Impurity Profiling Services / Structure Elucidation

With expertise in custom synthesis, analytical services, and drug development.
We are here to support all your research needs by reducing the project timeline and cost.

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Our Partners:

Impurity Identification and Quantification

We provide comprehensive impurity identification and quantification services, including:

ARSI Canada
Chromatographic Techniques

Utilizing HPLC, UPLC, and GC to separate and quantify impurities.

ARSI Canada
Mass
Spectrometry

Employing LC-MS/MS and GC-MS for accurate identification and quantification of impurities.

ARSI Canada
Spectroscopic
Techniques

Using NMR and UV-Vis spectroscopy for additional structural information and quantification.

Structure Elucidation

At ARSI Canada, we specialize in structure elucidation and characterization to accelerate drug discovery and development. Using advanced techniques like mass spectrometry, NMR spectroscopy, and X-ray crystallography, our experienced team can precisely identify and confirm the chemical structures of small molecules. This allows for a detailed understanding of a compound’s biological activity, target specificity, and potential interactions with other molecules, ensuring your research is on the right track.

Our comprehensive structure elucidation services provide critical insights into the physicochemical properties of compounds, including solubility, stability, and bioavailability, which are essential for optimizing drug formulations. Whether you’re in the early stages of drug discovery or optimizing lead compounds, ARSI Canada delivers high-quality data and detailed reporting to help you move forward with confidence.

ARSI Canada
NMR Spectroscopy

Provides detailed information about the molecular structure of impurities.

ARSI Canada
Mass Spectrometry

Offers high-resolution mass data to aid in the elucidation of molecular structures.

ARSI Canada
X-Ray Crystallography

Determines the three-dimensional structure of crystalline impurities.

ARSI Canada
FTIR and Raman Spectroscopy

Used for complementary structural information and confirmation of impurity structures.

Degradation Studies

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

ARSI Canada
Stress Testing

Exposing drug substances to stress conditions (heat, light, pH, etc.) to identify degradation products.

ARSI Canada
Stability-Indicating Methods

Developing and validating methods to monitor impurities over the product’s shelf-life.

Residual Solvent Analysis

Our residual solvent analysis ensures that pharmaceutical products comply with regulatory limits for solvents used during manufacturing

ARSI Canada
GC-FID and GC-MS

Techniques used to detect and quantify residual solvents in drug substances and products.

Contract research organization

Why ARSI Canada Inc.?

Choosing ARSI Canada Inc. for your impurity profiling needs means partnering with a team dedicated to delivering excellence. Our robust profiling processes, regulatory expertise, and commitment to quality ensure that your impurity data is reliable and compliant, supporting the successful development and commercialization of your products.

Get in touch with ARSI Canada Inc. for comprehensive impurity profiling services and ensure your drug substances and products meet the highest standards of safety, efficacy, and quality.

FAQs about Impurity Profiling at ARSI Canada Inc.

What is impurity profiling in pharmaceuticals?

Impurity profiling in pharmaceuticals involves identifying, quantifying, and controlling impurities present in drug substances and products. It ensures that pharmaceutical products are safe, effective, and compliant with regulatory standards.

Why is impurity profiling important in drug development?

Impurity profiling is crucial in drug development because it ensures product safety, efficacy, and regulatory compliance. It helps identify and control impurities that could affect the quality and performance of drug products.

What is structure elucidation, and why is it important?

Structure elucidation involves determining the chemical structure of unknown impurities. It is important because it helps in understanding the potential impact of impurities on drug safety and efficacy, and supports regulatory compliance.

What techniques does ARSI use for impurity profiling?

ARSI uses a variety of techniques for impurity profiling, including chromatographic methods (HPLC, UPLC, GC), mass spectrometry (LC-MS/MS, GC-MS), and spectroscopic methods (NMR, UV-Vis, FTIR, Raman spectroscopy).

How does ARSI ensure the accuracy and reliability of impurity profiling?

ARSI ensures the accuracy and reliability of impurity profiling through rigorous method development and validation, advanced analytical technologies, and adherence to regulatory guidelines. Our experienced scientists ensure precise and accurate impurity identification and quantification.

What industries benefit from ARSI's impurity profiling services?

ARSI's impurity profiling services benefit a wide range of industries, including pharmaceuticals, biotechnology, environmental testing, and chemical manufacturing. Our expertise ensures reliable and compliant impurity analysis across various sectors.

How does ARSI handle unknown impurity identification?

ARSI handles unknown impurity identification through advanced techniques such as NMR spectroscopy, mass spectrometry, and x-ray crystallography. These methods provide detailed structural information to accurately identify unknown impurities.

How long does impurity profiling typically take?

The duration of impurity profiling depends on the complexity of the sample and specific project requirements. Typically, it can take several weeks to a few months. ARSI works closely with clients to provide accurate timelines and ensure timely delivery of results.

What documentation is provided after impurity profiling?

After impurity profiling, ARSI provides comprehensive documentation, including detailed impurity profiles, structure elucidation reports, and validation reports. This documentation supports regulatory submissions and quality assurance processes.

How does ARSI ensure regulatory compliance in impurity profiling?

ARSI ensures regulatory compliance in impurity profiling by adhering to guidelines set by the International Council for Harmonisation (ICH), the United States Pharmacopeia (USP), and other relevant regulatory bodies. Our profiling processes meet global regulatory standards.

How can I contact ARSI Canada Inc. for impurity profiling services?

You can contact ARSI Canada Inc. for impurity profiling services by visiting our website and filling out the contact form, or by calling our office directly. Our team is ready to discuss your project needs and provide tailored solutions to support your drug development efforts.

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