Pharmaceutical Division Chemistry

ICH Storage Stability

Finished products and sometimes the API (active pharmaceutical ingredient) are placed in storage with specified storage conditions, storage stability is assessed by analysis of  the product at set time points which are detailed in a protocol.

The storage stability protocol is usually written by ILS and sent to the customer for approval before commencing the study. 

Alternatively  the customer will have their own protocol for ILS to follow.

The standard ICH temperatures are:

25°/60%RH - Real time storage condition
30°/65%RH - Intermediate storage condition
40°/75%RH - Accelerated storage condition

ILS have walk-in cabinets at each of these three storage temperatures. ILS also has the option to store at 2 - 8°C if this is to be classed as the real-time storage condition for a product.

All cabinets are monitored 24 hours a day and are alarmed.

ILS do have small spare cabinets in case of breakdowns and also there is some spare capacity in onsite Harlan Laboratories if required.

Typical Testing Time-points for the studies are as follows:

2 – 8 - Initial, 1, 3, 6, 9, 12, 18, 24, 36 months
25/60 - Initial, 1, 3, 6, 9, 12, 18, 24, 36 months
30/65 - Initial, 1, 3, 6, 9, 12
40/75 - Initial, 1, 3, 6

Usually the 30/65 samples are only analysed if there is failure at 40/75. Sometimes storage studies go on for longer than 3 years, but this would just be at the real time storage condition.

If microbial analysis is required then this is usually at the initial time-point and then at the last time-point at each temperature. ILS has an onsite pharmaceutical microbiology department that can undertake this testing.

All methods that are use for a stability study need to be validated to be stability indicating (ie so you will detect any degradation products if present)

Contact ILS - for any further information on ICH storage stability trials