Hi,
Please refer USP Chapter <1079> “Good Storage and Shipping Practice” in this chapter all are condition mentioned.
Storage statements should be based on the stability evaluations of the Pharmacopeial drug substances and in accordance with national and international requirements.
Room Temperature Storage Statements—
For products with a storage statement reading, “Store at controlled room temperature,” the labeling should read as follows on the package insert: “Store at 20 C to 25 C (68 F to 77 F) excursions permitted between 15 C and 30 C (between 59 F and 86 F). Brief exposure to temperatures up to 40
C (104 F) may be tolerated provided the mean kinetic temperature does not exceed 25 C (77
F); however, such exposure should be minimized.”
On the immediate container label, the following may read for controlled room temperature (CRT): “Store at 20 C to 25 C (68 F to 77 F), excursions permitted between 15 C and 30 C (between 59 F and 86 F).”
Cool Storage Statement—
The storage statement for labeling may be as follows: “Store in a cool place, 8 C to 15 C (46 F to 59 F).”
Refrigerator Storage Statement—The storage statement for labeling may be as follows: “Store in a refrigerator, 2 C to 8 C(36 F to 46 F).”
Freezer Storage Statement—
The storage statement for labeling may be as follows: “Store in a freezer, –25 C to –10 C (–13 F to 14 F).”
See the General Notices for all other applicable storage conditions, such as Storage Under Nonspecific Conditions and store in a Dry Place.
Additional cautionary statements to protect the Pharmacopeial drug product from extreme temperature and humidity conditions may be included on the container label and package insert, as the manufacturer desires.
Thanks,
Kamlesh