Element conducts forced degradation studies and stress testing in compliance with the drug stability guideline Q1A (R2) to assess drug substances or drug products’ 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 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.
Element provides forced degradation and stability studies as well as assay development services to assess the purity profile and behavior of a drug substance under various environmental conditions.
Forced degradation assay development services
- 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 quadruple/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
Forced degradation ICH guidelines – Q1A (RA)
At Element, we follow the drug stability guideline Q1A (R2), which involves stress studies on a drug molecule to determine its intrinsic stability characteristics and allows for the identification of degradation products.
Our Engaged Experts support stress studies by robust analytical procedures to determine the stability of molecule and help you select proper formulation and package, and provide suitable storage conditions and shelf life for your drug products and drug substances.
The Element advantage
Element'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.
For more information about our forced degradation studies or to request a quote, contact us today.
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Element provides innovative analytical method development and validation solutions to regulatory guidelines for a wide range of analytical technologies.
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