Stressing drug substances or drug products helps to assess their stability.

Forced degradation experiments are a valuable tool to evaluate the stability of a drug substance and understand its potential impact on a drug’s potency and purity as well as on patient safety.

The drug stability guideline Q1A (R2) calls for stress studies on a drug molecule to determine its intrinsic stability characteristics. Such studies allow for the identification of degradation products and are supported by robust analytical procedures at Exova.

The impurity profile of a drug substance, stressed under various conditions, informs analytical method development, aids in defining specifications and assists in the formulation of stable dosage forms.

Exova provides forced degradation and stability studies and assay development services including:

  • Protocol design for degradation studies defined by leading chemists in the field
  • Identification of degradation products supported by state-of-the-art spectroscopy instrumentation, including quadrupole/time of flight tandem mass spectroscopy (Q-TOF) and 500 MHz Nuclear Magnetic Resonance (NMR) equipment
  • Development reports providing a complete history of the forced degradation study design and resulting degradation profiles from all stress conditions
  • A proven track record of successfully developing dozens of stability indicating assays based on degradation data

Exova’s chemists are adept at designing experiments that generate a sufficient degree of degradation so that the profile of degradants is meaningful and quantities generated are in a realistic range for use in creating product specifications.

Our chromatographic specialists develop methods that ensure all degradation products are fully resolved, and a proper mass balance is achieved. They ensure developed methods are optimized to be suitable for finished product application.