Page 171 - Applied Pharmacognosy

Types of Chemical markers

frequency of testing should be sufficient to establish the stability profile of the
active substance. The frequency of testing at the long term storage condition
should normally be every 3 months over the first year, every 6 months over the
second year, and annually thereafter through the proposed re-test period.

• At the accelerated storage condition,

a minimum of three points, including the initial and final time points (e.g., 0, 3,
and 6 months), from a 6-month study is recommended. Where an expectation
(based on development experience) exists that results from accelerated studies
are likely to approach significant change criteria, increased testing should be
conducted either by adding samples at the final time point or by including a
fourth time point in the study design.