Pharmaceutical Analysis 1 – Day 1 Comprehensive Notes

Course Information

• Course: Pharmaceutical Analysis 1 (PHAN 111)
• Credit Units: 4 units total
  • Lecture – 3 units (9 h/week)
  • Laboratory – 1 unit (9 h/week)
• Course Placement: First Year, Summer Term
• Prerequisite/Co-requisite: None
• Lecturer: Cristina G. Sabroso
• Rationale: Applies principles of pharmaceutical analysis to evaluate drugs and drug products.
• Focus: Utilization of titrimetric analyses and other tests required by pharmacopeial standards.
• Course Outcome: Demonstrate competency in pharmaceutical analysis and decision-making based on compendial requirements.

Course Overview & Weekly Schedule

• Week 1
  • Course orientation, receipt of syllabus
  • OLFU & College V-M-O, core values
  • Diagnostic test
  • Introductory terminologies
  • Reflection paper (assignment)
  • Discussion Board #1: Quality control & regulation cases
• Week 2 – Methods of Analysis & Pharmacopeia
  • Quiz 1
  • Assignment 1 due
• Week 3 – Data Quality
• Weeks 4-5 – Volumetric Methods (General ⇢ Alkalimetry)
  • Quiz 2 & 3
  • Assignment 2 & 3
• Week 6 – PRELIMINARY EXAMINATION
• Week 7 – Volumetric: Acidimetry
• Week 8 – Volumetric: Non-aqueous & Kjeldahl methods
• Week 9 – Volumetric: Argentometry
  • Quiz 4
  • Assignment 4
  • Discussion Board #2 (accuracy & efficiency)
• Week 10 – Volumetric: Complexometry
  • Quiz 5
  • Assignment 5
• Week 11 – Volumetric: REDOX titrations
  • Quiz 6
  • Assignment 6
• MIDTERM EXAMINATION (after Week 11)
• Week 13 – Gravimetric Method
• Week 14 – Analysis of Crude Drugs: Ash & Water Content
  • Quiz 7
  • Discussion Board #3 (analytical chemistry for research)
• Week 15 – Extractives
  • Quiz 8
  • Assignment 7
• Week 16 – Constants of Fats, Fatty Oils, Resins & Fatty Substances
  • Quiz 9
• Week 17 – Analysis of Volatile Oils
  • Quiz 10
  • Assignment 8
• Week 18 – FINAL EXAMINATION

Assessment & Grading Scheme

Lecture Component 70 %:
• Quizzes 30 %
• Prelims 20 %
• Midterms 20 %
• Finals 30 %
• Attendance 5 %

Laboratory Component 30 %:
• Quizzes 30 %
• Worksheets 15 %
• Performance 10 %
• Finals 20 %
• Attendance 5 %

Special Quizzes: Only $70\%$ of raw score recorded.
Major exams administered only during scheduled periods; no removal exams.

Attendance Policy (CHED Sec. 1551)

• Absence ceiling: >$20\%$ of total contact hours → no course credit.
  • 6-unit course: 24 h
  • 5-unit: 20 h
  • 4-unit: 16 h
  • 3-unit: 12 h
  • 2-unit: 8 h
  • 1-unit: 4 h
• Tardiness ≥15 min = 1 absence.
• Late enrolment time counted as absence.
• Excused absence ≠ exemption from missed work.

Mathematical note: Maximum allowed absences
$A<em>{max}=0.20\times H</em>{total}$

Institutional Vision, Mission & Core Values

OLFU Vision

• Premier inclusive university dedicated to improving “man as man” through excellent education & compassionate value formation.

OLFU Mission (key verbs)

• Commit, Develop, Nurture, Respond, Inculcate, Imbue, Uphold.
  (Addresses education quality, capability maximization, leadership, research, community outreach, nationalism, virtues of truth-justice-integrity-compassion-faith.)

Core Values ("ACHIEVER")

• A – Aspires to do best
• C – Credible & Compassionate
• H – Hardworking & Honorable
• I – Inspiration to others
• E – Efficient, Effective, Ethical
• V – Visionary
• E – Entrepreneurial, Employable, Excellent work habits
• R – Responsible

College of Pharmacy Vision & Mission

• Vision: Top-notch provider of excellent pharmacy education compliant with industry standards.
• Mission: Produce ethical, competent, research- & community-oriented, environmentally conscious pharmacists via responsive curriculum & innovative practicum.

Program Learning Objectives (BS Pharmacy Graduate)

1. Practice pharmacy ethically & professionally.
2. Provide pharmaceutical care.
3. Conduct & disseminate research.
4. Apply managerial & entrepreneurial skills.
5. Communicate & facilitate effectively.

Year-Level Intended Outcomes (1st Year)

• Appreciate scope of pharmacy as health profession.
• Understand chemical, physical, biological processes in pharma sciences.
• Recognize healthcare system components & importance of pharmacovigilance.
• Perform calculations & lab techniques.
• Grasp plant morphology & pharmacognosy.
• Relate ethics to administration & leadership.
• Identify pharmacy-operation components; employ management skills.
• Exhibit self-awareness & social interaction skills.
• Communicate to appropriate audiences.
• Appreciate mathematics relevance.
• Connect molecular → systemic body functions incl. immunization impact.
• Demonstrate adult-vaccine administration technique.
• Practice good housekeeping.

Introduction to Pharmaceutical Analysis – Session Outcomes

• Define “Pharmaceutical Analysis”.
• Describe related terminology.

Key Definitions

• Analysis: detailed examination of something complex to understand its nature; involves breaking a compound/mixture into constituents using physical & chemical processes.
• Analytical Chemistry: field focused on chemical composition determination.
• Analyte: the substance being measured.
• Matrix: medium containing the analyte.
• Pharmaceutical Analysis: analytical chemistry dealing with drugs as bulk substances & finished products; involves identification, determination, quantification, purification, component separation, and structural elucidation to assure purity, safety, quality.

Drug

• Any substance (excluding food & water) that alters body function physically and/or psychologically when taken.
• Also: Substance recognized by official pharmacopoeia/formulary; intended for diagnosis, cure, mitigation, treatment, or prevention of disease.

Pharmaceutical Product

• Material/product for human or veterinary use in finished dosage form or as starting material; subject to pharmaceutical legislation in exporter/importer states.

Active Pharmaceutical Ingredient (API)

• Substance/mixture used in drug manufacture that becomes active ingredient producing pharmacological effect.

Excipient

• Any finished-product component other than the API (e.g., fillers, colorants, flavorants, solvents, preservatives).

Two Main Types of Analysis

1. Qualitative Chemistry
   • Answers “What is in the sample?”
   • Identification, composition determination, impurity ascertainment.
2. Quantitative Chemistry
   • Answers “How much is in the sample?”
   • Determines proportion/amount of each component.

Qualitative vs Quantitative Exercise (Examples)

• Qualitative statements:
  1. “They eat all the time.”
  2. “The president is very much liked.”
  3. “She saves a lot from her daily allowance.”
  4. “The cruise ship she saw was huge.”
  5. “The cat is very fat.”
• Corresponding quantitative conversions might include:
  • #1 → “They eat $5$ meals per day.”
  • #2 → “Approval rating =87\%.$”
  • #3 → “She saves \text{₱}50 daily.”
  • #4 → “Ship length =300\,\text{m}.$”
  • #5 → “Cat weighs 8.2\,\text{kg}.$”

Applications in Pharmacy & Related Fields

• Ensuring purity & quality of drugs/chemicals used in practice.
• Industrial QC, medical diagnostics, environmental monitoring.
• Determining chemical constituents & metabolites in biological systems.
• Supporting regulatory submissions & compliance with pharmacopeial standards.
• Protecting public health through accurate dosage forms & impurity profiling.

Components of Drug Products – Identifying APIs & Excipients

• Example 1 (Glibenclamide tablet):
  • API – Glibenclamide 5\,\text{mg}.$<br /> • Excipients – Croscarmellose Na, corn starch, aspartame Na, mint, silicon dioxide, magnesium stearate, color blend, fast-dissolving granulation.</p></li> <li><p>Example 2 (Ketoprofen / Riboflavin / Caffeine capsules): <br /> • APIs – Ketoprofen 1.25 g, Riboflavin 10 g, Caffeine 3 g (per 100 caps). <br /> • Excipients – Sodium bicarbonate, silica gel.</p></li> <li><p>Example 3 (Rosuvastatin effervescent): <br /> • API – Rosuvastatin calcium$1.00\%.$$
  • Excipients – Diluent 5 %, Effervescent couple 80 %, Binder 5 %, Lubricant 0.5 %, Sweetener 4 %, Other 4.5 %.

Ethical/Regulatory Implication: Accurate API identification & quantification are critical for dosage accuracy, patient safety, and regulatory approval.

Reference Materials

• Textbook: Knevel & Digangi, “Jenkin’s Quantitative Pharmaceutical Chemistry,” 1977.
• Watson DG, “Pharmaceutical Analysis,” 4th ed., 2017.
• Remington’s Pharmaceutical Sciences, 2013.
• WHO Expert Committee on Specifications for Pharmaceutical Preparations.
• British Pharmacopoeia, 2017.
• United States Pharmacopeia 40 / National Formulary 35.
• “Handbook of Modern Pharmaceutical Analysis,” 2011.
• Harris DC, “Quantitative Chemical Analysis,” 9th ed., 2015.

Practical & Philosophical Notes

• Analytical data underpins ethical decision-making in drug development and public health policy.
• Quality by Design (QbD) and continual improvement require precise analytical measurements.
• Environmental consciousness: monitoring pharmaceutical residues aligns with OLFU’s mission.
• Professional competency includes both technical proficiency and adherence to virtues of integrity & compassion.

Contact & Support

• Questions? Reach your lecturer via institutional email: @fatima.edu.ph