PRELIM 01 - Pharmaceutical Analysis Flashcards
Deals with methods for determining the chemical composition of states of matter
Analytical chemistry
Yields information about the identity of atomic or molecular species
Qualitative method
Provides numerical information as to the relative amount of one or more of these components
Quantitative method
3 classifications of drug analysis according to nature of sample
Physical, Chemical, Biological
The process of a quantitative determination of a chemical substance from a given sample
Assay
5 classifications of drug analysis according to 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
3 classifications of drug analysis according to extent of analysis
Proximate, Ultimate, Partial
Amount of each element in a sample is determined
Proximate
The perfect of extractive from a crude drug represents a single chemical species
Ultimate
Determines selected constituents in the sample
Partial
The sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required
Quality assurance (QA)
Checking or testing that specifications are met
Quality control (QC)
A branch of practical chemistry that involves a series of processes for identification, determination, quantification, and purification of a substance
Pharmaceutical analysis
3 Separation techniques (classical methods)
Precipitation, Extraction, Distillation
2 Separation techniques (instrumental methods)
Chromatography, Electrophoresis
7 Qualitative analysis techniques (classical methods)
Chemical tests, b.p., m.p., Solubility, Odor, Optical activity, Refractive index
4 Qualitative analysis techniques (instrumental methods)
UV/Vis spectrometry, Infrared spectrometry, MS, NMR spectrometry
3 Quantitative analysis techniques (classical methods)
Titrimetry, Gravimetry, Coulometry
6 Quantitative analysis techniques (instrumental methods)
Potentiometry, Voltammetry, Spectrophotometry, AAS, Thermometric methods, Kinetic methods
Securing or getting a representative sample from a given population
Sampling
2 types of error
Indeterminate, Determinate
Random and inherent error; uncontrolled variable
Indeterminate error
Systematic error; flaw in equipment or design of the experiment
Determinate error
Reproducibility of the result
Precision
Other name of relative standard deviation
Coefficient of variation
Difference between the largest and smallest value
Range
Describes how close a measured value is to the “true” value
Accuracy
Difference between the mean value and true value
Absolute error
Absolute error divided by the true value
Relative error
Analytical method in which the volume of a solution of known concentration during analysis is taken as a measure of the amount of active constituent in a sample being analyzed
Titration
3 Titration methods
Volumetric titrations, Gravimetric titrations, Coulometric titrations
Measuring the volume of known concentration needed to react with analyte
Volumetric titrations
Mass instead of volume
Gravimetric titrations
Measure time required for complete electrochemical reaction
Coulometric titrations
Standard solution of known concentration
Titrant
Substance to be determined
Analyte
Added to produce an observable physical change
Indicator
Theoretical point reached when the titrant and analyte are chemically equivalent
Equivalence point/Stoichiometric point
When a physical change occurs that is associated with the condition of chemical equivalence
End point
Weight of the substance chemically equivalent to 1 mL of a standard solution
Titer
Weight of a substance in grams that is chemically equivalent to 1 gram-atom of hydrogen
Gram-Equivalent Weight (GEW)
5 Types of titration
Direct titration, Residual titration, Titration with blank test, Indirect titration, Double residual titration
Titrant is directly added to analyte until the reaction goes to completion
Direct titration
The volume of which that did not react with the analyte is then titrated
Residual/back titration
Sample experimental condition without sample; done to find out the effect of the impurities
Titration with blank test
2 Detection methods
Visual, Instrumental
Appearance/disappearance of color
Visual method
Colorimeters, Turbidimeters, Spectrophotometers
Instrumental method
5 grades of reagent
Technical grade/commercial, USP/NF, Analytical, Chemically pure, Primary standard grade
For general industrial use
Technical grade/commercial
Chemicals manufactured under current GMP and which meet the requirement of USP/NF
USP/NF
High quality chemical for laboratory use
Analytical
Products of purity suitable for use in general applications
Chemically pure
Analytical reagent of exceptional purity that is specially manufactured for standardizing volumetric solutions
Primary standard grade
Determination of exact concentration (normality or molarity) of a solution
Standardization
Highly purified compound; serves as a reference material for titration
Primary standard
Purity has been determined by chemical analysis; serves as the working standard material for titrations
Secondary standard
4 Chemical reactions in titrimetry
Neutralization, Oxidation-reduction, Precipitation, Complexation
Assay of alkaloids
Proximate
Assay of glycosides
Proximate
Assay of morphine
Ultimate
Assay of Ipecac
Proximate
Assay of opium
Proximate
Assay of hyocyamine from belladonna leaf
Ultimate
Assay of volatile oil from caraway oil
Proximate
Assay of total carvone content from an oil
Proximate
Assay of menthol from peppemint
Ultimate
Reading a scale among analysts
Determinate
Electrical noise
Indeterminate
Inability to distinguish color sharply
Indeterminate - Lec
Determinate - Lab
Contamination of precipitates
Determinate
Incorrect sampling
Determinate
Incorrect weights
Determinate
Improper selection of indicators
Determinate