Introduction to Pharmaceutical Analysis Flashcards
Methods for determining the chemical composition of samples of matter
Analytical Chemistry
yields information about the identity of
atomic or molecular species or the functional groups in the sample
Qualitative Method
provides numerical information as to the
relative amount of one or more of these components.
Quantitative MEthod
The process of a quantitative determination of a
chemical substance from a given sample
Asay
Types of Method of Drug Analysis
Nature of Sample
Size of Sample
Extent of Analysis
What is the classifications of nature of sample
Physical
Chemical
Biological
Instruments, Device
Physical
Reagents, Compounds, substances
Chemical
Living organisms, urine, animals, microorganisms
Biological
What are the classifications of Size of Sample?
Macroanalysis
Semi-microanalysis
Microanalysis
Submicroanalysis
Ultramicroanalysis
0.1 g or more
Macroanalysis
0.1 g - 1 g
Semi-microanalysis
0.01 g - 0.1 g
Microanalysis
0.001 g - 0.01 g
Submicroanalysis
<0.001 g
Ultramicroanalysis
The sum of total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and quality systems are maintained
Quality Assurance
Checking or testing that specifications are met
(PIC/s cGMP 2018)
Quality Control
Ensures the safety, efficacy, stability and purity
of raw materials and drug products.
Quality Control
• identification, determination, quantification and
purification of a substance;
• separation of the components of a solution or
mixture; or
• determination of structure of chemical compound
Pharmaceutical analysis
analysis of raw materials active pharmaceutical ingredients (APIs), intermediates, excipients, pharmaceutical substances and finished products
Pharmaceutical Analysis
Classification of Analytical Methods of Techniques
Separation
Qualititative Analysis
Quantitative Analysis
What are the classical methods of separation techniques
Precipitation
Extraction
Distillation
What the classical methods of Qualititative analysis
Chemical tests
B.P.
M.P
Solubility
Odor,
Optical activitt
Refractive index
What is the classical methods of the technique quantitative analysis
Titrimetry, Gravimetry, Coulometry
what are the instrumental methods of separation techniques
Chromatography,
electrophoresis
what are the instrumental methods of the technique quantitative analysis
UV/Vis spectrometry,
infrared spectrometry,
MS, NMR spectrometry
what are the instrumental methods of quantitative analysis
Potentiometry,
voltammetry,
spectrophotometry, AAS,
thermometric methods,
kinetic methods
Securing or getting a representative sample from
a given population
Sampling
what are the two types error
Indeterminate
Determinate
Aka Random Error
indeterminate