Escolar Documentos
Profissional Documentos
Cultura Documentos
Storage Condition
Long term
30oC 2oC/75% RH
5% RH
Minimum Time
Period Covered by
Data at Submission
6 months
12 months
Accelerated
40oC 2oC/75% RH
5% RH
6 months
Number of Batches
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Storage Condition
Long term
30oC 2oC/75% RH
5% RH
Accelerated
40oC 2oC/75% RH
5% RH
Minimum Time
Period Covered by
Data at Submission
6 months
6 months
Number of Batches
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
10
5th Draft
Storage Condition
Long term
30oC 2oC/75% RH
5% RH
Minimum Time
Period Covered by
Data at Submission
3 months*
6 months
Accelerated
40oC 2oC/75% RH
5% RH
3 months*
6 months
Number of Batches
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
4.8.
In-use Stability
i.
The purpose of in-use stability testing is to provide information for the labelling on
the preparation, storage conditions and utilization period of multidose products
after opening, reconstitution or dilution of a solution, e.g. an antibiotic injection
supplied as a powder for reconstitution.
ii. As far as possible the test should be designed to simulate the use of the drug
product in practice, taking into consideration the filling volume of the container
and any dilution or reconstitution before use. At intervals comparable to those
which occur in practice appropriate quantities should be removed by the
withdrawal methods normally used and described in the product literature.
iii. The physical, chemical and microbial properties of the drug product susceptible to
change during storage should be determined over the period of the proposed in-use
shelf-life. If possible, testing should be performed at intermediate time points and
at the end of the proposed in-use shelf-life on the final amount of the drug
remaining in the container. Specific parameters, e.g. for liquids and semi-solids,
preservatives, per content and effectiveness, need to be studied.
iv. A minimum of two batches, at least pilot-scale batches, should be subjected to the
test. At least one of these batches should be chosen towards the end of its shelf11