Stability studies

Quality Assistance provides offers cGMP stability testing services. 

In order to evaluate the Quality, Safety and Efficacy of the given drugs, Quality Assistance evaluates the physiological characteristics, biological activity and other attributes of the drug product or drug substance accross time and conditions.

Outsource your stability storage to a reliable long-term partner!

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Stability studies

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Our services

ICH compliant stability storage facilities

  • Full compliance with ICH guideline Q1A (R2)

  • Full compliance with cGMP (FDA inspected)

  • Large stability storage facilities

  • Computerised sample flow management

  • 24/7 computerised condition monitoring

  • Back-up storage facilities

  • Back-up electric generators

  • In-house maintenance and qualification teams

  • Secure site (restricted access, alarm systems,etc.)

 

cGMP STABILITY TESTING SERVICES

  • Protocol design and optimisation

  • Development and validation of stability-indicating methods

  • Identification of degradation products

  • Compatibility studies

  • Stability studies

ICH conditions

Other conditions

Ultra-low conditions

-20°C ± 5°C

-30°C ± 5°C

- 60°C ± 10°C

5°C ± 3°C

15 ± 2°C

- 70°C ± 10°C

25 ± 2°C / 40 ± 5% RH

20 ± 2°C

 ≤ - 70°

25 ± 2°C / 60 ± 5% RH

30°C / <40% RH

Vapour phase nitrogen (-196°C)

30 ± 2°C / 65 ± 5% RH

50°C / <40% RH

 

40 ± 2°C / not greater than 25% RH

60 °C / <40% RH

 

40 ± 2°C / 75 ± 5% RH

22,5 ± 2,5°C / 1000 lux ± 400 lux

 

30 ± 2°C / 35 ± 5% RH

-5° C ± 2° C

 

30 ± 2°C / 75 ± 5% RH