Expiry Period for Reagents Used in the Laboratories | EDQM

Reagents are an integral part of any laboratory and as such play a vital role in ensuring the validity of analytical results.  Reagents must be suitable for the intended use. 

 

Consideration should be given to the accompanying documentation and appropriate physico-chemical or biological critical quality attributes for the intended purpose/s.

 

In the laboratory, two major types of reagents are generally distinguished: 

• commercial (off-the-shelf, ready to use)
• prepared in the laboratory (inhouse reagents) using the former. 

These two types of reagents are mainly dealt with separately throughout this document.

It should be noted that the principles of FIFO (First In-First Out) or FEFO (First Expired-First Out) should be applied when using reagents.

 

The shelf life for an unopened product or expiry period after first opening is usually set taking into account its stability. 

 

This can be a challenging task because most manufacturers give the shelf life of the unopened product and do not provide information on how long the reagent is stable once the container has been opened.

 

The recommendations for the shelf life of reagent solutions prepared and used in laboratories and presented in this document were established based on scientific data (including validation data obtained from quality control charts, guidelines, standards, pharmacopoeias, publications, etc.) and on the analytical experience and knowledge of OMCLs. 

 

Preparation times, costs, sustainable waste management policies and environmental protection concerns were also considered during the preparation of these recommendations.

 

This document is based on the laboratory experience of the OMCL Network. 

Its purpose is to help maintain the quality of the work carried out in the laboratory on a daily basis and ensure that the results obtained are valid.

 

The recommendations on the shelf life of reagent solutions provided herein should allow laboratories to assess whether a given solution can be used safely and reliably as they take into account various factors that contribute to the degradation of some reagents (temperature, air exposure, moisture, …).

 

For the purpose of this document, the expiry period of a reagent solution should be understood as the period of time during which the reagent is stable and can be used for a given type of analysis. 

 

It should be noted that the same reagent may be unfit for use for some purposes because it has expired, but still suitable for other purposes.

 

Purchase or preparation of reagents and reagent solutions in quantities (volumes) not adapted to current needs should be avoided, as unnecessary disposal that does not take into account the possibility of prolonged use potentially constitutes a direct threat to the environment.

Read also:

• Storage Condition of Pharmaceutical Products
• Different Sampling Strategies in Pharmaceutical Industry

Resource Person: BARBARA PIROLA