[ORAL EXAM] Pharm Analysis Flashcards
Concerned with either the identification or quantification of one or more substances in a given sample of pharm interest
Pharmaceutical Analysis
Reveals the identification of an element or compound in a sample
Identification
The totality of characteristics or features of a product that bear on its capacity to satisfy stated or implied needs
Quality
Determination and exact amount of an exact analyte
Quantification
Responsible for operation and process
Quality Assurance
Sum total of 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, specification, testing, organization, documentation
Quality Control
Responsible for testing and sampling of the drug products
Quality Control
Process Oriented
Quality Assurance
Product Oriented
Quality Control
Document that contains a list of tests, references to analytical procedures and appropriate acceptance criteria
Specification
A written standard that describes an article like a drug substance, drug product, excipients or compounded preparation
Monograph
A collection of data gathered and presented in the form of a book
Compendia
Universal Tests: Appearance Testing
Description
less than 1mg
Ultra Microanalysis
Universal Tests: Threshold presence of related degradation substances in the drug sample
Impurities
Universal Tests: Quantitative measure of compound in a sample
Assay
100ppm - 1000ppm
Trace Analysis
1mg - 10mg
Micro Analysis
Universal Tests: Verification of Identity
Identification
10mg-100mg
Semi-Microanalysis
100mg+
Macroanalysis
Nature of method based on chemical reactions
Classical Methods
Total amount of a single and specific compound
Ultimate analysis
Total amount of a group or class of compounds
Proximate analysis
Nature of method based on physical and chemical properties of analyte
Instrumental Methods
Nature of method that deals with crude drugs or natural products
Miscellaneous/Special Methods
Aka Accuracy
Trueness
Error in analysis
Accuracy
Closeness of an actual value to the theoretical/true value
Accuracy
Closeness of an actual value of 2 or more test results to each other
Precision
Precision under the same laboratory but with different analysts
Intermediate
Within-Laboratory
Precision under the same operating conditions in a short period of time
Repeatability
Intra-assay
Due to factors external to the method
Ruggedness