ICH Stability Studies: Storage and Testing Services

Gathering pharmaceutical stability testing data on drug products or drug substances to determine an overall stability profile is a necessary step in the drug approval process. Guidelines for conducting stability studies are described in ICH Q1A(R2) and the ICH stability guidance has been adopted by the European Union, U.S. FDA, and the Japanese Ministry of Health, Labor, and Welfare.

Drug substance, drug product, combination devices, and raw materials need to be assessed for stability. Pacific BioLabs provides stability sample storage and analysis.  The PBL stability chambers are under constant 24 hour and connected to a diesel backup generator in case of emergency power loss.  Your stability studies are given the utmost attention at PBL.

ICH Stability Study Storage Conditions

ICH stability guidelines give storage conditions and times for long-term, intermediate, and accelerated stability studies. Below are the general storage conditions.

  • 25°C and 60% Relative Humidity (RH)
  • 30°C and 65% RH
  • 40°C and 75% RH

In addition to the ICH stability conditions, PBL can provide custom storage conditions (including -80°C and -20°C)as other conditions may also be appropriate. For instance, drug product intended for refrigerated storage would undergo long-term storage at 2-8°C.

ICH Stability Studies: Analysis

PBL is a full service analytical and bioanalytical Bay Area GMP/GLP CRO, and can assess the stability profile of products using numerous analytical techniques: HPLC, LC/MS, and GC among others. Samples are taken at specified time-points and analytically tested to ensure continued viability. For example, a 24 month study, samples are typically tested at 1, 3, 6, 9, 12, 18 and 24 months. In addition analytical analysis of sample, the PBL Microbiology Department can measure sterility, container closure integrity testing, package integrity testing, endotoxin levels, and bioburden on products.

ICH stability data is required as part of an IND or CTA (EU) submission. Since long-term stability studies take 24 months or longer, it is prudent for companies to begin gathering stability data once a suitable drug candidate has been selected.

Stability Study Services Offered

  • Storage:
    • 25°C / 60% Relative Humidity
    • 30°C / 65% RH
    • 40°C / 75% RH
    • Other non-standard temperatures and relative humidity settings
  • Analysis (HPLC, LC/MS, GC)
  • Forced Degradation Studies
    • Photo Stability
    • Oxidation
    • Thermo Stability
  • Sterility / Microbiological Assessment
    • Container Closure Integrity Testing
    • Endotoxin Levels (LAL)
    • Microbial Limits Test (MLT)

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