Expiration Dating Flashcards
what is accelerated testing
studies at exaggerated conditions to increase rate of physical and chemical degradation to determine tentative expiration date
what is primary stability data
data on product stored in labeled conditions in the container-closure to be used
what is the expiration date
date product will remain within specifications
what is stability
capacity to remain within specifications
what is supportive data
data other than primary, such as accelerated or literature
what can you predict from accelerated testing arrhenius plot
rate of breakdown at storage conditions - rate constant
what are the axises on an arrhenius plot
log k vs 1/T
what dose forms can not use arrhenius plot to determine stability
solid - experiences moisture changes
suspensions with polymorphic or solvates
materials that will undergo phase changes
materials affect by drop in oxygen or pH change
what must the activation energy be for the accelerated testing to be valid
10-30kcal/mol
what is the analytical method for testing stability
high pressure liquid chromatography
what are the validation criterion for the analytical method
selectivity accuracy linearity sensitivty robustness precision
what is selectivity
ability of method to identify and quantify the analyte in the presence of excipients, degration products, and metabolites
what is accuracy
closeness to the true value
what is the criteria for acceptance of accuracy
recovery values 100 +/- 2% at each concentration
80-120% of target concentration
what is precision
degree of agreement between test results
what is the criteria for precision
minimun 9 determinates
3-5% relative standard deviation
what is linearity
ability of a method to generate test results directly proportional to the concentration of analyte over a given range so plot of response vs concentration will be linear
what is robustness
ability of method to reamin unaffected by small difference in procedure
solid or non aqeous liquid dose forms prepared from commercially available dose form
25% of remaining expiration date of product or 6 months
solid or non aqeous liquid dose forms prepared from bulk ingredients
shortest expiry date of the components or six months
aqeous formulations prepared from solid ingredients (dissolved or suspended)
14 days in the fridge or 30 days if preserved
when can you use literature source expiry date
if published dating is shorter than any of the components used
how are compounded sterile products dated
based on risk level
what sterile products are considered low risk
one dose prepared with comercially made sterile products and devices
what sterile products are medium risk
multiple dose or complex mixtures made from commercial sterile products and devices
what sterile products are high risk
product made using non steril starting material
what is the expiry day of low risk sterile products
room: 48hr
fridge: 14days
freezer: 45 days
what is the expiry date for medium risk sterile products
room: 30 hours
fridge: 7 days
freezer: 45 days
what is the expiry date for high risk sterile compounds
room: 24 hours
fridge: 3 days
freezer: 45 days
what is Q 10
factor the rate constant increases for every 10C increase in temp
what is the assumption when using Q10
Ea is constant
what values can be assigned for Q10
2,3,4
when is the arhenius method not valid
activation energy not between 10-30kcal/mol
rate limited by diffusion or photochemical process
product decomposition due to freezing, agitation, or microbial contamination
what is range
the diff between upper and lower levels of analyte whicah have suitable levels of accuracy and precision
what is sensitivity
lowest concentration where accuracy, linearity, and precision all within acceptable limits
