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ICH Q1A(R2) Stability Storage Conditions and Climatic Zones Reference

Choosing the wrong storage condition is a costly mistake because a stability study cannot be repeated quickly. This reference table lists the ICH Q1A(R2) long term, intermediate and accelerated conditions, special cases for refrigerated, frozen and semi-permeable products, and the climatic zones behind them.

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Study type	Product / case	Temperature	Relative humidity	Minimum data at submission	Note
Long term	General drug substance or product	25C +/- 2C	60% RH +/- 5%	12 months	Climatic zones I and II; or alternative below
Long term	General drug substance or product	30C +/- 2C	65% RH +/- 5%	12 months	Alternative long term condition, zones I and II
Long term	General drug substance or product	30C +/- 2C	75% RH +/- 5%	12 months	Zone IVb hot and very humid, per ICH Q1F era practice and WHO
Intermediate	General drug substance or product	30C +/- 2C	65% RH +/- 5%	6 months	Run if significant change occurs at accelerated; not needed if long term is 30C/65%RH
Accelerated	General drug substance or product	40C +/- 2C	75% RH +/- 5%	6 months	Three time points including initial and final, for example 0, 3, 6 months
Long term	Refrigerated product	5C +/- 3C	Not specified	12 months	Store in refrigerator
Accelerated	Refrigerated product	25C +/- 2C	60% RH +/- 5%	6 months	Significant change here needs justification of short excursions
Long term	Frozen product	-20C +/- 5C	Not specified	12 months	Accelerated condition for frozen is case by case, often 5C or 25C
Long term	Semi-permeable container (aqueous solutions)	25C +/- 2C	40% RH +/- 5%	12 months	Water loss assessed; alternative is 30C/35%RH
Long term	Semi-permeable container (aqueous solutions), alternative	30C +/- 2C	35% RH +/- 5%	12 months	Alternative low humidity long term condition
Accelerated	Semi-permeable container (aqueous solutions)	40C +/- 2C	NMT 25% RH	6 months	NMT means not more than
Zone	Climatic zone I	21C mean	45% RH mean	n/a	Temperate
Zone	Climatic zone II	25C mean	60% RH mean	n/a	Subtropical and Mediterranean
Zone	Climatic zone III	30C mean	35% RH mean	n/a	Hot and dry
Zone	Climatic zone IVa	30C mean	65% RH mean	n/a	Hot and humid
Zone	Climatic zone IVb	30C mean	75% RH mean	n/a	Hot and very humid

Based on ICH Q1A(R2) and the WHO climatic zone classification. Zone IVb long term condition is set by WHO and other regional guidance. Confirm the requirement of each regulator and market before finalising a stability protocol. Reference only, not regulatory advice.

Stability program data inside your ERP

An optional outline for tracking stability batches, chambers and pull dates alongside ERP inventory.

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How to use the table

Use the search box to filter by study type, such as Accelerated, or by product case, such as refrigerated. Pick the long term condition from the climatic zone of the markets you ship to, then add accelerated and, if needed, intermediate conditions. Copy the rows you need into your stability protocol and export the table to Excel or PDF. Pair it with the pull schedule worksheet to plan samples.

Where the conditions come from

ICH Q1A(R2) sets the general case: long term at 25C/60%RH or 30C/65%RH, accelerated at 40C/75%RH for six months, and intermediate at 30C/65%RH if significant change occurs in accelerated studies. Significant change includes a 5 percent assay change from initial, failure of acceptance criteria for degradants, appearance, pH or dissolution. Zone IVb markets rely on WHO guidance that sets 30C/75%RH as the long term condition.

Reading the special cases

Products stored in a refrigerator use 5C long term and 25C/60%RH accelerated. Frozen products are studied at minus 20C and the accelerated condition is decided case by case. Aqueous products in semi-permeable containers are tested at low humidity because water loss, not moisture gain, is the risk. A product to be sold in several zones can use the most stringent long term condition to support all of them.

Common mistakes

Frequent errors are using 25C/60%RH for a product intended for zone IVb, forgetting the humidity tolerance, treating chamber excursions as acceptable without assessment and not qualifying chambers for temperature and humidity mapping. Record the chamber ID in the ERP or LIMS sample record so the storage history is traceable.

Frequently Asked Questions

What are the standard ICH stability conditions?

Long term is 25C/60%RH or 30C/65%RH, accelerated is 40C/75%RH for six months, and intermediate is 30C/65%RH when accelerated shows significant change. Refrigerated and frozen products have their own conditions.

Which condition is used for zone IVb markets?

Long term at 30C and 75% RH is commonly required for hot and very humid regions such as parts of Southeast Asia and Africa, following WHO guidance. Check the local authority because requirements differ by country.

What is significant change?

Under ICH Q1A(R2), a significant change for a drug product includes a 5 percent assay change from initial, any degradation product exceeding its acceptance criterion, failure of appearance, physical attributes or pH, or dissolution failure for 12 dosage units.

Is this table enough for a stability protocol?

It is a quick lookup, not a protocol. A protocol also defines batches, container closure, test methods, acceptance criteria, time points, pull windows and the out of trend plan. Confirm each condition with the current guideline.

Netray can help connect stability sample records with ERP inventory and market registration data. This reference is free to use as is.

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