Evidence-Based Complementary and Alternative Medicine

Review Article

Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products

Table 3

Storage conditions used for long-term stability testing.


Global community	Testing period (container type)	Storage conditions (temperature/relative humidity, RH)
Global community	Testing period (container type)	In ambient storage	In refrigerator	In freezer

ASEAN [5]	0, 3, 6, 9, 12, 18, 24 months, and annually thereafter	30°C ± 2°C/75% RH ± 5% RH (moisture-permeable container¹) 30°C ± 2°C (moisture-impermeable container²)	5°C ± 3°C	—

EEC [7]	12 months^a (general container) 6 or 12 months^b (general container)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH	5°C ± 3°C	-20°C ± 5°C
EEC [7]	12 months (semipermeable container³)^a 6 or 12 months (semipermeable container)^b	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

EMA [35]	6 or 12 months (general container)	30°C ± 2°C/60% RH ± 5% RH (6 months) 30°C ± 2°C/65% RH ± 5% RH (12 months)	5°C ± 3°C	-20°C ± 5°C
EMA [35]	6 or 12 months (semipermeable container)	25°C ± 2°C/40% RH ± 5% RH (6 months) 30°C ± 2°C/35% RH ± 5% RH (12 months)	—	—

ICH [36]	12 months (general container)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C
ICH [36]	12 months (semipermeable container)	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

WHO [3]	6 or 12 months (general case)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C
WHO [3]	6 or 12 months (semipermeable case)	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

Australia [12]	12 months (general container)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C
Australia [12]	12 months (semipermeable container)	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

Brazil [37]	12 months (impermeable container)	30°C ± 2°C	5°C ± 3°C	−20°C ± 5°C
Brazil [37]	12 months (semipermeable container)	30°C ± 2°C/75% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C

China [17, 18]	0, 3, 6, 9, 12, and 18 months (24 and 36 months, if necessary)	25°C ± 2°C/60% RH ± 10% RH or 30°C ± 2°C/65% RH ± 10% RH	6°C ± 2°C	—

Hong Kong [21]	Every month for 3 consecutive months initially and then every 6 months	25°C ± 2°C/60% RH ± 5% RH	—	—

Japan [24]	12 months (general container)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C
Japan [24]	12 months (semipermeable container)	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

Kenya [25]	12 months (general container)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C
Kenya [25]	12 months (semipermeable container)	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

Korea [27]	0, 3, 6, 9, 12, 18, 24 months, and annually thereafter (general container)	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH	5°C ± 3°C	−20°C ± 5°C
Korea [27]	0, 3, 6, 9, 12, 18, 24 months, and annually thereafter (semipermeable container⁴)	25°C ± 2°C/40% RH ± 5% RH or 30°C ± 2°C/35% RH ± 5% RH	—	—

Philippines [28, 29]	—	30°C ± 2°C/75% RH ± 5% RH	—	—

Zambia [34]	3, 6, 9, 12, 18, 24, and 36 months	25°C ± 2°C/65% RH ± 5% RH	—	—

^aNew medicinal products. ^bMedicinal products manufactured from the existing pharmaceutical substances. ¹Includes polyvinyl chloride (PVC) blisters, low-density polyethylene (LDPE) bottles, and glass or HDPE bottles when fitted with polypropylene closures. ²Includes aluminum/aluminum blisters, high-density polyethylene (HDPE) or glass bottles fitted with metal or HDPE closures. ³Includes plastic bags and soft low-density polyethylene bags for parenteral medicinal products of large volumes, as well as ampoules and vials made of low-density polyethylene. ⁴Includes plastic bags, semisolid low-density polyethylene bags or low-density polyethylene samples, bottles, or vials.