Case Study Conditions
General Long term2

Intermediate 2

 

Accelerated

25 °C ± 2 °C/60%
RH ± 5% RH; or
30 °C ± 2 °C/65%
RH ± 5% RH;
30 °C ± 2 °C/65%
RH ± 5% RH
40 °C ± 2 °C/75%
RH ± 5% RH
Stored in
refrigerator
Long term
Intermediate
5 °C ± 3 °C
25 °C ± 2 °C/60%
RH ± 5% RH
Stored in
freezer
Long term -20 °C ± 5 °C

 

LLC Lab can offer consulting service to clients for testing of various range of stability conditions, including the most commonly used: 5 ±3°C, 25°C/60%, 30°C/65%RH, and 40°C/75%RH. We can develop stability programs and support clients to conduct the stability studies as well as forced degradation studies at any stage of the product development in compliance with ICH, US-FDA, and Health Canada regulatory requirements. Following support services for stability studies  and consultancy we can offer-

  • Stability Protocol Design and execution
  • Forced degradation studies protocol design and execution
  • Development and validation of “stability indicating methods
  • Long term stability studies
  • Intermediate stability studies
  • Accelerated stability studies
  • Photo-stability studies
  • Customized condition stability studies
  • Formulation evaluation stability studies
  • Stability testing for R&D stages of IND, NDA and ANDA
  • Commercial/post market stability studies
  • Transportation related stability study including simulation study
  • During transportation, freeze/thaw study, and cycle test, in-use study, etc.
  • Stability trends to compare different packaging materials and Container closure system study design and its impact on product stability.
  • Customized data recording, reporting and trending, including-
  • Trending  report of OOT and OOS data
  • Stability  studies summary report preparation