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

ARSI Canada

HPLC Method Development

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 and degradation products to ensure product safety and efficacy.
• Dissolution Testing: Custom HPLC methods for evaluating the release profiles of solid oral dosage forms.

ARSI Canada

GC Method Development

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

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NMR Spectroscopy

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.

ARSI Canada

UV-Vis Spectroscopy

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.

ARSI Canada

LC-MS/MS Method Development

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.

ARSI Canada

GC-MS Method Development

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

ARSI Canada

Particle Size Distribution

• 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.

ARSI Canada

Polymorph Characterization

• X-ray Powder Diffraction (XRPD): Identifying and quantifying polymorphic forms of APIs.
• Differential Scanning Calorimetry (DSC): Analyzing thermal properties of different polymorphs and excipients.