PA 1 Flashcards
(39 cards)
What is in the sample?
Qualitative
How much is present in the sample?
Quantitative
Sum of all factors which contribute
directly or indirectly to the safety,
effectiveness, and reliability of the
product
Quality
Ensures that drug products are
designed and produced to meet or
exceed customer requirements for
effect and safety
Quality
Types of analysis
Based on sample size
Based on extent of determination
Based on nature of methods
Total amount of a CLASS or GROUP of active constituents
Proximate
Amount of a SINGLE CHEMICAL SPECIES in a sample
Ultimate
A book of public pharmacopeial
standards
USP/NF
generic or non- proprietary name of the
drug
Official title
a formula which shows the arrangement of the elements
Structural formula
the simplest formula
Empirical formula
overall weight of the compound
Molecular weight
Code numbers assigned by CAS to the chemical substance
Chemical Abstracts Service Number
Include names based on other systems of
nomenclature or naming like IUPAC
Other chemical names
A statement of purity and composition of the compound or drug which has been predetermined by the Pharmacopeia to be the purity
Official definition
the degree to which information
matches true or accepted values
Accuracy
degree to which measurements
fluctuates around a central measurement
Precision
manifest themselves by slight variations in a series of observations
made by the observer under identical conditions
Indeterminate errors
Possible to partially determine their
value and reduce their effect on the
final result
Determinate errors
a method of analysis
that determines the precise endpoint
of a reaction and therefore the
precise quantity of reactant in the
titration flask
Titration
Volumetric or standard solution of known concentration
Titrant
the active constituent to be analyzed
Analyte
Chemicals capable of changing at or near the endpoint
Indicators
Point when added titrant is chemically equivalent to the analyte in the sample
Equivalence point