Stability Flashcards
what is drug stability
extent a product retains the same properties and characteristics ti possessed at time of manufacture
what are 3 areas of concern for drug stability
chemical
physical
sterility
degradation of the active may result in ?
inaccuracy in dosin
what are the 5 ways of chemical degradation
hydrolysis oxidation photolysis racemization dehydration
what is hydrolysis
decomposition of drug through reaction with water
what is the most common functional group involved?
carboxyl derivatives
what are the functional groups subject to hydrolysis
amide - acetaminophen lactam- penicillin ester-atropine lactone-warfarin acetal- erythromycin imine- diazepam
how are drugs degraded by oxidation
spontaneously atmospheric oxygen is added or loss of hydrogen
how are the products of oxidation different
more conjugated
color/aroma changes
what are the functional groups subject to oxidation
phenol-steroid catchol-isoproterenol ether- PEG thiol- methimazole thioether-chlopromazine aldehyde-paraldehyde
how does photolysis degrade drugs
light provides energy for initiation of oxidative process
what are the four things that may occur when electromagnetic radiation is absorbed by a molecule
molecule decomposes
energy retained =chemical change
energy converted to heat
emit light of diff wavelength
how does dehydration change drug stability
loss of water molecule changes the crystal habit (pseudopolymorphism) which may change solubility
what is racemization
change in optical activity - changes biological activity
what forms a schiff base
primary amine and aldehyde functional groups
what forms a maillard reaction
amine and hydroxyl group