Custom peptide synthesis involves designing and creating specific peptide sequences that don't occur naturally. These peptides find wide-ranging applications in areas like vaccine development, drug discovery, diagnostics, antibody research, and studying protein interactions.

Custom organic synthesis enables researchers to obtain novel organic molecules with tailored properties and structures. This is essential for exploring new pharmaceuticals, developing functional materials, and advancing our understanding of biological processes.

Proximity to a thriving life sciences and research hub Potential for local collaboration and access to specialized resources Convenient geographical location within North America

Custom peptide synthesis offers a wide range of modifications, including: Amino acid substitutions (using natural or non-natural amino acids) Backbone alterations (e.g., N-methylation, cyclization) Addition of labels or tags (fluorescent dyes, biotin, etc.) PEGylation to improve solubility and stability

Yes, our expertise extends to the synthesis of complex organic molecules with diverse functional groups. Our chemists possess in-depth knowledge of reaction mechanisms and synthetic strategies, enabling them to construct challenging molecules.

We implement a rigorous quality control process involving advanced analytical techniques, including: High-performance liquid chromatography (HPLC) to assess purity Nuclear magnetic resonance (NMR) spectroscopy to confirm structure Mass spectrometry (MS) for molecular weight determination

Turnaround time depends on project complexity and scale. Simpler projects may be completed within weeks, while more complex syntheses could take several months. We'll provide an estimated timeline after assessing your requirements.

Cost is primarily influenced by: Complexity of the target molecule Number of synthetic steps required Scale of the project (larger quantities typically have lower per-unit costs) Cost of starting materials and any specialized reagents

Method development in pharmaceuticals involves creating and optimizing analytical methods to accurately measure the properties and concentration of drug substances and products. This process ensures the reliability, precision, and accuracy of analytical results, crucial for quality control, regulatory compliance, and successful drug development.

Method development is essential in drug development because it ensures that analytical methods are reliable and capable of accurately measuring the active ingredients, impurities, anddegradation products. This is vital for ensuring the safety, efficacy, and quality of pharmaceutical products, and for meeting regulatory requirements.

ARSI Canada Inc. offers a wide range of method development services, including HPLC method development, GC method development, NMR spectroscopy, UV-Vis spectroscopy, LC-MS/MS method development, and GC-MS method development. Our services are tailored to meet the specific needs of each clients project.

ARSI ensures the reliability of developed methods through rigorous validation processes. We follow International Council for Harmonisation (ICH) guidelines to validate methods for accuracy, precision, specificity, sensitivity, linearity, range, robustness, and reproducibility. This ensures that our methods are reliable and compliant with regulatory standards.

Yes, ARSI has extensive experience in developing methods for complex formulations. This includes particle size distribution, polymorph characterization, dissolution testing, stability studies, and rheological properties. We use advanced analytical techniques to address the unique challenges of complex formulations.

The process for developing a new analytical method at ARSI involves several key steps: understanding the clients needs, selecting appropriate analytical techniques, optimizing method parameters, conducting preliminary tests, validating the method according to regulatory guidelines, and providing comprehensive documentation and support.

The duration of method development varies depending on the complexity of the project and specific requirements. Typically, method development can take anywhere from a few weeks to several months. ARSI works closely with clients to provide accurate timelines and ensure timely delivery of results.

ARSI's method development services benefit a wide range of industries, including pharmaceuticals, biotechnology, environmental testing, food and beverage, cosmetics, and forensics. Our expertise and advanced analytical capabilities make us a trusted partner for various sectors requiring precise and reliable analytical methods.

ARSI ensures regulatory compliance in method development by adhering to guidelines set by the International Council for Harmonisation (ICH), the United States Pharmacopeia (USP), and other relevant regulatory bodies. Our methods are developed and validated to meet the stringent requirements of regulatory agencies worldwide.

Yes, ARSI specializes in developing stability-indicating methods. These methods are designed to detect and quantify degradation products and impurities under various stress conditions, ensuring the stability and shelf-life of drug products. Our stability-indicating methods are crucial for regulatory submissions and quality assurance.

Choosing ARSI for method development offers several key benefits: access to experienced scientists, advanced analytical technologies, customized solutions, comprehensive validation, regulatory compliance, and a client-focused approach. ARSI is dedicated to delivering high-quality, reliable, and timely analytical services.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

Forced degradation studies involve subjecting drug substances and products to stress conditions to accelerate degradation processes and identify potential degradation products. These studies assess the stability and degradation pathways of pharmaceuticals under various stress conditions.

Forced degradation studies are important in pharmaceutical development for stability assessment, degradation pathway identification, regulatory compliance, and risk assessment. They provide critical data on the stability and degradation behavior of drug substances and products, supporting formulation development and regulatory submissions.

Forced degradation studies include stress conditions such as temperature, light, pH, and oxidation. These stress conditions accelerate degradation reactions and help assess the stability and susceptibility of drug substances and products to degradation.

ARSI conducts forced degradation studies using advanced instrumentation and techniques. We subject samples to stress conditions, analyze degradation products using chromatography and mass spectrometry, and provide comprehensive reports summarizing study findings and recommendations.

Forced degradation studies have regulatory significance as they support regulatory submissions by demonstrating product stability, identifying degradation pathways, and justifying proposed storage conditions and shelf-life specifications. They ensure compliance with regulatory guidelines (e.g., ICH Q1A) and support the safety and efficacy of pharmaceutical products.

The duration of a forced degradation study depends on factors such as sample complexity, the number of stress conditions tested, and specific project requirements. Typically, forced degradation studies can take several weeks to a few months to complete.

Yes, ARSI can identify and characterize degradation products using advanced analytical techniques such as chromatography, mass spectrometry, and spectroscopy. We provide detailed structural information and confirmation of degradation product identities to support formulation optimization and stability testing.

ARSI provides recommendations for formulation optimization, stability testing, and risk mitigation based on the findings of forced degradation studies. These recommendations aim to ensure the stability and safety of drug substances and products throughout their lifecycle.

Forced degradation studies support formulation development by providing critical data on the stability and degradation behavior of drug substances and products. This information guides the selection of excipients, formulation strategies, and packaging materials to ensure product stability and efficacy.

Forced degradation studies benefit industries such as pharmaceuticals, biotechnology, nutraceuticals, and cosmetics. These studies are essential for assessing the stability and safety of drug substances and products and ensuring regulatory compliance across various sectors.

Yes, ARSI can conduct forced degradation studies for complex formulations, including drug-device combinations, liposomal formulations, and nanoparticle-based formulations. Our expertise and advanced instrumentation allow us to assess the stability and degradation behavior of diverse pharmaceutical products.

You can contact ARSI Canada Inc. for forced degradation study 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 and regulatory submission requirements.