Forced Degradation Study (or Stress Testing) typically involves 1[the] Exposure of Drug Substances or Formulations thereof to Environmental Stress Conditions namely Heat and Humidity and Light for Solid-State Studies. For Liquid State Studies2[,] the Drug Substance/Formulation is exposed to a range of pH values, Freezing and Thawing. It is also referred as Accelerated Stability Study.
Degradation Type
|
Experimental Conditions
|
Condition
|
Acid
|
0.1 N Hydrochloric Acid
|
Ambient
|
Base
|
0.1 N NaOH
|
Ambient
|
Oxidation
|
3 % Hydrogen Peroxide
|
Ambient
|
Photolysis
|
UV Lamp
|
Ambient
|
Thermal
|
Heat Chamber
|
60°C
|
Metal Ions
|
0.05 M Fe2 or Cu2
|
Ambient
|
Humidity
|
Stability Chamber
|
75 % RH or Greater
|
Forced Degradation
In ICH Q1A, Section 2.1.2 (Stress Testing), there are recommended Conditions [Conditions have been recommended] for performing Forced Degradation Studies on Drug Substances (API) and Drug Products (Formulations).
In ICH Q1A, Section 2.1.2 (Stress Testing), 1there are recommended Conditions [Conditions have been recommended] for performing Forced Degradation Studies on Drug Substances (API) and Drug Products (Formulations).
The Recommendations 2are to examine [for the examination of] the Effects of Temperature (above that for Accelerated Testing, i.e., >50°C), Humidity (≥75% Relative Humidity), Oxidation & Photolysis.
ICH Q1B 3gives recommended [recommends] approaches to assess the 4Photo stability [Photostability] of Drug Substances and Drug Products. Forced Degradation Conditions are specified in Section II (Drug Substance) and Section III (Drug Product). 5Photo stability [Photostability] Testing can be performed on the Solid or in Solution/ Suspension.
EFRAC has proven Competency and Adequate Capacity to undertake all such Degradation Studies across Various Drug Matrices. 6At EFRAC the [EFRACs] dedicated analytical team is equipped with the 7necessity [necessary] state-of-the-art facilities and technical expertise to ensure complete Drug safety for future generations.