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

> Source: https://netray.co/tools/ich-q1a-stability-storage-conditions-reference
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

A lookup table of ICH stability storage conditions, minimum study durations and climatic zones, filterable by study type and product form.

## Category

quality

## Industry

Pharma and Life Sciences

## Audience

- Stability coordinator
- Regulatory affairs
- QC analyst

## Tool

**Kind:** worksheet

**Mode:** reference

**Columns:**

#### Study type

**Key:** study

**Type:** text

#### Product / case

**Key:** product

**Type:** text

#### Temperature

**Key:** temp

**Type:** text

#### Relative humidity

**Key:** rh

**Type:** text

#### Minimum data at submission

**Key:** min

**Type:** text

#### Note

**Key:** note

**Type:** text

**Rows:**

#### General drug substance or product

**Study:** Long term

**Temp:** 25C +/- 2C

**Rh:** 60% RH +/- 5%

**Min:** 12 months

**Note:** Climatic zones I and II; or alternative below

#### General drug substance or product

**Study:** Long term

**Temp:** 30C +/- 2C

**Rh:** 65% RH +/- 5%

**Min:** 12 months

**Note:** Alternative long term condition, zones I and II

#### General drug substance or product

**Study:** Long term

**Temp:** 30C +/- 2C

**Rh:** 75% RH +/- 5%

**Min:** 12 months

**Note:** Zone IVb hot and very humid, per ICH Q1F era practice and WHO

#### General drug substance or product

**Study:** Intermediate

**Temp:** 30C +/- 2C

**Rh:** 65% RH +/- 5%

**Min:** 6 months

**Note:** Run if significant change occurs at accelerated; not needed if long term is 30C/65%RH

#### General drug substance or product

**Study:** Accelerated

**Temp:** 40C +/- 2C

**Rh:** 75% RH +/- 5%

**Min:** 6 months

**Note:** Three time points including initial and final, for example 0, 3, 6 months

#### Refrigerated product

**Study:** Long term

**Temp:** 5C +/- 3C

**Rh:** Not specified

**Min:** 12 months

**Note:** Store in refrigerator

#### Refrigerated product

**Study:** Accelerated

**Temp:** 25C +/- 2C

**Rh:** 60% RH +/- 5%

**Min:** 6 months

**Note:** Significant change here needs justification of short excursions

#### Frozen product

**Study:** Long term

**Temp:** -20C +/- 5C

**Rh:** Not specified

**Min:** 12 months

**Note:** Accelerated condition for frozen is case by case, often 5C or 25C

#### Semi-permeable container (aqueous solutions)

**Study:** Long term

**Temp:** 25C +/- 2C

**Rh:** 40% RH +/- 5%

**Min:** 12 months

**Note:** Water loss assessed; alternative is 30C/35%RH

#### Semi-permeable container (aqueous solutions), alternative

**Study:** Long term

**Temp:** 30C +/- 2C

**Rh:** 35% RH +/- 5%

**Min:** 12 months

**Note:** Alternative low humidity long term condition

#### Semi-permeable container (aqueous solutions)

**Study:** Accelerated

**Temp:** 40C +/- 2C

**Rh:** NMT 25% RH

**Min:** 6 months

**Note:** NMT means not more than

#### Climatic zone I

**Study:** Zone

**Temp:** 21C mean

**Rh:** 45% RH mean

**Min:** n/a

**Note:** Temperate

#### Climatic zone II

**Study:** Zone

**Temp:** 25C mean

**Rh:** 60% RH mean

**Min:** n/a

**Note:** Subtropical and Mediterranean

#### Climatic zone III

**Study:** Zone

**Temp:** 30C mean

**Rh:** 35% RH mean

**Min:** n/a

**Note:** Hot and dry

#### Climatic zone IVa

**Study:** Zone

**Temp:** 30C mean

**Rh:** 65% RH mean

**Min:** n/a

**Note:** Hot and humid

#### Climatic zone IVb

**Study:** Zone

**Temp:** 30C mean

**Rh:** 75% RH mean

**Min:** n/a

**Note:** Hot and very humid

**Notes:** 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.

## Content

**Intro:** 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.

**Sections:**

#### How to use the table

**Body:** 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

**Body:** 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

**Body:** 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

**Body:** 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.

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

**Faq:**

#### What are the standard ICH stability conditions?

**Answer:** 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?

**Answer:** 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?

**Answer:** 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?

**Answer:** 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.

## Search terms

ICH Q1A storage conditions, stability storage conditions table, climatic zones stability testing, ICH stability conditions zone IVb, 25C 60% RH 40C 75% RH stability, stability chamber conditions, long term accelerated intermediate stability, WHO stability climatic zones

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