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Pharmaceutical Analysis - Ii

This document contains information about the College of Pharmacy at Cebu Doctors' University, including its vision, mission, objectives, and outcomes. The college's vision is to be a globally recognized provider of competent and compassionate pharmacists committed to upholding high standards of practice. Its mission is to produce pharmacy professionals with the knowledge, skills, and character to meet societal needs. The program outcomes include practicing pharmacy ethically, providing pharmaceutical care, conducting research, and lifelong learning.
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0% found this document useful (0 votes)
401 views

Pharmaceutical Analysis - Ii

This document contains information about the College of Pharmacy at Cebu Doctors' University, including its vision, mission, objectives, and outcomes. The college's vision is to be a globally recognized provider of competent and compassionate pharmacists committed to upholding high standards of practice. Its mission is to produce pharmacy professionals with the knowledge, skills, and character to meet societal needs. The program outcomes include practicing pharmacy ethically, providing pharmaceutical care, conducting research, and lifelong learning.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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VISION

A globally recognized health- and service-oriented educational institution


with the highest standards of transformative practice

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

Course Code PHCEUTIC27 Pre-requisite Course/s PHARMACEUTICAL ANALYSIS I


(QUANTITATIVE PHARMACEUTICAL
CHEMISTRY)
Course Title PHARMACEUTICAL ANALYSIS II Co-requisite Course/s
(INSTRUMENTAL METHODS OF ANALYSIS)
Credit Units 3 UNITS (2 UNITS LECTURE, 1 UNIT LAB) Date Last Revised
Instructor’s Information Current Revision Date 1/19/2023
Instructor’s Name MAE QUENIE T. PONTANAR Class Information
Office Designation Faculty Schedule BLOCK A
LEC 3-5PM WEDS
LAB 130-430PM THURS
BLOCK B
LEC 1030-1230 THURS
LAB 730-1030AM WEDS
Email Address [email protected] Room Assignment 204B, 419
Contact Number 09328736528 Degree Program BS in Pharmacy
Consultation Time Mon (9am to 11am); (2pm to 4pm)
Course Description:
This is a continuation of Quality Control I with application of instrumental methods of analysis. It includes the principles, organization and function of quality control in the
pharmaceutical and cosmetic industry. In process test, the use of quality control charts for solid pharmaceuticals, stability testing as well as quality assurance functions in
various stages of manufacture are discussed.
PROGRAM LEARNING OUTCOMES: YEAR LEVEL INTENDED LEARNING OUTCOMES:
A graduate of Bachelor of Science in Pharmacy should be able to: At the end of the second-year level, the students should be able to:
1. Practice pharmacy in a professional and ethical manner 1. Explain the preparation of drugs into various dosage forms to ensure quality of medicinal
2. Provide pharmaceutical care and pharmaceutical products.
3. Conduct relevant research and innovation to solve complex 2. Demonstrate knowledge of drugs of biological origin, and the pharmacy and chemistry of
health, societal, and environmental concerns, and disseminate pharmaceutical products.
findings 3. Read and interpret prescription correctly.
4. Apply managerial and entrepreneurial skills 4. Critically evaluate scientific evidence for research and decision-making.
5. Communicate and facilitate effectively 5. Relate biological and physiological concepts to pharmacy (drug, biotechnology products,
6. Commit to lifelong learning and continuing personal and and diseases).
professional development 6. Investigate the harmful and beneficial effects of microorganisms (including antimicrobial
7. Work collaboratively with other professionals both in local and resistance and its clinical impact) as well as the helminths and measures to control these
global context parasites.
8. Engage in programs geared towards sustainable and life-long 7. Demonstrate understanding of immunization process and types of immunobiologicals.
development of communities 8. Demonstrate methods in utilizing instrumentation analyses as required by pharmacopeial
standards.
9. Provide healthcare information to various clients (patients, healthcare professionals, and
public).
10. Recognized important elements of the patient’s health profile and health promotion.
11. Demonstrates appreciation of the major art forms.

Essential Learning Constructive Learning


Program Intended
Teaching/
Declarative Learning Learning Assessment
Week Content Standards Functional Knowledge Learning
Knowledge Outcomes Outcomes Tasks (ATs)
Activities (TLAs)
(PLOs) (ILOs)
Demonstrate competence University Vision 1. Explaining the Vision,
on University, College and Mission Goals Mission Goals of the
course orientation College Vision University and College
1 Mission Goals and 2. Explaining the standard of
objectives practice in the course
Course Orientation 3. Identifying responsibilities
as students

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

Course Outcome (COs)


PO1 PO2 PO3 PO4 PO5 PO6 PO7 PO8
At the end of the course, the student will be able to: P P
CO1. Explain the importance of Quality in the manufacture of drugs.
CO2. Explain the parts and functions of instruments used in pharmaceutical analysis of P P
Quality of medicines.
CO3. Apply principles of each instruments in determining Quality of drug products. P P
Legend: I -Introduced (The course provides learning opportunities to which students can attain foundational knowledge, skills, and attributes to pursue the outcome
further.)
P -Practiced (The course provides learning opportunities to which students can reinforce or further develop the knowledge, skills and attributes described in
the outcome statement), and
D -Demonstrated (The course provides learning opportunities to which students can demonstrate knowledge, skills, and attributes described in the outcome
statement.)

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

Reviewed and Checked by:

MAE QUENIE T. PONTANAR, RPh, MSc ,  


Head, Curriculum and Teaching Learning Committee
College of Pharmacy
Date: ___1/20/23_____
Recommending Approval: Evaluated by:

JAN HARMONY A. CESAR, MSPh, MATh JEROME L. COLIGADO, PTRP, MSPT, MA


Chair, College of Pharmacy Quality Assurance Committee Head, Institutional Standards and Quality Assurance
Dean, College of Arts and Sciences Date: _______________
Date: _______________

Approved by:

ENRICO B. GRUET, MD
Vice-President for Academic Affairs
Date: _______________

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