Expiration Dating

Question 1

what is accelerated testing

Answer 1

studies at exaggerated conditions to increase rate of physical and chemical degradation to determine tentative expiration date

Question 2

what is primary stability data

Answer 2

data on product stored in labeled conditions in the container-closure to be used

Question 3

what is the expiration date

Answer 3

date product will remain within specifications

Question 4

what is stability

Answer 4

capacity to remain within specifications

Question 5

what is supportive data

Answer 5

data other than primary, such as accelerated or literature

Question 6

what can you predict from accelerated testing arrhenius plot

Answer 6

rate of breakdown at storage conditions - rate constant

Question 7

what are the axises on an arrhenius plot

Answer 7

log k vs 1/T

Question 8

what dose forms can not use arrhenius plot to determine stability

Answer 8

solid - experiences moisture changes
suspensions with polymorphic or solvates
materials that will undergo phase changes
materials affect by drop in oxygen or pH change

Question 9

what must the activation energy be for the accelerated testing to be valid

Answer 9

10-30kcal/mol

Question 10

what is the analytical method for testing stability

Answer 10

high pressure liquid chromatography

Question 11

what are the validation criterion for the analytical method

Answer 11

selectivity 
accuracy 
linearity
sensitivty 
robustness
precision

Question 12

what is selectivity

Answer 12

ability of method to identify and quantify the analyte in the presence of excipients, degration products, and metabolites

Question 13

what is accuracy

Answer 13

closeness to the true value

Question 14

what is the criteria for acceptance of accuracy

Answer 14

recovery values 100 +/- 2% at each concentration

80-120% of target concentration

Question 15

what is precision

Answer 15

degree of agreement between test results

Question 16

what is the criteria for precision

Answer 16

minimun 9 determinates

3-5% relative standard deviation

Question 17

what is linearity

Answer 17

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

Question 18

what is robustness

Answer 18

ability of method to reamin unaffected by small difference in procedure

Question 19

solid or non aqeous liquid dose forms prepared from commercially available dose form

Answer 19

25% of remaining expiration date of product or 6 months

Question 20

solid or non aqeous liquid dose forms prepared from bulk ingredients

Answer 20

shortest expiry date of the components or six months

Question 21

aqeous formulations prepared from solid ingredients (dissolved or suspended)

Answer 21

14 days in the fridge or 30 days if preserved

Question 22

when can you use literature source expiry date

Answer 22

if published dating is shorter than any of the components used

Question 23

how are compounded sterile products dated

Answer 23

based on risk level

Question 24

what sterile products are considered low risk

Answer 24

one dose prepared with comercially made sterile products and devices

Question 25

what sterile products are medium risk

Answer 25

multiple dose or complex mixtures made from commercial sterile products and devices

Question 26

what sterile products are high risk

Answer 26

product made using non steril starting material

Question 27

what is the expiry day of low risk sterile products

Answer 27

room: 48hr
fridge: 14days
freezer: 45 days

Question 28

what is the expiry date for medium risk sterile products

Answer 28

room: 30 hours
fridge: 7 days
freezer: 45 days

Question 29

what is the expiry date for high risk sterile compounds

Answer 29

room: 24 hours
fridge: 3 days
freezer: 45 days

Question 30

what is Q 10

Answer 30

factor the rate constant increases for every 10C increase in temp

Question 31

what is the assumption when using Q10

Answer 31

Ea is constant

Question 32

what values can be assigned for Q10

Answer 32

2,3,4

Question 33

when is the arhenius method not valid

Answer 33

activation energy not between 10-30kcal/mol
rate limited by diffusion or photochemical process
product decomposition due to freezing, agitation, or microbial contamination

Question 34

what is range

Answer 34

the diff between upper and lower levels of analyte whicah have suitable levels of accuracy and precision

Question 35

what is sensitivity

Answer 35

lowest concentration where accuracy, linearity, and precision all within acceptable limits