PA 1 Flashcards
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
Experimental approximate of the
equivalence point
Endpoint
the mathematical formula employed
in the calculation to find the quantity
of the constituent being analyzed
Stoichiometry
grams of substance that is chemically equivalent to 1 mL of a volumetric solution
Titer
a solution whose accurate concentration is known
Standard solution
another standard solution of known concentration
Secondary solution
a carefully weighed sample of a
substance of known concentration
Primary solution
the number of equivalents of solute per liter of solution
Normality
the number of moles of solute per liter of
solution
Molarity
the number of moles of solute per 1000 g of
solvent
Molality
process of establishing the accurate
concentration of a solution by allowing it
to react with a pure substance known as
primary standard
Standardization
acidic titrant with basic analyte
Acidimetry
basic titrant with acidic analyte
Alkalimetry
conducted by introducing a standard acid/ base solution gradually from a buret into a solution of the base/ acid being assayed until chemically
equivalent amounts of each have reacted as shown by some change in properties of the mixture
Direct Titration
carried out by dissolving the substance under
examination in an accurately measured quantity of standard solution known to be in excess and titrating the excess of the latter with another standard solution
Residual Titration
developed by a Danish chemist named Johan Kjeldahl in 1883. This method was specifically developed for determining the
nitrogen contents in organic and inorganic substances
Kjeldahl method
