Forced Degradation Studies

Forced degradation studies are particularly useful in early drug development, providing information on product breakdown and degradation pathways that can improve formulations and assist in determining storage conditions to control product stability. Protheragen-ING Lab specializes in forced degradation studies of pharmaceuticals, which are a key component of drug development and regulatory submissions. Our team of experts is dedicated to providing comprehensive, detailed analyses to ensure the safety, efficacy, and stability of pharmaceutical products throughout their life cycle.

What are drug forced degradation studies?

The purpose of a forced degradation study is to identify and characterize the stability of a drug compound under various stress conditions. The term "stress" refers to any physical or environmental conditions that the drug compound will encounter that may result in chemical changes. This study is essential to understand the inherent stability of a drug and to assess the potential impact of environmental factors such as temperature, humidity, light, and pH on its quality.

Benefits of our testing services

• Establish possible degradation pathways and products.
• Assess the stability of drug compound molecules.
• Validate analytical methods used to assess chemical stability.
• Gain insight into pharmaceutical packaging and storage.

Our drug forced degradation study services

We conduct thorough drug-forced degradation studies of new APIs and pharmaceutical formulations in strict compliance with regulatory guidelines. We use advanced analytical instruments such as LC-MS, GC-MS, and NMR to identify and characterize degradation products to understand degradation pathways. We quantify degradation levels to determine the extent of degradation under different stress conditions, providing valuable insights into drug stability. Based on the results of degradation studies, we provide formulation optimization recommendations to improve drug stability and shelf life.

Fig.1 Illustrative flow chart of various stress conditions for drug substance and drug product degradation^[1].

Our scientists routinely develop and perform forced degradation in the following categories.

• Acid/base stress.
• Base stress.
• Oxidative stress.
• Heat stress (dry and wet).
• Photolytic Stress (ICH Guide Option 2).
• Accelerated Stability (high temperature, high humidity).

Analytical techniques of Protheragen-ING Lab

We can develop, validate, and transfer stability-indicating methods for a wide range of biopharmaceutical products in accordance with ICH guidance. The following analytical techniques can be used to evaluate forced degradation studies:

• Imaging capillary IEF (icIEF) and agarose gel IEF.
• Polyacrylamide gel electrophoresis.
• Capillary Gel Electrophoresis (CGE).
• SEC-MALS.
• Peptide mapping using UV, MS and/or MS/MS and/or MSe analysis.
• UPLC and HPLC.
• MALDI-TOF and ESI-MS.
• Analytical Ultracentrifugation (AUC).
• Dynamic Light Scattering (DLS).
• Circular dichroism (CD).
• Differential Scanning Calorimetry (DSC).
• Extrinsic and Intrinsic Fluorescence.
• Bioassay/BIAcore.
• Fourier Transform Infrared Spectroscopy (FTIR).

Why Choose Protheragen-ING Lab?

• Expertise: Our team consists of experienced scientists with extensive knowledge of pharmaceutical analysis and regulatory requirements.
• Advanced Technology: We utilize cutting-edge analytical instrumentation and methodologies to ensure accurate and reliable results.
• Regulatory Compliance: We adhere to international regulatory guidelines (ICH), to ensure that our studies meet the highest standards of quality and compliance.
• Tailored Solutions: We understand that each drug candidate is unique, and we offer customized study designs to meet the specific needs of our clients.
• Timely Delivery: We prioritize efficiency and strive to deliver results within the agreed-upon timelines, enabling our clients to make informed decisions promptly.

Contact us today to discuss your project requirements and discover how we can assist you in achieving your pharmaceutical development goals.