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Stability Conditions Lookup

Look up stability study temperature and humidity conditions from ICH Q1A(R2) and India's New Drugs and Clinical Trials Rules, 2019.

Stability study conditions lookup

Select a source and a product profile to view its published study conditions. No profile is preselected.

The lookup separates ICH Q1A(R2) guidance from India's New Drugs and Clinical Trials Rules, 2019 table.

Container type and intended storage affect which study profile applies.

In short: Choose ICH Q1A(R2) or India’s New Drugs and Clinical Trials (NDCT) Rules, 2019, then choose a product stability profile to view the listed long-term, intermediate and accelerated study conditions. The lookup does not assign a product label storage statement or determine a submission strategy.

What the lookup covers

This tool lists stability study conditions for selected new drug substance and drug product profiles. ICH Q1A(R2) is shown separately from the Indian table in the NDCT Rules, 2019 because the sources have different scope and wording. The current final ICH Q1A harmonised text is Q1A(R2), Step 4 (2003); ICH describes it as recommendations for stability protocols including temperature, humidity and study duration. ICH Quality Guidelines — Q1A(R2) status.

The ICH general-case profiles offer two long-term condition choices: 25°C ± 2°C / 60% RH ± 5% RH or 30°C ± 2°C / 65% RH ± 5% RH. For the first choice, the intermediate condition is 30°C ± 2°C / 65% RH ± 5% RH when called for by significant change at accelerated testing. When 30°C / 65% RH is selected for long-term testing, ICH says there is no intermediate condition. The accelerated condition is 40°C ± 2°C / 75% RH ± 5% RH for six months. ICH Q1A(R2) §§2.1.7.1 and 2.2.7.1.

For an aqueous-based drug product in a semi-permeable container, ICH Q1A(R2) §2.2.7.3 gives a 25°C / 40% RH or 30°C / 35% RH long-term choice and an accelerated condition of 40°C / not more than 25% RH. It calls for assessment of water loss. The tool includes the 30°C / 65% RH intermediate condition only with the cited 25°C / 40% RH profile, and states ICH’s water-loss qualification in the result and reference below.

The India profile is transcribed from the New Drugs and Clinical Trials Rules, 2019 (G.S.R. 227(E), 19 March 2019), Second Schedule, clause 5, as hosted by CDSCO. These rules replaced Schedule Y for new drugs and investigational new drugs for human use (rule 122DAA of the Drugs Rules, 1945, inserted by rule 97 of the NDCT Rules), so the older Schedule Y, Appendix IX table (30°C / 65% RH long term) no longer applies to them. The NDCT general profile lists 30°C ± 2°C / 75% RH ± 5% RH long term for 6 or 12 months and 40°C ± 2°C / 75% RH ± 5% RH accelerated for six months. The refrigerator profile lists 5°C ± 3°C long term (6 or 12 months) and 25°C ± 2°C / 60% RH ± 5% RH accelerated (6 months); the freezer profile lists −20°C ± 5°C long term (6 or 12 months). If significant change occurs during accelerated testing, intermediate testing is called for, but the table gives no intermediate temperature/RH, so the lookup leaves it unstated. CDSCO, New Drugs and Clinical Trials Rules, 2019.

Scope and limitations

  • These are stability study conditions from the cited guidance and rule table, not a direction to label an individual medicine “store at” a particular temperature or humidity.
  • The ICH profiles reflect the scope of ICH Q1A(R2) (2003), which addresses new drug substances and products and notes that it does not necessarily cover other regions’ registration or export requirements. Confirm applicable national or regional requirements for each application.
  • The tool does not select a stability protocol, assess significant change, establish a shelf life, assign storage statements, or cover every dosage form or product type. ICH Q1A(R2) points to separate guidance for new dosage forms and biological products.
  • Below −20°C, the cited ICH text and NDCT Rules clause 5(v) call for case-by-case treatment for their stated scope. No universal condition is inferred here.
  • In-house conditions and acceptance criteria must be set by a site-approved, product-specific protocol. Example in-house criterion (not a pharmacopoeial requirement): an organization may define a more frequent excursion review trigger in its own stability procedure; this example is not a condition supplied by this lookup.

Use the applicable current regulatory source, approved stability protocol and product-specific scientific justification before setting or interpreting study conditions.

References

  • International Council for Harmonisation, Stability Testing of New Drug Substances and Products, ICH Q1A(R2), Step 4 version dated 6 February 2003, §§2.1.7 and 2.2.7. Official ICH PDF. ICH’s official Quality Guidelines page lists Q1A(R2) as the final Step 4 guideline and describes its status.
  • Government of India, Ministry of Health and Family Welfare, New Drugs and Clinical Trials Rules, 2019, G.S.R. 227(E), 19 March 2019, Second Schedule, clause 5 (stability testing of new drug substances and formulations), and rule 97 (rule 122DAA: Part XA and Schedule Y not applicable to new drugs for human use). Official CDSCO PDF.