2 - Expiration Dating Flashcards
Accelerated testing
-these are studies to increase the rate of chemical or physical degradation by using exaggerated storage conditions
What is the purpose of accelerated testing
to determine kinetic parameters in order to predict a tentative expiration dating period
*TO DETERMINE AN EXPIRATION DATE
What is accelerated testing often used synonymously with?
stress testing
*if you want to stress a rxn - add heat
expiration date
date placed on label of drug product that designates date through which the product will remain within specifications
If an expiration date includes only a month and a year, when will the product expire?
the product will meet specifications to the last day of the month
stability
capacity of product to remain within specifications established to ensure its identity, strength (potency), quality and purity
primary stability data
data on product stored under labeled storage conditions in container-closure to be used
supportive stability data
data other than primary stability data such as accelerated studies and published stability data
expiration dates can be predicted by accelerated testing using what equation
Arrhenius plot to predict from high temp data the rate of product breakdown to be expected at actual storage conditions
for what dosage forms is the arrhenius plot quite successful?
solution dosage forms
why is arrhenius plot not so successful for solid dose forms
they will experience changes in moisture which may influence stability
why is arrhenius plot not so successful for suspensions containing polymorphic materials or solvates
they may undergo changes at elevated temperatures
ex. suppositories melt at higher temps
methods valid only when degradation is a thermal phenomenon with an activation energy between _____ kcal/mole
10-30
For drug stability work, method of analysis must be stability-indicating and must be validated: what is the most commonly used method?
high-pressure liquid chromatography
(HPLC)
-separates particles and measures them individually
The analytical method has to have selectivity/ specificity: explain this
-has to have the ability of the method to detect and quantify the analyte in the presence of excipients, degradation products and metabolites
The analytical method has to have accuracy: explain this
closeness of the test result obtained by the method to the true value
Criteria for acceptance of accuracy?
recovery values should be 100 +- 2% at each concentration over the range of 80-120% of the target comparing the measured value to the true value
Precision
degree of agreement among individual test results
Criteria for precision testing?
done by using minimum of nine determinations and the values should not exceed a RSD (relative standard deviation) of 3-5%
Linearity
ability of method to generate test results or responses which directly proportional to the concentration of the analyze within a given range
Robustness
Ability of the method to remain unaffected by small variations in method parameters
Robustness provides an indication of ?
the reliability and durability of the assay
USP 797 is for ?
sterile compounded products
USP 795 is for ?
non-sterile compounded products
