Introduction on Temperature conditions according to different Pharmacopoeias:-
All the drugs and drugs products are manufactured by
using the organic or inorganic components i.e Active material, excipients etc.
We know based on temperature and humidity conditions, the nature of drug
molecules getting changed. Hence it is necessary to keep the drugs or drug
products on suitable temperature and humidity to maintain durability of that
product. Based on storage condition the self-life of drug product changed.
Hence the storage condition plays a major role to give consistent performance
of respective drug product.
According to different Pharmacopoeias the storage
conditions are defined and classified according to temperature range. The
respective pharmacopoeias Instructed to keep the drug product or Pharmacopoeias
article in given storage conditions to avoid any contamination,
deterioration. Below are the storage
conditions classifications are mentioned according to different pharmacopoeia.
According to Indian Pharmacopoeia, the storage conditions are defined by
the following terms:
·
Store
in a dry, well-ventilated place at a temperature not exceeding 30°C.
·
Store
in a refrigerator (2°C to 8°C). Do not freeze.
·
Store
in a freezer (-2°C to -18°C).
·
Store
in a deep freezer (Below -18°C).
Whenever
for Pharmacopoeial article/ drug product mentioned as “Store protect from
light, or Store protected from light and moisture” in that case temperature
condition not applies.
According
to Unites
State Pharmacopoeias, the temperature and storage condition for drug
articles are defined in General Chapter <659>. The temperature and
storage condition classifications are as below:-
Controlled Room Temperature: The
temperature maintained thermostatically that covers the normal working
environment of 20°C–25°C (68°F–77° F).
The
following conditions also apply if Mean kinetic temperature not to exceed 25°C.
Excursions between 15°C and 30°C (59° and 86° F) that are experienced in
pharmacies, hospitals, and warehouses, and during shipping are allowed.
Provided the mean kinetic temperature does not exceed 25°C, transient spikes up
to 40°C are permitted as long as they do not exceed 24 h. Spikes above 40°C may
be permitted only if the manufacturer so instructs.
Room Temperature: The room temperature also referred as
ambient temperature. It means the temperature usually in a working environment
considered as room temperature of ambient temperature.
Cool: Any temperature between 8°C to 15°C
(46° and 59° F).
Cold: Any temperature not exceeding 8°C (46°
F).
Refrigerator: A cold place in which the temperature
is controlled between 2°C and 8°C (36° and 46° F).
Freezer: A place in which the temperature is
controlled between −25°C and −10°C (−13° and 14° F).
Warm: Any temperature between 30°C and 40°C
(86° and 104° F).
Excessive heat: Any temperature above 40° (104° F).
Dry place: A place that does not exceed 40%
average relative humidity at 20°C (68° F) or the equivalent water vapor
pressure at other temperatures.
The European Pharmacopoeia (Ph. Eur.) sets specific temperature conditions for various
pharmaceutical products to ensure their quality, stability, and efficacy. These
conditions are designed to maintain the integrity and effectiveness of the
pharmaceuticals during storage and transportation. Here are some common
temperature conditions outlined by the European Pharmacopoeia:
Controlled
room Temperature: Not
exceeding 25°C
Refrigerated:
Between 2°C and 8°C
Freezer: Between -15°C and -25°C
Deep
freezer: Below -20°C
According to Japanese Pharmacopoeia the temperature conditions are mentioned in
General Notices-5. In Japanese Pharmacopoeia the terminologies for temperature
conditions are mentioned as below:
Standard
Temperature: 20°C
Ordinary
Temperature: 15°C to
25°C
Room
Temperature: 1°C to
30°C
Lukewarm
Temperature: 30°C to 40°C.
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Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.