Pharm Analysis Quiz Flashcards
Concerned with either the identification or quantification of one or more
substances in a given sample of pharmaceutical interest
Pharmaceutical Analysis
The totality of characteristics or features of a product that bear on its
capacity to satisfy stated or implied needs
Quality
How much it? –refers to
Quantification
What is it? – refers to
Identification
The sum total of the organized
arrangements made with the
objective of ensuring that products
are of the quality required for their
intended use
Quality Assurance
Part of CGMP concerned with
sampling, specifications, testing,
organization, documentation and
release procedures
Quality Control
product oriented
Quality Control
process oriented
Quality Assurance
sample testing and specifications
Quality Control
audit and monitoring
Quality Assurance
Document that contains a list of tests, references to analytical procedures and appropriate acceptance criteria
Specifications
A collection of data gathered and presented in the form
of a book
Compendia
A written standard that describes an article like a drug
substance, drug product, excipients or compounded
preparation
Monograph
UNIVERSAL TESTS: Appearance testing
Description
UNIVERSAL TESTS:Verification of identity
Identification
UNIVERSAL TESTS:Threshold presence of related degradation
substances in the drug sample
Impurities
less than 1mg
Ultra Microanalysis
UNIVERSAL TESTS:Quantitative measure of compound in a sample
Assay
100-1000ppm
Trace Analysis
more than 100mg
Macroanalysis
based on physical and chemical properties of analyte
Instrumental Methods
1mg -10mg
Micro Analysis
10mg - 100mg
Semi-Micro Analysis
total amount of a group or class of compounds
Proximate Analysis
AKA of Accuracy
Trueness
total amount of a single, specific compound
UltimateAnalysis
based on chemical reactions (stoichiometric)
Classical Methods
The closeness of the actual value of 2 or more test results to each other
Precision
deals with crude drugs or natural products
Miscellaneous/Special Method
precision under the same
operating conditions over a
short period of time
REPEATABILITY or Intra-assay
precision under the same
laboratory but with
different analysts,
apparatuses, and days
INTERMEDIATE or Within Laboratory
Expresses the closeness of an actual value to the theoretical/true value
Accuracy
express variation between
laboratories
REPRODUCIBILITY or Inter-laboratory
A measure of capacity to remain unaffected by deliberate variations in
method
Robustness or Ruggedness
Robustness or Ruggedness: is due to factors external to the method
Ruggedness
Ability to assess the analyte in the presence of other substances
Specificity
Robustness or Ruggedness: is due to factors internal to the method
Robustness
Defined as the difference in the numerical values between a measured
value and the true value.
Error
Ability to obtain result of variable data which is directly proportional to the
concentration in the sample.
Linearity
Ability to discriminate between small differences in analyte concentration
Sensitivity
Aka: Indeterminate Error
Random Error
It is referred as the SLOPE OF CALLIBRATION CURVE
Sensitivity
Aka: Determinate Error
Systematic Error
Error that affects Precision
Random Error
Error that affects accuracy
Systematic Error
AKA: CLASSICAL METHODS
TITRIMETRY
Entire procedure is repeated except that the analyte is omitted
Blank Titration
Complex organic compounds capable of
changing colors which aid in the
visualization of the endpoint
INDICATOR
Involves a solution of reagent of known concentration added to a solution
of analyte until reaction is judged complete
TITRIMETRY
Reagent or solution of known concentration
AKA: Standard Solution or Volumetric Solution
TITRANT
Compound with unknown concentration
AKA: ANALYTE OR SAMPLE
TITRAND
Process of determining the exact concentration of a titrant/standard solution
Standardization
Substance of high degree of purity
PRIMARY STANDARD
Prepared from primary standard
SECONDARY STANDARD
