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