TOPIC 1: Introduction Flashcards
A detailed examination of anything complex in order to understand its nature or to determine its essential features: a thorough study.
Analysis
It is a process of BREAKING UP or SEPARATION of compound or a mixture into its constituents.
Analysis
Analysis involves both _________ and _________ processes.
Physical & Chemical
If the analysis involves chemical process, it is called ?
Chemical analysis / Analytical Chemistry
Substances for analysis are called ?
Analyte
Examples of ANALYTE
SODIUM in peanut butter
NITRATE in water
O3 in the air
The medium in which the analyte is analyzed.
Matrix of the analyte
The medium in which the analyte is analyzed.
Matrix of the analyte
Analytical chemistry dealing with drugs both as bulk drug substance and as pharmaceutical products.
Pharmaceutical Analysis
Pharmaceutical Analysis is analytical chemistry dealing with drugs both as ___________ substance and as ____________.
bulk drug substance & pharmaceutical products
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
Pharmaceutical Analysis
Pharmaceutical analysis is 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
Defined as the application of analytical procedures used to determine the purity, safety and quality of drugs and chemicals.
Pharmaceutical Analysis
Pharmaceutical analysis is defined as the application of analytical procedures used to determine the ______ , _______, and _______ of drugs and chemicals.
purity
safety
quality
Qualitative Chemistry question
“What” is in the sample?
- 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
QUALItative Chemistry
- Determination of the proportion of components in a substance
- Determining the concentration of a compound in a solution
- Determining weight of a tablet
QUANtitative Chemistry
2 Main Types of Analysis
QUALItative & QUANTItative
Analysis of purity and quality of drugs and chemicals used in practice.
Qualitative-Quantitative Chemistry in Pharmacy
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
Qualitative-Quantitative Chemistry in Pharmacy
Any substance (except food and water) when taken into the body alters the body’s function either physically and/or psychologically.
Drug
Drug is a substance recognized by an official __________ or formulary.
pharmacopoeia
Drug is a substance intended for use in the _______ , _______ , __________ , _________ or __________ of disease.
diagnosis, cure, mitigation, treatment or prevention
A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
Drug
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
Drug
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.
Pharmaceutical product
Pharmaceutical Product process
Raw materials -> Compounding or manufacturing -> FPP (finished pharmaceutical product)
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.
Active Pharmaceutical Ingredient (API)
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.
pharmacological
Component of the finished product other than API.
Excipients
Excipients examples
Fillers
Colorants
Flavorants
Solvents
Preservatives
API examples
Glibenclamide, Ketoprofen, Riboflavin, Caffeine, Rosuvastatin Calcium
