Pharmaceutical Analysis - Ii
Pharmaceutical Analysis - Ii
MISSION
To uphold the highest standards of education rooted in the university’s
ideals of wellness, integrity, service, and excellence in the attainment of the
students’ full potential for nation building and positive societal change
through the embodiment of a transformative culture that enhances the
quality of life and responds to the exigencies of man and society.
INSTITUTIONAL OUTCOMES
Upon graduation from CDU, the student will:
● apply evidence-based knowledge and practices in promoting health and
wellness;
● create innovative solutions and interventions for complex health, societal,
and environmental concerns;
● demonstrate highest standards of ethical behaviors in the conduct of
service and the profession;
● exemplify transformational leadership in the workplace and community;
● provide compassionate and client-focused service in multicultural
settings;
● provide resources for sustainable and lifelong development of
communities;
● communicate effectively in diverse settings and contexts;
● engage in lifelong learning for nation-building and global adaptability; and
● engage in collaborative works with local and global partners.
CEBU DOCTORS’ UNIVERSITY
COLLEGE OF PHARMACY
# Dr. P. V. Larrazabal, Jr. Avenue, North Reclamation Area,
6014 Mandaue City, Cebu, Philippines
VISION
The College of Pharmacy envisions itself to be one of the globally-renowned providers of competent and compassionate Pharmacists committed to upholding the
University’s standard of transformative practice.
MISSION
The College of Pharmacy is committed to produce Pharmacy professionals equipped with the necessary knowledge, skills, and character to meet the demands of man
and society.
OBJECTIVES
The College of Pharmacy is committed to develop graduates who:
1. Possess sufficient knowledge and skills in the practice of pharmacy
2. Are morally upright, economically productive, and socially responsive
3. Has the necessary skills in research for knowledge advancement and improvement in pharmaceutical care delivery
4. Is a well-rounded health professional, responsible in providing drug therapy that improve a patient’s quality of life
PROGRAM OUTCOMES
Upon graduation, the pharmacy graduate will:
1. Practice pharmacy in a professional and ethical manner
2. Provide pharmaceutical care
3. Conduct relevant research and innovation to solve complex health, societal, and environmental concerns, and disseminate findings
4. Apply managerial and entrepreneurial skills
5. Communicate and facilitate effectively
6. Commit to lifelong learning and continuing personal and professional development
7. Work collaboratively with other professionals both in local and global context
8. Engage in programs geared towards sustainable and life-long development of communities
SHARED VALUES
P- Professionalism
We operate to a set of standards and observe the code of conduct that embodies excellence and proficiency.
H- Honesty
We stand for what is true and conduct best practices with integrity in all our endeavors.
A- Amity
We aim to be unified and involved in building camaraderie in our internal and external stakeholders and in promoting harmonious interprofessional collaboration.
R- Responsible
We hold ourselves to the highest standards of performance towards goals. We treat others fairly, honor our commitments, and are trustworthy and socially aware.
M - Multicultural
We treat all students equally and value individual contributions and differences. We encourage open and effective communication to foster respect, honesty and trust.
A- Adaptable
We are prepared for future challenges and are willing to embrace change. We respond to where our vocation takes us with resiliency.
Cy- Charity
We are service-oriented motivated by selfless concern for the welfare of the society.
CEBU DOCTORS’ UNIVERSITY
COLLEGE OF PHARMACY
# Dr. P. V. Larrazabal, Jr. Avenue, North Reclamation Area,
6014 Mandaue City, Cebu
COURSE SYLLABUS
_2nd__ SEMESTER, A.Y. _2022-2023_
COURSE INFORMATION
2 and 3 Demonstrate competence UNIT I 1.Defining the term Quality PLO1 ILO8 Discussion Long quiz
and knowledge on INTRODUCTION TO Control and Quality PLO3
general information on QC Assurance. PLO7 Group sharing
Quality Control section a. Quality Control and 2. Differentiate the
Quality organization of the QC and its
Assurance respective roles.
-Organization of QC 3. Identifying common quality
1. Materials and control tests performed on
Inspection different pharmaceutical
Control dosage forms.
2. Analytical 4. Describing the factors of a
laboratory good quality product and
3. Biological testing services.
Laboratory 5. Identifying presence of
4.QualityCoordinati specific adulterations in a
on pharmaceutical dosage form.
office 6. Analyzing Current Good
b. Standards and Manufacturing Practices in
Specifications Philippine setting.
c. Defects 7. Illustrating sound judgment
d. Sources and of application of CGMP.
Control of Quality 8.Planning an ideal setting for
Variation CGMP.
e. Three main areas
of QC
1. Raw Materials
QC
2. In-process QC
-Physical and
chemical
-Biologic and
Microbiological test
-Identity tests
-Quality tests
-Purity tests
3. Final Product
QC
f. Quality Control of
Various
Pharmaceutical
Dosage
forms
g. Adulterations
TOTAL QUALITY
MANAGEMENT
1. Definition of
common terms
CURRENT GOOD
MANUFACTURING
PRACTICE
GUIDELINES
ADMINISTRATIVE
ORDER
No. 43 S. 1999
4 and 5 Demonstrate competence UNIT II 1. Determining various PLO1 ILO8 Discussion Long quiz
and knowledge on STANDARDS AND standards of specification PLO3
standards and SPECIFICATIONS based on various organization PLO7 Group sharing
specification of different a. International
drug products Council for
Harmonization Quality
Guidelines
b. World Health
Organization
c. ASEAN
(Association of
Southeast Asian
Nations)
d. ISO (International
Organization of
Standardization)
e. CGMP (Current
Good Manufacturing
Practices)
6 Demonstrate competence UNIT III 1. Knowing the compendial PLO1 ILO8 Discussion Long quiz
and knowledge on COMPENDIAL requirements of different PLO3
compendial requirements REQUIREMENTS OF dosage form. PLO7 Group sharing
of pharmaceutical drug PHARMACUETICAL
product DRUG PRODUCTS
1. Compendial
Requirements for
Solid and semi-solid
dosage forms
2. Compendial
Requirements for
Liquid Dosage Forms
(Solutions &
Suspensions)
3. Compendial
Requirements for
Parenteral
7 to 15 Demonstrate competence UNIT IV 1. Enumerating and PLO1 ILO8 Discussion Long quiz
and knowledge on various INSTRUMENTAL describing the PLO3
instrumental methods of METHODS OF DRUG Physicochemical and PLO7 Group sharing
drug analysis ANALYSIS Instrumental methods used in
1. Basic Principles of Pharmaceutical Analyses. Reporting
UV-VIS Spectroscopy 2. Identifying and Contrasting
2. Atomic Emission different types of
Spectroscopy Chromatography
3. Fourier Transform
Infrared Spectroscopy
4. Flame Atomic
Absorption
Spectroscopy
5. Turbidimetry
6. Nephelometry
C. Basic Laboratory
methods
1. Chromatography
a. Column
b. Adsorption
c. Paper- Partition
d. Reverse –Phase
e. Ion-exchange
f. Molecular Exclusion
Chromatography
2. Thin Layer
Chromatography
3. Gas
Chromatography
a. Parts
b. Functions
4. High Pressure
Liquid
chromatography
a. Parts
b. Functions
16 Demonstrate competence UNIT V 1. Relating basic concept of PLO1 ILO8 Discussion Long quiz
and knowledge on Quality QUALITY CONTROL Statistics to Quality Control. PLO3
Control statistics STATISTICS PLO7 Group sharing
1. Definition 2. Showing skills in solving
2. Descriptive the needed factors in Reporting
Statistics statistics.
3. Specifications and 3. Explaining and solving
control specification and control limits
limits
a. X bar
b. R bar
c. P chart
d. C chart
Laboratory component
Learning Objective Content Teaching-Learning Activities Resources Needed Student Assessment Number of Hours
Exercise 1
PLO Experimentation Laboratory Short quiz 3
Moisture Determination
PLO Exercise 2 Experimentation Laboratory Short quiz
3
Weight Variation
PLO Exercise 3 Experimentation Laboratory Short quiz
3
Dissolution Apparatus
PLO Exercise 4 Experimentation Laboratory Short quiz
3
UV VIS Spectroscopy
PLO Exercise 5 Experimentation Laboratory Short quiz
3
Disintegration apparatus
PLO Exercise 6 Experimentation Laboratory Short quiz
3
Friability
PLO Exercise 7 Experimentation Laboratory Short quiz
3
Hardness and Thickness
PLO Exercise 8 Experimentation Laboratory Short quiz
3
Thin Layer chromatography
PLO Exercise 9 Experimentation Laboratory Short quiz
3
Specific rotation
PLO Exercise 10 Experimentation Laboratory Short quiz
3
pH determination
PLO Exercise 11 Experimentation Laboratory Short quiz
High Performance Liquid 3
chromatography
COURSE MAPPING
Program Outcomes
Upon graduation, the pharmacy graduate will:
1. Practice pharmacy in a professional and ethical manner
2. Provide pharmaceutical care
3. Conduct relevant research and innovation to solve complex health, societal, and environmental concerns, and disseminate findings
4. Apply managerial and entrepreneurial skills
5. Communicate and facilitate effectively
6. Commit to lifelong learning and continuing personal and professional development
7. Work collaboratively with other professionals both in local and global context
8. Engage in programs geared towards sustainable and life-long development of communities
Learning Resources:
Basic Readings Watson, David G. Pharmaceuticals analysis: a textbook for pharmacy students and pharmaceutical chemists, 4th ed. Singapore:
Elsevier. 2017.
Knevel, A.M. and Digangi, F.E., Jenkin’s Quantitative Pharmaceutical Chemistry. USA: Mc Graw Hill. 1977.
Extended Readings Kar, A. Pharmaceutical Drug Analysis, 2nd ed. New Delhi: New Age International (P) Ltd., Publishers. 2005.
Remington’s Pharmaceutical Sciences, (2013) Philadelphia: Lippincott William and Wilkin
WHO expert committee on specifications for pharmaceutical preparations (2013) Geneva: World Health Organization
British Pharmacopeia 2017
USP 40: The United States Pharmacopeia: NF 35: the national formulary Rockville, Md. United States Pharmacopeial Convention.
2017.
Handbook of modern pharmaceutical analysis Amsterdam; Boston: Academic Press/Elsevier. 2011.
Harris, D.C. Quantitative Chemical Analysis, 9thEdition.New York: W.H. Freeman. 2015
Prepared by:
Name of Faculty
(signed)
Mae Quenie T. Pontanar
Faculty
Approved by:
ENRICO B. GRUET, MD
Vice-President for Academic Affairs
Date: _______________