
This laboratory-oriented subject addresses techniques and methods used in pharmaceutical analysis. Pre-lab and post-lab lectures delve into the theory of separative and analytical techniques and include clarification of relevant pharmaceutical terminology. PFT301 also provides an introduction to thin layer chromatography. (Lectures and Labs)

Credit Status
One credit toward the Industrial Pharmaceutical Technology Certificate Program

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

1. Use physio-chemical methods for the identification of raw materials.

2. Demonstrate methods for the assay of finished products (tablets and ointments) according to various pharmacopoeias (or alternate methods used in industry).

3. Explain the standard and purity needed of the raw material (excipient ingredients) used in the drug industry.

4. Examine various techniques used in the analysis of finished products.

5. Demonstrate the techniques used in the analysis of active raw materials used in finished products.

6. Demonstrate familiarity with the various instrumental analysis techniques used in the drug industry such as: titration, use of ultra violet spectrophotometer, refractometer, viscometer and chemical balance.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

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 Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
None

Topic Outline
7 Week Delivery Mode:

TOPIC
GMPs, SOPs
data documentation, laboratory safety, WHMIS overview, pharmaceutical terms and definitions, in process physical testing of solid dosage forms, USP, Seneca In House Method

LAB
Weight variation of compressed tablets,  size uniformity of tablets using micrometer,  tablet hardness evaluated using Van Kel hardness tester,  tablet friability, disinteregration (USP<701>) using Hanson research disintegration test system.

TOPIC
Review
Introduction to USP, raw material testing,  theory of ID tests, chemical tests and spectroscopic (IR) techniques used for identification, theory of limit tests according to USP

LAB
Calcium ID test
Chloride ID Test
ASA ID test A
ASA ID test B
Heavy metal limit test

TOPIC
Review
Theory of drug assay by different techniques, drug standards, standardization of volumetric solutions using analytical standards, assay by titration of Naproxen

LAB
Purity determination of Naproxen drug substance by titration

TOPIC
Review
Importance of dissolution testing, bioequivalence, in-vivo and in-vitro testing, theory of dissolution and dissolution profiling, use of UV/VIS spectrophotometry for determining drug concentrations in solution, standard curve

LAB
Dissolution profile of sodium salicylate tablets

TOPIC
Review
POTENCY determination of pharmaceutical finished products, uniformity of dosage forms-weight variation, content uniformity, assay of ASA by back titration 

LAB
BP method for the determination of the potency of ASA tablets

TOPIC
Review
Introduction to stability testing, stability indicating tests, stability protocols, long term and accelerated stability, monitoring the stability of Acetaminophen, Review of the theory of UV/VIS spectrophotometry 

LAB
Modified USP method for long term stability testing of 325mg acetaminophen USP tablets

Mode of Instruction

  • Lecture
  • Laboratory technique demonstration
  • Practical laboratory experience

Prescribed Texts
PHA 333 Introductory Pharmaceutical Testing Methods, Dr. Courtney Henry, ISBN #  0-00267-132-B, School of Bio/Chem, Seneca College  

Reference Material
Recommended

  • U.S. Pharmacopoeia - latest edition
  • British Pharmacopoeia - latest edition
  • National Formulary - latest edition
  • Remington's Practice of Pharmacy - latest edition
  • U.S. Dispensatory - latest edition
  • Introduction to Chromatography, Abbot and Andrews, Longmans

Required Supplies
All students must wear a laboratory coat and safety glasses while in the lab.  This requirement is mandatory and consistent with safe practice.  Anyone not having the mandatory requirements will be asked to leave the lab.

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
OR
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


Modes of Evaluation
Assignments

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecacollege.ca

LAB COURSES
Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

Grading is based on the following marking scheme:
Project 10%
7 Lab Reports (5% each) 35%
Quizzes 15%
Final Exam 40%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS

Approved by: Denis Gravelle