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

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

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
/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)
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
container)
MOBILE PHASES and DILUENTS

fulfilled
Organic solvents + water
(e.g. acetonitrile/water, methanol/
water) Depletion
SST criteria must be
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

2 months [1] Visual inspection

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

2SO4 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
1 month

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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

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
Colour change
SOLUTIONS

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]

0.1 M AgNO3 7 months [1]

ARGENTOME

After visual check the

VOLUMETRIC SOLUTIONS(*)

0.01 M AgNO3(**) 5 months [1] Photochemical titre should be

TRY

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

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

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)

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
concentrations
Nicotinamide adenine dinucleotide phosphate
1 year
(NADP) in various concentrations
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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