stability testing
- provides evidence on how the quality of a drug substance (DS) or drug product (DP) varies with time under the influence of temperature, humidity, and light.
recommended storage conditions, shelf life, DP & DS specifications
What does stability testing establish?
a
Stability testing is a __________ quality test.
a) primary
b) secondary
c) tertiary
a
Which stability testing is designed to be predictive of the long-term storage conditions?
a) accelerated stability studies
b) long-term studies
c) shelf life
b
Which stability testing establishes the official shelf-life and storage conditions ?
a) accelerated stability studies
b) long-term studies
c) shelf life
c
Which stability testing establishes the time period which a DS or DP is expected to remain?
a) accelerated stability studies
b) long-term studies
c) shelf life
kinetics, MKT, global climate zones, standard testing
What are the 4 principles of stability testing?
hydrolysis, oxidation, photolysis, racemization/epimerization
What are common degradation pathways for pharmaceuticals? (HOPER)
MKT
-single derived temperature which, if maintained over a defined period, gives the same thermal challenge to a pharmaceutical product as would be experienced over a range of both higher and lower temperatures for an equivalent period of time
false
MKT is the average temperature. T/F?
International Council on Harmonization (ICH)
-is a collaborative alliance formed by leading global pharmaceutical regulatory agencies that creates global standard stability testing conditions.
Stability data
-the required data for product approval.
c
What is the minimum length of time required for formal stability data submission?
a) 6 months
b) 9 months
c) 12 months
d) 18 months
3 batches of drug substance, 3 batches of all different configurations, commercial batch size & manufacturing procedure
What kind of data is required for formal stability data submission? (4)
USP 659
Official storage condition statements for the US are published in _______.
20-25 celsius
What is the range for controlled room temperature?
2-8
A refrigerator is a cold place in which temperature is maintained between __________ degrees celsius.
-25 & -10
A freezer is a place where temperature is maintained between __________ degrees celsius.
true
Manufacturers are required to place at least 1 lot of DS and 1 lot of DP of each strength, dosage form and packaging configuration into stability studies each year. T/F?