PHA052: Pharmaceutical Analysis 2

Module # 1 Teacher’s Guide

Lesson title: Introduction to Pharmaceutical Analysis 2 Materials: Book, pen and notebook,
(Instrumental Methods of Analysis) index card/class list
Learning Targets:
References:
At the end of the module, students will be able to:
Watson, David G. (2017).
1. Demonstrate understanding of the terminologies used
Pharmaceuticals analysis: a textbook for
in the pharmaceutical analysis;
pharmacy students and pharmaceutical
2. Demonstrate competence in the analysis of
chemists, 4th ed. Singapore: Elsevier
pharmaceuticals using spectrophotometer.;
3. Define principles of spectroscopy methods; and,
4. Explain the application of spectroscopy as a method of
analysis for pharmaceuticals.

A. LESSON PREVIEW/REVIEW

SUBJECT ORIENTATION

The instructor will be starting to introduce himself/herself to the class and the assigned subject,
Pharmaceutical Analysis 2 Lecture. The course outline will be distributed and discussed accordingly. Listed
below are the additional information vital in orientation:

1. The calendar of activities for major examinations must be relayed.

2. Classroom rules and regulations will be informed per the instructor’s discretions.
3. Computation of grades specific for this subject must be thoroughly explained to students.
4. The essence and significance in grade computation of these modules must be introduced.
5. If this is the first subject of the class, the instructor must initiate an election for block officers.
6. Any other information that will be deemed necessary by the instructor must be properly coordinated to the
class.

B. MAIN LESSON

I. INTRODUCTION

Pharmaceutical analysis is a branch of chemistry, which involves a series of processes for the
identification, determination, quantitation, and purification. This is mainly used for the separation of the
components from the mixture and for the determination of the structure of the compounds.

The substance may be a single compound or a mixture of compounds and it may be in any of the
dosage forms. The substances used as pharmaceuticals are animals, plants, microorganisms, minerals and
various synthetic products.

This document is the property of PHINMA EDUCATION

 PHA052: Pharmaceutical Analysis 2
Module # 1 Teacher’s Guide

Based upon the determination type, there are mainly two types of analytical methods. They are as
follows:

● Qualitative analysis: This method is used for the identification of the chemical compounds.
● Quantitative analysis: This method is used for the determination of the amount of the sample.

❖ Definition of Terms
● Accuracy - a measure of how close a measurement is to the correct or accepted value of the quantity
being measured.

● Analyte -  substance being analyzed by (for example) mass spectrometry, infrared spectroscopy, NMR
spectroscopy, or chromatography.

● Analytical Blank - this consists of all the reagents or solvents used in an analysis without any of the
analyte being present.

● Calibration - involves comparison of the value or values of a particular parameter measured by the
system under strictly defined conditions with pre-set standard values.

● Certificate of Analysis - document with the results of all tests conducted on material to show compliance
or non-compliance with the standard specifications.

● Finished product specification - this should cover all characteristics that affect the proper performance,
purity, safety, and stability of the product.

● Formula - this is concise and precise statement of the ingredients that comprise the product, together with
the percentage and/or weight of each

● Intermediate Precision - expresses within-laboratory variation precision when the analysis is carried out
by different analysis, on different days and with different equipment

● Linearity - ability to elicit test results that are directly, or by a well-defined mathematical transformation,
proportional to the concentration of analyte in samples within a given range.

● Medical Product - (a) any substance or combination of substances presented as having properties for
treating or preventing disease in human beings and/or animals; or (b) any substance or combination of
substances that may be used in or administered to human beings and/or animals with a view either to
restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or
metabolic action, or to making a medical diagnosis

● Monograph - Document that specifies all the tests to be conducted on a product and/or appropriate
references containing details of procedure and expected result.

● Precision - a measure of how close a series of measurements are to one another.

● Quality – totality of characteristics or features of a product that bears its capacity to satisfy stated or
implied needs.

This document is the property of PHINMA EDUCATION

 PHA052: Pharmaceutical Analysis 2
Module # 1 Teacher’s Guide

● Quality Assurance – sum total of the organized arrangements made with the object of ensuring that
products will be consistently of the quality required by their intended use.

● Quality Control – part of GMP concerned with sampling, specifications, testing, organization,
documentation, and release procedures.

● Raw Material Specification - this should enumerate the characteristics of all the materials that go into the
product and the permissible range of purity of each ingredient.

● Repeatability - expresses the precision obtained under the same operating conditions over a short
interval of time. It can also be termed intra-assay precision. It is likely that the assay would be repeated by
the same person using a single instrument. Within repeatability it is convenient to separate the sample
preparation method from the instrument performance.

● Reproducibility - expresses the precision among laboratories. Such a trial would be carried out when a
method was being transferred from one part of a company to another.

● Robustness - evaluated in order to determine how resistant the precision and accuracy of an assay are to
small variations in the method.

● Sample - Finite number of objects selected from a batch.

● Selectivity - a measure of how capable it is of measuring the analyte alone in the presence of other
compounds contained in the sample

● Spectrometry - amount of radiant energy that has interacted with the chemical species. It is also the
power of transmitted, fluorescent, reflected or emitted light .

● Spectrophotometry - measurement of radiant energy absorbed or transmitted at a definite and narrow

wavelength.

● Spectroscopy - is the study of the absorption and emission of light and other radiation by matter.

● Standard Operating Procedure (SOP) - a step-by-step method on how to go about a job.

● System Suitability - designed to evaluate the components of the analytical system in order to show that
the performance of the system meets the standards required by the method.

This document is the property of PHINMA EDUCATION

 PHA052: Pharmaceutical Analysis 2
Module # 1 Teacher’s Guide

C. CHECK FOR UNDERSTANDING

The instructor will prepare 10-15 questions that can enhance critical thinking skills. Students will work by
themselves to answer these questions and write the rationale for each question.

Multiple Choice

(For 1-10 items, please refer to the questions in the Rationalization Activity)

RATIONALIZATION ACTIVITY (DURING THE FACE TO FACE INTERACTION WITH THE STUDENTS)
The instructor will now rationalize the answers to the students and will encourage them to ask questions and to
discuss among their classmates for 20 minutes.

1. Expresses the precision obtained under the same operating conditions over a short interval of time.
a. Reproducibility
b. Precision
c. Intra-assay Precision
d. Selectivity
Answer: C
Rationale: Intra-assay Precision is another term for Repeatability.

2. A measure of how close a measurement is to the correct or accepted value of the quantity being
measured.
a. Accuracy
b. Calibration
c. Precision
d. NOTA
Answer: A
Rationale: Accuracy is a measure of how close the measurement is to the correct quantity while Precision is
the closeness of a series of measurements to one another.

3. Document that specifies all the tests to be conducted on a product and/or appropriate references containing
details of procedure and expected result.
a. Raw Material Specification
b. Certificate of Analysis
c. Monograph
d. Formula
Answer: C. Monograph
Rationale: Raw Material Specification involves the enumeration of the characteristics of all the materials that
go into the product and the permissible range of purity of each ingredient. Certificate of Analysis is a document
with the results of all tests conducted on material to show compliance or non-compliance with the standard
specifications. Whereas, Formula, is a concise and precise statement of the ingredients that comprise the
product, together with the percentage and/or weight.

This document is the property of PHINMA EDUCATION

 PHA052: Pharmaceutical Analysis 2
Module # 1 Teacher’s Guide

4. Designed to evaluate the components of the analytical system in order to show that the performance of the
system meets the standards required by the method.
a. Standard Operating Procedure
b. System Suitability
c. Quality Assurance
d. Intermediate Precision
Answer: B. System Suitability
Rationale: Standard Operating Procedure is a step-by-step method on how to go about a job. Quality
Assurance is the sum total of the organized arrangements made with the object of ensuring that products will
be consistently of the quality required by their intended use. Intermediate Precision is an expression
within-laboratory variation precision when the analysis is carried out by different analysis, on different days and
with different equipment.

5. Ability to elicit test results that are directly, or by a well-defined mathematical transformation, proportional to
the concentration of analyte in samples within a given range.
a. Calibration
b. Quality Analysis
c. Linearity
d. Selectivity
Answer: C. Linearity
Rationale: Calibration involves comparison of the value or values of a particular parameter measured by the
system under strictly defined conditions with pre-set standard values. Quality Analysis, on the other hand,
involves quality assurance and quality exploration that are often performed in setting quality design. Selectivity
is a measure of how capable it is of measuring the analyte alone in the presence of other compounds
contained in the sample.

6. This is mainly used for the separation of the components from the mixture and for the determination of the
structure of the compounds.
a. Quality Analysis
b. Quantitative Analysis
c. Pharmaceutical Analysis
d. Qualitative Analysis
Answer: C
Rationale: Pharmaceutical Analysis is a branch of chemistry, which involves the series of processes for the
identification, determination, quantification, and purification.

7. This covers all characteristics that affect the proper performance, purity, safety, and stability of the product.
a. Finished Product Specification
b. Quality
c. Monograph
d. NOTA
Answer: A. Finished Product Specification

This document is the property of PHINMA EDUCATION

 PHA052: Pharmaceutical Analysis 2
Module # 1 Teacher’s Guide

Rationale: Quality is the totality of characteristics or features of a product that bears its capacity to satisfy
stated or implied needs. While Monograph is a document that specifies all the tests to be conducted on a
product and/or appropriate references containing details of procedure and expected result.

8. Measurement of radiant energy absorbed or transmitted at a definite and narrow wavelength.

a. Spectroscopy
b. Spectrophotometry
c. Spectrometry
d. NOTA
Answer: B. Spectrophotometry
Rationale: Spectroscopy is the study of the absorption and emission of light and other radiation by matter.
Spectrometry is the amount of radiant energy that has interacted with the chemical species. It is also the power
of transmitted, fluorescent, reflected or emitted light .

9. The study of the absorption and emission of light and other radiation by matter.
a. Spectroscopy
b. Spectrophotometry
c. Spectrometry
d. NOTA
Answer: A. Spectroscopy
Rationale: As defined

10. Expresses within-laboratory variation precision when the analysis is carried out by different analysis, on
different days and with different equipment.
a. Quality Control
b. Quality Assurance
c. Intermediate Precision
d. Linearity
Answer: C. Intermediate Precision
Rationale: Quality Control is part of GMP concerned with sampling, specifications, testing, organization,
documentation, and release procedures. Whereas, Quality Assurance is part of Quality Analysis that is
performed in setting quality design and Linearity is the ability to elicit test results that are directly, or by a
well-defined mathematical transformation, proportional to the concentration of analyte in samples within a
given range.

This document is the property of PHINMA EDUCATION

 PHA052: Pharmaceutical Analysis 2
Module # 1 Teacher’s Guide

D. LESSON WRAP-UP

Teacher directs the student to mark (encircle) their place in the work tracker which is simply a visual to help
students track how much work they have accomplished and how much work there is left to do. This tracker will
be part of the student activity sheet.

PERIOD 1 PERIOD 2 PERIOD 3

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

AL Strategy: MINUTE PAPER

After the instructor collects all papers, he/she will now summarize the topic. Towards the end of the class, ask
the students to bring out and write on a half sheet of paper written feedback to the following questions: Firstly,
what was the most meaningful or important thing they learned during the class. Secondly, the important
question remains unanswered. Make sure to position yourself at the door. Conversely, instruct the students to
file out towards the exit door and collect the “minute papers” as students depart from the room. Respond to
students’ feedback during the next class meeting or as soon as possible

Most meaningful or important thing they learned from this session: (Why did they find it meaningful or
important?)

________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________

Question which remains unanswered: (What will they do to find the answer?)
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________

This document is the property of PHINMA EDUCATION