General European OMCL Network (GEON)

QUALITY MANAGEMENT DOCUMENT

PA/PH/OMCL (21) 60 R2

Recommendations on setting the expiry period for commercial and

in-house-prepared reagents used in the laboratories of the OMCL Network

Full document title Recommendations on setting the expiry period for

and reference commercial and in-house-prepared reagents used in the
laboratories of the OMCL Network, PA/PH/OMCL (21) 60 R2
Document type Recommendation Document

Legislative basis Council Directive 2001/83/EC and 2001/82/EC, as amended

Date of first adoption 31 October 2021

Date of original entry 1 January 2022

into force
Date of entry into
force of revised
document
Previous titles/other N/A
references / last valid
version
Custodian The present document was elaborated by the OMCL Network /
Organisation EDQM of the Council of Europe
Concerned Network GEON

N.B. This OMCL Quality Management System document is applicable to members of the European OMCL
Network only. Other laboratories might use the document on a voluntary basis. However, please note that
the EDQM cannot treat any questions related to the application of the documents submitted by laboratories
other than the OMCLs of the Network.
 PA/PH/OMCL (21) 60 R2 - Recommendations on setting the expiry period for reagents used in the laboratories of the OMCL Network

Table of Contents

Preface ....................................................................................................................................... 3
1. Purpose ............................................................................................................................... 3
2. Scope................................................................................................................................... 4
3. Reagents (chemicals) ........................................................................................................ 4
3.1. Definitions ................................................................................................................... 4
3.2. Establishing shelf life or an expiry date/period for a reagent (ready-to-use) ........... 4
3.2.1. Unopened reagent container .............................................................................. 4
3.2.2. After opening of the reagent container .............................................................. 5
3.3. Decision tree for establishing the expiry period after opening of the reagent .......... 6
4. In-house-prepared reagent solutions ............................................................................... 6
4.1. Quality check .................................................................................................................. 6
4.2. Recommended expiry periods ....................................................................................... 6
4.3. Extension of adopted expiry period .............................................................................. 6
5. Labelling and storage ........................................................................................................ 7
5.1. Examples of annotations for declared storage conditions........................................... 7
6. Conclusions ......................................................................................................................... 7
7. References .......................................................................................................................... 8
Annex 1. ..................................................................................................................................... 9
Annex 2. ....................................................................................................................................10
Annex 3. Risk analysis ..............................................................................................................14

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Preface

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) and those prepared in the laboratory (in-house 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, i.e. how long the quality attributes and chemical integrity of the reagent can be maintained for
the intended analytical application. 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 (provided that the storage conditions comply
with requirements) as they take into account various factors that contribute to the degradation of some
reagents (temperature, air exposure, moisture, etc.).

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. Hence, if prolonging the use of a
given reagent solution for specific purposes is safe and does not compromise the results, such prolongation
should always be considered and justified.

1. Purpose

The aim of this document is to describe and, where possible, define how to set expiry periods for reagents
(chemicals) used in the OMCL Network (and to guide OMCLs in applying them).
It is also intended to provide guidance on regulating the use, labelling, storage and expiry periods of reagent
solutions prepared in OMCLs (in-house solutions) for qualitative, semi-quantitative and quantitative
purposes.

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2. Scope

Use of commercial reagents (chemicals) and reagent solutions prepared in OMCLs within the OMCL Network.

Commercial reagents or reagent preparations for immediate use are out of the scope of this document as
they are not stored and are used within the same day.
In addition, solutions for which there is a certificate by which the traceability to NIST or any other primary
etalon can be established are also out of the scope of this document.

3. Reagents (chemicals)

3.1. Definitions

Reagents
Reagents are solids, gases, liquids or solutions of pure chemical or biological substances, organic
solvents and water.

Quality criteria
Quality criteria are assumed to be covered by appropriate internal standard operating procedures
(SOPs). In general, special consideration should be given to the selection, purchase and receipt of
reagents and their storage. The emphasis is on the crucial step of purchasing reagents of an expected
quality and, upon receipt, on inspection and verification of compliance with the previously set
specifications. These steps precede the labelling and storage of the reagents.

Shelf life of the reagent is a set period or a date given by the manufacturer, which can usually be found
on the certificate of analysis (CoA) for that particular reagent. During this period or until that date, it is
expected that the reagent will meet the quality specifications found in the CoA if the storage conditions
in the material safety data sheet (MSDS) or in any other relevant document, like CoA or label, are
respected.

Reagent without a shelf life or a retest date

Sometimes a shelf life is not defined by the manufacturer because the reagent is considered to have an
extensive shelf life when stored unopened under the proper conditions, or the manufacturer has no
supporting stability data. As the quality of a reagent may be altered due to use (effect of environmental
conditions), setting an expiry date is highly recommended. This can be done, for example, by carrying
out a risk assessment.

Recommended retest date for an unopened reagent

If it is possible to obtain a new certificate from the manufacturer, the shelf life of an unopened reagent
can be extended until a later date.
Expiry period is a period or a specific date after opening of the reagent during which it is expected to
maintain the appropriate physico-chemical or biological critical quality attributes for the intended
purpose, in spite of any physical and chemical changes that may occur. The MSDS should be used as a
guide on how to store the reagent after opening.

Extension of the expiry period for a reagent

The expiry period can be extended following a retest taking into account the critical quality attributes
contributing to the functional characteristics of the reagent, checked by appropriate means or by
scientific judgement.

3.2. Establishing shelf life or an expiry date/period for a reagent (ready-to-use)

3.2.1. Unopened reagent container

Usually a reagent is delivered with a stated shelf life for the unopened container.

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Where no information is available from the manufacturer, the shelf life for unopened reagent containers
can be taken to be the date of receipt plus up to 5 years. This is only applicable if the unopened reagent
container is stored under specified conditions found in relevant documents.

3.2.2. After opening of the reagent container

It is necessary to set a rational expiry period in the absence of analytical data on the stability of the
product after opening. This could be achieved by “real-time monitoring” of the reagent after opening by
gathering experimental analytical data on critical parameters, both chemical and physical, during
laboratory use.

In addition, possible sources of information on the stability of a particular reagent are:

• the CoA or MSDS for the storage conditions and possible instability;
• scientific papers;
• chemical knowledge about the nature of the reagents;
• stability data – additional information from the manufacturer or supplier (e.g. certificates, which
can be found on manufacturers or suppliers website), guidelines, DIN/ISO Standards,
pharmacopoeial texts, etc.

The expiry period after opening should not exceed the shelf life of the unopened reagent container. If it
does, a risk assessment should be done based on the scientific literature and experimental data to show
that use of the reagent after the end of its shelf life does not compromise its safety or the quality of the
measurement results.

Each time a container is opened, the reagent is exposed to various external factors and environmental
conditions that may alter its integrity and affect its quality, which may compromise the validity of the
results.

Reagent properties, storage conditions, handling and the intended use that have to be considered during
the process of establishing the expiry period after opening are:

• Purity of the reagent – this property is very important for establishing the expiry period after
opening. In some cases the higher the purity of the reagent, the shorter the expiry period after
opening. For example, sodium chloride p.a. will have a longer expiry period after opening than
supra-pure sodium chloride, because it is rational to expect that supra-pure solids will
deteriorate more quickly and lose their quality attributes. However, the degree of purity needed
for the testing should be commensurate with the intended use of the reagent: it is important to
select the quality grade that will yield satisfactory results.
• Temperature – should be kept controlled within the range given by the manufacturer/stated in
the MSDS and/or in internal SOPs.
• Humidity – should meet the requirements given by the manufacturer/stated in the MSDS and/or
in internal SOPs.
• Light exposure.
• Contamination during use of the reagent – each time a reagent is opened, accidental
contamination is possible (switching of bottle caps, placing bottle caps on soiled surfaces,
transferring reagents to other containers, use of pipettes for withdrawal, etc.)

It is important to state that, regardless of the expiry period established for the opened reagent, a visual
inspection/examination should be done before use and if any of the physical properties that can be
determined by visual inspection have changed, the reagent should be discarded.

Suggested expiry periods for reagents after opening or for ready-to-use reagent solutions in the absence
of manufacturers' instructions (e.g. certificates) or official regulations (DIN/ISO Standards,
pharmacopoeial texts) or literature data are presented in Annex 1.

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3.3. Decision tree for establishing the expiry period after opening of the reagent

The decision tree presented in Annex 3 demonstrates the decision-making process on how to approach
setting the expiry period after opening.

4. In-house-prepared reagent solutions

Preparation of reagent solutions is carried out in accordance with applicable guidelines, compendial
methods (e.g. pharmacopoeial texts), test method specifications and procedures (Common Technical
Documents [CTDs], SOPs).

4.1. Quality check

It is necessary to ensure that a reagent solution has the properties required for the intended analysis.

Before using prepared reagent solutions, it is strongly recommended to:

• perform a visual inspection – any reagent should be discarded if there is a change in colour or
opalescence, or if there is any precipitation (unless it is necessary),
• perform a pH check before the use of buffer solutions (if applicable),
• determine the titre of volumetric solutions (if applicable),
• perform a Ph. Eur. sensitivity test for indicators.

Perform any other suitable qualification test specific to the prepared reagents. The environmental aspect
must always be taken into account when deciding to shorten the expiry period and/or dispose of a
reagent solution. A solution that is no longer suitable for a given analytical procedure may still be
suitable for another purpose.

4.2. Recommended expiry periods

Consideration should always be given to expiry periods:

• for reagent solutions described in compendial methods (e.g. 2 months for Primary opalescent
suspension in Ph. Eur. chapter 2.2.1);
• provided in drug manufacturers' documentation;
• for reagent solutions for immediate use given in the test method specification, (e.g. data from
the marketing authorisation dossiers).

If no stability data is available, it is recommended to use the expiry periods provided in Annex 2. The
expiry periods presented in Annexes 1 and 2 were established on the basis of the analytical experience
of OMCLs, method validation, guidelines, scientific publications [1, 4] and chemical knowledge.

OMCLs can also perform an in-house validation study to determine the initial expiry date.

4.3. Extension of adopted expiry period

It may be acceptable to extend the expiry periods provided in this document under the following
conditions:

• risk analysis has been performed (see Annex 3);

and/or
• test criteria are established, supporting the extension;
• an in-house validation study to determine the expiry period has been performed.

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The extension of the expiry period and the test criteria should be documented according to internal
OMCL procedures.

5. Labelling and storage

General information on labelling and storage requirements for reagents is given in GL Management of
Reagents, PA/PH/OMCL (11) 157 [3]. Whenever possible, reagent labels should state the expiry period
for an opened container.

More specifically, for reagent solutions:

• reagent solutions should be stored under conditions appropriate for their chemical properties;
• reagent solutions should be stored under the prescribed storage conditions: temperature,
protected from light, protected from moisture;
• reagent solutions should be stored in tightly closed containers;
• containers must be closed immediately after use;
• alkaline solutions should be stored in plastic containers;
• flammable liquids should only be stored in small quantities.

5.1. Examples of annotations for declared storage conditions

• protect from light

• protect from moisture
• use tightly sealed containers (e.g. bottles with lip seals)
• laboratory cabinets
• refrigerator (2 – 8 °C)
• freezer (below – 15 °C)
• under vacuum
• liquid nitrogen storage

6. Conclusions

In this document, general common practices – mainly derived from published literature and real-life
experience – are set out to help OMCL Network members define expiry periods for commercial reagents,
ready-to-use solutions and in-house-prepared reagents.

As shown in Annexes 1 and 2, different expiry periods can be set for the same type of reagent or in-house-
prepared solution depending on their characteristics and purpose.

Most importantly, when setting the expiry date, traceability and quality must be ensured in order to avoid
compromising the final results of the analytical process, meaning the worst-case scenario should be assumed
when setting the expiry period of a reagent after opening.

Under the worst-case scenario, it should not be presumed that the opened reagent can be used after the
expiry date of the unopened reagent unless valid scientific and experimental analytical evidence of its
stability has been provided and a valid risk assessment has been performed.

For in-house-prepared reagent solutions, the expiry period is set mainly taking into account the intended use
of the solution, the purity of the starting reagent, scientific data and any validation data that has been
properly documented and approved.

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Periodic and pre-use quality checks should be conducted regardless of the previously set expiry period both
for opened reagents and for in-house-prepared reagent solutions.

As there are few relevant studies demonstrating stability after opening or stability after preparation of in-
house reagents, caution is required when setting the expiry period as it may compromise the quality of the
final analytical result.

7. References

1. Nogueira JMF, Serôdio P. Determination of the expiration date of chemical solutions. Accred Qual Assur
2003;8:231-4.
2. Barwick V, editor. Eurachem/CITAC Guide: Guide to quality in analytical chemistry: an aid to
accreditation. 3rd edition. 2016. ISBN 978-0-948926-32-7. Available at: https://www.eurachem.org/
3. GL Management of Reagents PA/PH/OMCL 11 (157), EDQM
4. Clontz, L. Quality control systems for the microbiology laboratory. The key to successful inspections. PDA,
Baltimore, Maryland, USA; Davis Horwood International Publishing, Godalming, Surrey, UK, 2000.
5. Bartel, D. Use and storage of chemicals, reagents, reagent solutions, samples, primary and secondary
standards, and laboratory calibration reagents “The PEI approach” Paul-Ehrlich-Institut.
6. DIN/ISO standards (e.g. DIN ISO EN 11732: Water quality: Determination of ammonium nitrogen
method by flow analysis.)

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Annex 1.
Suggested expiry periods for reagents after opening or for ready-to-use reagent solutions in the absence of
manufacturers' instructions (e.g. certificates) or official regulations (DIN/ISO standardspharmacopoeial texts) or
literature data.

Reagent / Reagent Expiry period after

Exceptions Risk analysis
solution opening
Acid and alkaline solutions up to 36 months Shorter expiry period of max. Intake of CO2 or fuming of gases
– inorganic, organic 12 months is recommended changing concentration
for supra-pure and max. 6
months for ultra-pure
solutions after opening
Ammonia solution up to 6 months Depending on the purity: Concentration of ammonia
supra- and ultra-pure – max. decreases with time
1 month
Aqueous salt solutions up to 6 months / Degradation unlikely
Buffer solutions up to 12 months Phosphate buffer – 3 Degradation possible after
months; ready-to-use buffer longer storage, especially for
solutions – manufacturer's buffers with pH > 6;
CoA and discard if turbid Microbiological contamination
Hydrogen peroxide up to 6 months Depending on the purity: Concentration of hydrogen
supra- and ultra-pure – max. peroxide decreases with time
1 month
Indicators – organic, up to 36 months Visual examination before use;
/
inorganic avoid oxidants
Ion-pairs – inorganic, up to 60 months Sodium lauryl sulfonate – Possible disintegration,
organic max. 12 months check with SST
Inorganic reagents – from 12 to 36 months Shorter expiry period of max. Disintegration unlikely (salts,
solids, salts (not 24 months is recommended oxides);
hygroscopic and light- for supra-pure and max. 12 Contamination and/or cross-
degradable salts and months for ultra-pure solids contamination for supra- and
oxides) after opening ultra-pure reagents
Inorganic reagents – Should not exceed expiry Shorter expiry period of max Degradation
solids, salts (hygroscopic date of the unopened 12 months is recommended
and light-degradable salts containers for supra-pure and ultra-pure
and oxides) solids after opening
Liquid media Discard if turbid; Note special preparations Degradation and sweating
Culture media shelf life: up to 6 months possible, depends greatly on the
chemical composition of the
media
Organic reagents – liquids up to 24 months Degradation possible only after
/
longer storage
Organic reagents – solids, up to 36 months Formaldehyde, Degradation and polymerisation
acids, bases Glutaraldehyde, possible
Trifluoroacetic acid – expiry
period max. 12 months
Organic reagents – solids, Should not exceed expiry Shorter expiry period of max. Disintegration
salts (hygroscopic and date of the unopened 12 months is recommended
light-degradable salts and containers for supra- and ultra-pure
oxides) solids after opening

Organic reagents – -solids, from 12 to 36 months Shorter expiry period of max. Contamination and/or cross-
salts (not hygroscopic and 24 months is recommended contamination for supra- and
light-degradable salts and for supra-pure and max. 12 ultra-pure reagents
oxides) months for ultra-pure solids
after opening
Organic solvents from 12 to 36 months Acetone – max. 24 months Degradation or concentration
and Ethanol – max. 36 change due to intake of water
months expiry period after due to humidity
opening; it also depends on
the purity of the reagent: for
sensitive methods like LC-
MS max. 12 months
Sera (animal or human up to 10 years, stored as Modified sera may have a Sublimation and disintegration or
origin) aliquots in air-tight shorter shelf life clotting possible; reduction in
containers at min. −20°C activity possible

REMARKS:
1. Expiry period of the opened container must not exceed the shelf life of the unopened reagent!
2. All proposed periods are based on the experience of OMCLs (exercise performed by OMCLs) and a
document by Detlef Bartel, Paul-Ehrlich-Institut [5].
3. This list is not exhaustive.

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Annex 2.
Table 1. Suggested expiry periods for in-house-prepared reagent solutions used for physico-chemical
tests, established on the basis of the analytical experience of OMCLs, method validation, guidelines and
available literature [1].

REAGENT SOLUTION WITH AN IMPACT ON A RESULT

REAGENT SOLUTION MAXIMUM EXPIRY PERIOD RISK FACTORS RECOMMENDATIONS

Water for chromatography (Ph. Eur.
1095503)
High-purity water
(resistivity [25°C] ≥ 18 MΩ/cm)
rapidly picks up Visual inspection
Water for preparing mobile phases
contaminants
without buffers 24 hours after production
and Discard if turbid
Bacterial
Deionised water
contamination Use from fresh and
(Ph. Eur. 1095508)
(resistivity [25°C] ≥ 18 MΩ/cm) closed containers
WATER

Water, purified SST criteria must be

(Ph. Eur. 04/2018:0008) fulfilled
Bacterial
(conductivity [25°C] 5.1 µS/cm) 3-5 days after production
contamination
Water for preparing buffers, diluents
(solvents), dissolution media
Visual inspection
Water for injections
and
Bacterial Discard if turbid
Sterilised water for injections 2 months after production
contamination
(Ph. Eur. 04/2017:0169)
Use from fresh and
(conductivity [25°C] 1.3 µS/cm)
closed containers
Visual inspection
Pure organic solvent
6 months or original expiry date
(aliquot transferred from the original
(whichever is shorter) SST criteria must be
MOBILE PHASES and DILUENTS

container)
fulfilled
Organic solvents + water
(e.g. acetonitrile/water, methanol/
water) Depletion
SST criteria must be
≥ 50% of organic component 6 months fulfilled
Precipitation

< 50% of organic component 3 months Evaporation of organic

phase
Organic solvent + buffer or buffers
2 weeks
for HPLC
SST criteria must be
Organic solvent + acid/base solution fulfilled
(e.g. phosphoric acid, perchloric pH check (if applicable)
3 months
acid, methanesulfonic acid,
trifluoroacetic acid)

for pH adjustment 12 months

> 0.1 M HCL 7 months [1]

ACID SOLUTIONS

≤ 0.1 M HCL 2 months [1] Visual inspection

Degradation
SST criteria must be
> 0.5 M H2SO4 7 months [1] fulfilled

≤ 0.5 M H2SO4 2 months [1]

Perchloric acid 1 month [1]

ALKALINE SOLUTIONS

For pH adjustment 6 months

Keep in tightly closed
container

0.2 M - 5 M NaOH 5 months [1] Absorbs CO2 Plastic container only

SST criteria must be

fulfilled
≤ 0.1 M NaOH 1 month

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REAGENT SOLUTION WITH AN IMPACT ON A RESULT

REAGENT SOLUTION MAXIMUM EXPIRY PERIOD RISK FACTORS RECOMMENDATIONS

3 months [1]
Ammonia
Oxidation
iron(II) and silver salt solutions 6 months
SOLUTIONS

Colour change
2 M (NH4)(CH3COO) 5 months [1] Visual inspection
SALT

0.1 M NaCl and 5 ppm NaCl 5 months [1] Microbial growth

SST criteria must be
fulfilled
0.1 M Na2SO4 and 10 ppm Na2SO4 5 months [1]
COMPLEXOMETRY

0.1 M EDTA 7.5 months [1]

After visual check the
titre must be
Precipitation determined before use

Plastic container only

0.01 M EDTA(**) 2 months [1]
ARGENTOME

0.1 M AgNO3 7 months [1]

After visual check the
VOLUMETRIC SOLUTIONS(*)

0.01 M AgNO3(**) 5 months [1]

TRY

Photochemical titre should be

degradation determined before use
0.1 M NH4SCN 7 months [1] Protect from light

After visual check the

0.1 M I2 7.5 months [1] titre must be
determined before use
Keep in tightly closed
container
REDOXOMETRY

0.01 M I2(**) 5 months [1] 0.1 M Na2S2O3:

Volatility prepare at least 2
weeks before use
0.1 M Na2S2O3 5 months [1] Air-oxidation
processes
After visual check the
titre must be
determined before use
0.1 M KMnO4 1 month [1]
Prepare at least 2
weeks before use
Filter before use
*
For all volumetric solutions, after visual check the titre must be determined before use and the Ph. Eur. criteria for accuracy
must be fulfilled.
**
Diluted solutions should be preferably prepared for immediate and single use.

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REAGENT SOLUTION WITH AN IMPACT ON A RESULT

REAGENT SOLUTION MAXIMUM EXPIRY PERIOD RISK FACTORS RECOMMENDATIONS

Ferroin 3 years

Phenolphthalein solution 3 years

Perform the sensitivity
test after preparation
NDICATORS

Phenol red solution 3 years and then periodically

(according to Ph. Eur.)

Methylene blue 3 years Visual inspection

Protect from light

Methylthymol blue mixture 2 years

Methyl red solution 3 years

Visual inspection
pH or conductivity
calibration/verification buffers 3 months or original expiry date Absorbs CO2 Keep in tightly closed
(aliquot transferred from the original (whichever is shortest) depending on pH containers
container)
Protect from light

Absorbs CO2
depending on pH Visual inspection
Buffer solutions
Prone to microbial Keep in tightly closed
(others, e.g. ammonium buffer, 2 months
growth depending on containers
acetate buffer)
pH
BUFFER SOLUTIONS

Protect from light

Depletion possible

0.01 M and 0.2 M K2HPO4 1 month and 4 months, respectively [1] Absorbs CO2 Visual inspection
depending on pH
Keep in tightly closed
0.01 M and 1 M KH2PO4 1 month and 4 months, respectively [1]
Prone to microbial containers
0.05 and 0.1 M NaH2PO4 5 months [1] growth, depending on
pH Protect from light
2 M and 0.03 M (NH4)2HPO4 5 months [1]

10% Na2HPO4 1 day [1] Very unstable Prepare fresh

Visual inspection
[0.2% m/v SDS
solution is particularly
SDS buffers or
up to 6 months Precipitation prone to precipitation
other surfactants
depending on the
quality of the starting
reagent]
UREA

Prepare fresh before

Urea solution 1 day
use

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REAGENT SOLUTION WITHOUT AN IMPACT ON A RESULT

REAGENT SOLUTION MAXIMUM EXPIRY PERIOD RISK FACTORS RECOMMENDATIONS
Organic solvents and water used as supplementary solutions (e.g. for flushing columns, cleaning HPLC system)

≥ 50% of organic component 1 year

Visual inspection,
Precipitation
discard if turbid
< 50% of organic component 6 months

Table 2. Suggested expiry periods for in-house solutions, buffers and media used for microbiological tests or
cell cultivation. Established on the basis of analytical experience of OMCLs and available literature [4].

FOR MICROBIOLOGICAL AND CELL-BASED METHODS

REAGENT SOLUTION MAX. EXPIRY PERIOD RECOMMENDATION

Solid or liquid growth media stored in tightly

6 months*
sealed containers (e.g. screw capped flasks)
Below 25°C or 2-8°C depending on the
medium
Solid or liquid growth media stored in unsealed
containers (e.g. bottles with cellulose plug and 1 month
aluminium foil)

BUFFER SOLUTION STORED IN TIGHT CONTAINERS

Solution of 0.2 M potassium dihydrogen
phosphate 6 months Below 25°C
Solution of 0.2 M sodium hydroxide
Buffers prepared from buffer solutions** 1 month Below 25°C
Glucose 6-phosphate solution in various
1 year ≤ − 15°C
concentrations
Nicotinamide adenine dinucleotide phosphate
1 year
(NADP) in various concentrations ≤ − 15°C
Agarose 5% 3 months
RESEARCH ON ANTISEPTICS AND DISINFECTANTS
REAGENT SOLUTION MAX. EXPIRY PERIOD RISK FACTORS/RECOMMENDATION
Below 25°C or 2-8°C depending on the
Neutraliser stored in tightly sealed containers 6 months
composition
Diluent stored in tightly sealed containers 6 months Below 25°C
INTERFERING SUBSTANCE
Bovine albumin 3 g/100 mL 1 month 2-8°C
Bovine albumin + sheep erythrocytes 3 g/100 mL
1 week
+ 3 mL/100 mL 2-8°C
SOLUTIONS TO BE PREPARED IN HARD WATER
Solution A (magnesium chloride and calcium
1 month 2-8°C
chloride)
Solution B (sodium bicarbonate) 1 week 2-8°C
* Growth promotion tests must be performed within three months of the time of use.
** Prepared from sterile solution.

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 PA/PH/OMCL (21) 60 R2 - Recommendations on setting the expiry period for reagents used in the laboratories of the OMCL Network

Annex 3. Risk analysis

A list of questions supporting the risk analysis of a decision on expiry date extension (can be extended
depending on the intended use) of in-house-prepared reagent solutions (open catalogue):

1. Is the reagent solution used:

a. for quantitative purposes?
b. for qualitative purposes?
c. as an auxiliary reagent?
2. Is the reagent prone to:
a. oxidation?
b. hydrolysis?
c. photo- or other degradation?
d. evaporation?
e. pH change (e.g. as a result of CO2 absorption)?
f. microbial growth?
3. Is the reagent solution stored properly?
4. Is the buffering capacity/ion strength important for the purpose of use?
5. Is the pH of the solution important for the purpose of use?
6. Is the exact concentration of the solution important for the purpose of use?
7. Was the reagent solution prepared in a sterile manner?
8. Is the reagent solution used in a way that preserves sterility?
9. Is sterility important for the intended use?
10. Can the reagent solution attributes be easily verified/controlled before use (e.g. pH check,
osmolality, absorbance)?
11. Will control tests be performed during the use of the reagent solution that will allow its suitability to
be verified?
12. Are the SST criteria fulfilled while the reagent solution is used?
13. Purity of the reagent?

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 PA/PH/OMCL (21) 60 R2 - Recommendations on setting the expiry period for reagents used in the laboratories of the OMCL Network

Figure 1. Graphical representation of the decision-making process for determining the expiry period of a
reagent after opening.

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