TOPIC 1: Introduction

Question 1

A detailed examination of anything complex in order to understand its nature or to determine its essential features: a thorough study.

Answer 1

Analysis

Question 2

It is a process of BREAKING UP or SEPARATION of compound or a mixture into its constituents.

Answer 2

Analysis

Question 3

Analysis involves both _________ and _________ processes.

Answer 3

Physical & Chemical

Question 4

If the analysis involves chemical process, it is called ?

Answer 4

Chemical analysis / Analytical Chemistry

Question 5

Substances for analysis are called ?

Answer 5

Analyte

Question 6

Examples of ANALYTE

Answer 6

SODIUM in peanut butter
NITRATE in water
O3 in the air

Question 7

The medium in which the analyte is analyzed.

Answer 7

Matrix of the analyte

Question 8

The medium in which the analyte is analyzed.

Answer 8

Matrix of the analyte

Question 9

Analytical chemistry dealing with drugs both as bulk drug substance and as pharmaceutical products.

Answer 9

Pharmaceutical Analysis

Question 10

Pharmaceutical Analysis is analytical chemistry dealing with drugs both as ___________ substance and as ____________.

Answer 10

bulk drug substance & pharmaceutical products

Question 11

A branch of practical chemistry that involves a series of processes for:

• identification,
• determination,
• quantification and
• purification of a substance,
separation of the components of a solution or mixture,
• or determination of structure of chemical compounds

Answer 11

Pharmaceutical Analysis

Question 12

Pharmaceutical analysis is a branch of practical chemistry that involves a series of processes for:

Answer 12

• identification,
• determination,
• quantification and
• purification of a substance,
separation of the components of a solution or mixture,
• or determination of structure of chemical compounds

Question 13

Defined as the application of analytical procedures used to determine the purity, safety and quality of drugs and chemicals.

Answer 13

Pharmaceutical Analysis

Question 14

Pharmaceutical analysis is defined as the application of analytical procedures used to determine the ______ , _______, and _______ of drugs and chemicals.

Answer 14

purity
safety
quality

Question 15

Qualitative Chemistry question

Answer 15

“What” is in the sample?

Question 16

• Identification
• Composition determination
• Ascertainment of impurities
• Determining the elemental composition of a molecule
• Describing the color of the tablet
• Presence of impurities in the sample

Answer 16

QUALItative Chemistry

Question 17

• Determination of the proportion of components in a substance
• Determining the concentration of a compound in a solution
• Determining weight of a tablet

Answer 17

QUANtitative Chemistry

Question 18

2 Main Types of Analysis

Answer 18

QUALItative & QUANTItative

Question 19

Analysis of purity and quality of drugs and chemicals used in practice.

Answer 19

Qualitative-Quantitative Chemistry in Pharmacy

Question 20

Applied in industry, medicine, environment.

Analysis of the chemical constituents found in human body.

Analysis of medicinal agents and their metabolites found in biological systems

Answer 20

Qualitative-Quantitative Chemistry in Pharmacy

Question 21

Any substance (except food and water) when taken into the body alters the body’s function either physically and/or psychologically.

Answer 21

Drug

Question 22

Drug is a substance recognized by an official __________ or formulary.

Answer 22

pharmacopoeia

Question 23

Drug is a substance intended for use in the _______ , _______ , __________ , _________ or __________ of disease.

Answer 23

diagnosis, cure, mitigation, treatment or prevention

Question 24

A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.

Answer 24

Drug

Question 25

A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes

Answer 25

Drug

Question 26

Any material or product intended for human or veterinary use presented in its finished dosage form, or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state.

Answer 26

Pharmaceutical product

Question 27

Pharmaceutical Product process

Answer 27

Raw materials -> Compounding or manufacturing -> FPP (finished pharmaceutical product)

Question 28

Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient.

Answer 28

Active Pharmaceutical Ingredient (API)

Question 29

API produce ____________ activity or other direct effect in diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body.

Answer 29

pharmacological

Question 30

Component of the finished product other than API.

Answer 30

Excipients

Question 31

Excipients examples

Answer 31

Fillers
Colorants
Flavorants
Solvents
Preservatives

Question 32

API examples

Answer 32

Glibenclamide, Ketoprofen, Riboflavin, Caffeine, Rosuvastatin Calcium