Freezer— A place in which the temperature is
maintained thermostatically betweeno -25o
and -10o (-13o and 14 F).
Cold— Any temperature not exceeding 8o
(46o F). A refrigerator is a cold place
in which the temperature is maintained
thermostatically between 2o and 8o
(36o and 46o F).
Cool— Any temperature between 8o and 15o
(46o and 59o F). An article
for which storage in a cool place is directed may,
alternatively, be stored and distributed in a
refrigerator, unless otherwise specified by the
individual monograph.
Controlled Cold Temperature— This temperature is
defined as the temperature maintained
thermostatically between 2o and 8o
(36o and 46o F), that allows
for excursions in temperature between 0o
and 15o (32o and 59o
F) that may be experienced during storage, shipping,
and distribution such that the allowable calculated
MKT is not more than 8o (46o
F). Transient spikes up to 25o (77o
F) may be permitted if the manufacturer so instructs
and provided that such spikes do not exceed 24 hours
unless supported by stability data or the
manufacturer instructs otherwise.
Room Temperature— The temperature prevailing in a
working area.
Controlled Room Temperature— A temperature
maintained thermostatically that encompasses the
usual and customary working environment of 20o
to 25o (68o to 77 oF);
that results in a mean kinetic temperature
calculated to be not more than 25o; and
that allows for excursions between 15o
and 30o (59o and 86oF)
that are experienced in pharmacies, hospitals, and
warehouses. Provided the mean kinetic temperature
remains in the allowed range, transient spikes up to
40o are permitted as long as they do not
exceed 24 hours. Spikes above 40o may be
permitted if the manufacturer so instructs. Articles
may be labeled for storage at “controlled room
temperature” or at “up to 25o”, or other
wording based on the same mean kinetic temperature.
The mean kinetic temperature is a calculated value
that may be used as an isothermal storage
temperature that simulates the nonisothermal effects
of storage temperature variations.
An
article for which storage at Controlled Room
Temperature is directed may, alternatively, be
stored and distributed in a cool place, unless
otherwise specified in the individual monograph or
on the label.
Warm— Any temperature between 30o and 40o
(86o and 104o F).
Excessive Heat— Any temperature above 40o
(104o F).
Protection from Freezing— Where, in addition to the
risk of breakage of the container, freezing subjects
an article to loss of strength or potency, or to
destructive alteration of its characteristics, the
container label bears an appropriate instruction to
protect the article from freezing.
Dry Place— The term “dry place” denotes a place that
does not exceed 40% average relative humidity at
Controlled Room Temperature or the equivalent water
vapor pressure at other temperatures. The
determination may be made by direct measurement at
the place or may be based on reported climatic
conditions. Determination is based on not less than
12 equally spaced measurements that encompass either
a season, a year, or, where recorded data
demonstrate, the storage period of the article.
There may be values of up to 45% relative humidity
provided that the average value is 40% relative
humidity.
Storage in a container validated to protect the
article from moisture vapor, including storage
in bulk, is considered a dry place.
