Introduction to Forced Degradation Studies

At ARSI Canada Inc., we offer comprehensive forced degradation studies designed to assess the stability and degradation pathways of drug substances and products.
Forced degradation studies involve subjecting samples to stress conditions such as heat, light, humidity, and acidic or alkaline pH to accelerate degradation
processes and identify potential degradation products.

Importance of Forced Degradation Studies

Forced degradation studies play a critical role in pharmaceutical development and regulatory submissions:

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Stability Assessment

Provides crucial data on the stability of drug substances and products under various stress conditions, guiding formulation development and shelf-life determination.

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Degradation Pathway Identification

Helps identify degradation pathways and potential degradation products, enabling the development of robust formulations and manufacturing processes.

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Regulatory Compliance

Supports regulatory submissions by demonstrating product stability, ensuring compliance with regulatory guidelines (e.g., ICH Q1A), and justifying proposed storage conditions and shelf-life specifications.

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Risk Assessment

Facilitates risk assessment by identifying potential degradation-related risks and enabling the implementation of appropriate mitigation strategies.

Why Choose ARSI for Forced Degradation Studies?

ARSI Canada Inc. is your trusted partner for forced degradation studies, offering:

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Experienced Scientists

Our team of scientists has extensive expertise in forced degradation studies and stability testing.

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Advanced Technology

We utilize state-of-the-art instrumentation and techniques to conduct forced degradation studies with precision and accuracy.

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Regulatory Expertise

We are well-versed in global regulatory requirements, ensuring that our studies meet the highest standards of quality and compliance.

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Comprehensive Reporting

We provide detailed reports summarizing study findings, degradation pathways, and recommendations for formulation optimization and stability testing.

Forced Degradation Studies Services

We conduct degradation studies to understand the stability of drug substances and products, identifying potential degradation products and their impact

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Stress Testing

We conduct stress testing studies to evaluate the stability of drug substances and products under various stress conditions, including:

Temperature: Exposing samples to elevated temperatures to accelerate degradation reactions
Light: Subjecting samples to light exposure to assess photostability and photo-degradation.
pH: Testing samples under acidic or alkaline conditions to evaluate pH-dependent stability.
Oxidation: Assessing the susceptibility of samples to oxidation reactions by exposing them to oxidizing agents.

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Degradation Product Identification

We identify and characterize degradation products using advanced analytical techniques, including:

Chromatography: Utilizing HPLC, UPLC, and GC for separation and quantification of degradation products.
Mass Spectrometry: Employing LC-MS/MS and GC-MS for accurate identification and structural elucidation of degradation products.
Spectroscopy: Using FTIR, UV-Vis, and NMR spectroscopy for additional structural information and confirmation of degradation product identities.

Contract Research Organization

Why ARSI Canada Inc.?

Choosing ARSI Canada Inc. for your forced degradation study needs means partnering with a team dedicated to delivering accurate, reliable, and actionable data. Our experienced scientists, advanced instrumentation, regulatory expertise, and comprehensive reporting ensure that your forced degradation studies are conducted with precision and expertise, supporting your drug development and regulatory submission requirements.

Get in touch with ARSI Canada Inc. for comprehensive forced degradation study services and ensure the stability and safety of your drug substances and products.

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