Study Set Content:
Not a routine testing method for marketed products.
Cyclic Temperature Stress Testing -
n this method, cyclic temperature stress tests are designed on knowledge of the product so as to mimic likely conditions in
market place storage.
The period of cycle mostly considered is 24 hours since the
diurnal rhythm on earth
The period of cycle mostly considered is 24 hours since the diurnal rhythm on earth is 24 hours, which the marketed pharmaceuticals are most likely to experience during
storage
PROTOCOL FOR STABILITY TESTING
Batches
Containers and Closures
Orientation of storage of containers
Sampling time points
Sampling Plan
Test parameters -
developmental stages are generally carried out on a
single batch
developmental stages are generally carried out on a single batch while studies intended for registration of new product or unstable established product are done on
first three production batches,
developmental stages are generally carried out on a single batch while studies intended for registration of new product or unstable established product are done on first three production batches, while for stable and wellestablished batches, even
two are allowed
testing is done on the product in immediate containers and closures proposed for marketing.
Containers and Closures
samples of the solutions, dispersed systems and semi solid drug products for stability studies must be kept
upright
samples of the solutions, dispersed systems and semi solid drug products for stability studies must be kept upright and positioned either
inverted
samples of the solutions, dispersed systems and semi solid drug products for stability studies must be kept upright and positioned either inverted or on the
side
samples of the solutions, dispersed systems and semi solid drug products for stability studies must be kept upright and positioned either inverted or on the side to allow for full interaction of the product with the
container-closure.
frequency of testing should be such that it is sufficient to establish the stability profile of the new drug substance
Sampling time points
sampling plan for stability testing involves, planning for the number of samples to be charged to the
stability chambers
sampling plan for stability testing involves, planning for the number of samples to be charged to the stability chambers and sampling out of the charged (blank) so as to cover the entire study
batch
he stability test protocol should define the
test parameters
he stability test protocol should define the test parameters that would be used for evaluation of the stability samples. The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as
stability tests
Inherent factors
Solvolysis -
• Oxidation
• Photolysis
• Dehydration
• Racemization
- Materials of high specific area may have cracks and pores that adsorb gases and vapors, such as water, into their interstices.
pore size
