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Introduction to Method Development
At ARSI Canada Inc., we specialize in providing comprehensive method development services
tailored to the pharmaceutical and biotechnology industries. Our state-of-the-art facilities and
expert team ensure that every analytical method we develop is robust, reliable, and compliant
with regulatory standards.
Importance of Method Development
Whether you are in the early stages of drug discovery or advancing through the development process, our method development services provide the foundation for accurate and consistent results. Method development is a critical component of the drug development process. Accurate and reliable analytical methods are essential for:
- Ensuring Quality Control: Consistent product quality and safety.
- Regulatory Compliance: Meeting stringent regulatory requirements.
- Optimizing Formulations: Enhancing drug efficacy and stability.
- Accelerating Time-to-Market: Streamlining the development process for quicker
market entry.
Customized Chromatographic Methods
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High-Performance Liquid Chromatography (HPLC) is vital for accurate analysis. Our HPLC method development services include:
- Quantification of APIs: Accurate measurement of active pharmaceutical ingredients (APIs) in various formulations.
- Impurity Profiling: Identification and quantification of impurities anddegradation products to ensure product safety and efficacy.
- Dissolution Testing: Custom HPLC methods for evaluating the release profiles of solid oral dosage forms.
Gas Chromatography (GC) is crucial for analyzing volatile compounds. Our GC method development services include:
- Residual Solvent Analysis: Detection and quantification of residual solvents in pharmaceuticals.
- Volatile Organic Compounds (VOCs): Analysis of VOCs in
environmental samples, food products, and packaging materials.
- Flavor and Fragrance Analysis: Profiling flavors and fragrances in food and cosmetic products.
Spectroscopic Method Development
Nuclear Magnetic Resonance (NMR) spectroscopy is essential for detailed structural analysis. Our NMR method development services include:
- Structural Elucidation: Detailed molecular structure analysis of APIs and excipients.
- Polymorph Identification: Identifying and characterizing different polymorphic forms of drug substances.
UV-Visible (UV-Vis) spectroscopy is used for concentration and purity assessments. Our UV-Vis method development services include:
- Concentration and Purity: Determining the concentration and purity of proteins, nucleic acids, and other biologics.
- Antioxidant Capacity: Evaluating the antioxidant capacity of food supplements and nutraceuticals.
Liquid Chromatography-Mass Spectrometry (LC-MS/MS) combines separation and detection for complex analyses. Our LC-MS/MS method development services include:
- Pharmacokinetic Studies: Quantifying drugs and metabolites in biological matrices.
- Biomarker Analysis: Identifying and quantifying biomarkers in clinical research.
- Impurity Detection: Detecting and quantifying impurities and
degradation products.
Gas Chromatography-Mass Spectrometry (GC-MS) is ideal for volatile and semi-volatile compounds. Our GC-MS method development services include:
- Environmental Analysis: Analyzing pollutants and contaminants in environmental samples.
- Food Safety: Detecting pesticides, herbicides, and contaminants in food products.
- Forensic Analysis: Identifying and quantifying drugs of abuse and toxic substances.
Formulation related method developments
- Laser Diffraction Analysis: Methods for analyzing particle size distribution in powders, granules, and emulsions.
- Dynamic Light Scattering (DLS): Size distribution of nanoparticles and colloids in liquid formulations.
- X-ray Powder Diffraction (XRPD): Identifying and quantifying polymorphic forms of APIs.
- Differential Scanning Calorimetry (DSC): Analyzing thermal properties of different polymorphs and excipients.
Why ARSI Canada Inc.?
At ARSI Canada Inc., we are committed to delivering excellence in method development. Our experienced scientists, cutting-edge analytical technologies, and client-focused approach ensure that we provide the highest quality solutions for your drug development needs. Partner
with us for robust, reliable, and regulatory-compliant analytical methods.
Contact ARSI Canada Inc. today to learn more about our method development services and how we can support your drug development projects with precision and expertise.
Call us today for a free customized quote.
