What Do 30°C/65% RH and 30°C/75% RH Represent?

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30°C/65% RH: Reflects moderate tropical climates, with temperatures that are warm but not excessively hot and humidity levels that are moderately high.

30°C/75% RH: Simulates more humid conditions often found in tropical or coastal regions where both temperature and humidity are elevated.

Global Regulatory Requirements for Stability Testing

1. United States (FDA)

  • Accelerated Testing: 40°C/75% RH for 6 months
  • Long-Term Testing: 25°C/60% RH

30°C/65% RH and 30°C/75% RH are sometimes used in climate-specific studies to assess how the product might react in moderate or high humidity conditions, particularly for international markets.

2. European Union (EMA)

  • Accelerated Testing: 40°C/75% RH for 6 months
  • Long-Term Testing: 25°C/60% RH for 12 months

For countries with moderate tropical climates (e.g., India, Southeast Asia), 30°C/65% RH is used for extended stability data as a regulatory expectation for long-term studies.

3. India (CDSCO)

  • Accelerated Testing: 40°C/75% RH for 6 months
  • Long-Term Testing: 30°C/65% RH for 12 months

In India, 30°C/65% RH is the most common condition for long-term stability due to the widespread tropical climate in many regions.

4. China (NMPA)

  • Accelerated Testing: 40°C/75% RH for 6 months
  • Long-Term Testing: 25°C/60% RH

30°C/75% RH is used in stability studies for humid regions, especially to assess the impact of moisture on products, particularly those that are sensitive to humidity.

5. Brazil (ANVISA)

  • Accelerated Testing: 40°C/75% RH for 6 months
  • Long-Term Testing: 25°C/60% RH

In Brazil’s hot and humid climate, 30°C/75% RH is commonly used for stability studies of moisture-sensitive products like tablets and capsules.

6. Africa (Various Countries)

  • Accelerated Testing: 40°C/75% RH for 6 months
  • Long-Term Testing: 30°C/65% RH or 30°C/75% RH depending on region-specific conditions

In countries like South Africa, Nigeria, and Kenya, 30°C/75% RH is relevant for tropical climates where both temperature and humidity are high. This condition is used to simulate the stability of products in such environments.

Why These Conditions Matter:

  1. 30°C/65% RH: This is a more moderate condition that simulates regions with tropical but less extreme temperature and humidity fluctuations. Products tested in these conditions are often expected to perform well in mild tropical climates without significant degradation due to moisture absorption or heat.
  2. 30°C/75% RH: This is used to simulate more humid environments, which are common in coastal or tropical areas. Stability testing at these conditions is critical for understanding the impact of moisture on the product, which can lead to degradation, clumping, or changes in drug release rates in moisture-sensitive formulations.


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Resource Person: Dev Soni

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