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In our state-of-the-art analytical laboratory, we can support your analytical development and validation needs.
What is Analytical Service
Analytical services in the drug development process involve using laboratory techniques to evaluate the safety, efficacy, and quality of drug candidates. This includes techniques such as chromatography, spectroscopy, and other analytical methods to measure impurity levels in various drug samples.
Analytical services also involve assessing the pharmaceutical properties of the drug, such as solubility, stability, absorption, and bioavailability.
Our Services
At ARSI Canada Inc., we deliver top-notch analytical development services tailored to meet the needs of the pharmaceutical and biotechnology sectors. Our cutting-edge facilities and expert team ensure precision, compliance, and efficiency in your drug discovery and development processes. Explore our key service areas and their sub-services below:
We specialize in creating and validating reliable analytical methods that comply with regulatory standards.
Method Development
- Customized Chromatographic Method development
- Spectroscopic Method development
- Formulation related method development
Method Validation
- Accuracy and precision testing
- Specificity and sensitivity validation
- Linearity and range determination
- Robustness and reproducibility studies
We provide comprehensive impurity profiling to identify and quantify impurities, ensuring thesafety and efficacy of your drug substances and products.
Impurity Identification
- Structural elucidation using advanced spectroscopy
Impurity Quantification
- Method development for accurate quantification
- Threshold determination and control
Degradation Product Analysis
- Stress testing for degradation pathways
- Development of stability-indicating methods
Ensure seamless transfer and optimization of your analytical methods with our expert services.
Method Development
- Comparative studies between laboratories
- Protocol and documentation alignment
Method Optimization
- Efficiency improvements
- Sensitivity enhancements
- Cost reduction strategies
Our detailed physical and chemical characterization services provide essential insights into the properties of your drug substances and products.
Chemical Characterization
- Chromatography (HPLC, GC)
- Spectroscopy (NMR, FTIR, UV-Vis)
Physical Characterization
- Particle size analysis
- Thermal analysis (DSC, TGA)
- Polymorphism studies
Understand degradation pathways and develop stability-indicating methods with our forced degradation studies.
Stress Testing
- Exposure to light, heat, pH, and oxidation
- Identification of degradation products
Stability-Indicating Method Development
- Creation of methods to monitor degradation
- Validation of stability-indicating methods
Ensure your products meet quality standards with our comprehensive QC testing services.
Raw Material Testing
- Identity and purity testing
- Potency determination
Intermediate and Final Product Testing
- Contaminant analysis
- Potency and purity testing
- Batch release testing
Bioanalytical Method Development and Validation
- LC-MS/MS method development
- ELISA assay development
- Regulatory guideline validation
Our regulatory support services ensure your analytical methods and data are compliant with all necessary regulations.
Documentation Preparation
- Regulatory submission documents
- Method validation reports
Regulatory Compliance
- Response to regulatory queries
- Audit readiness and support
Why Choose ARSI Canada Inc.?
At ARSI Canada Inc., we are committed to excellence in analytical development. Our experienced team, advanced technology, and client-focused approach guarantee high-quality, timely, and cost-effective solutions tailored to your drug development needs.
Partner with us to navigate the complexities of drug discovery and development confidently.
Our Instrumentations
We have well equipped Analytical facility with access to the following state-of-the-art equipment:
- 19F NMR
- 2D NMR, COSY, NOESY, HMBC
- FTIR w/ATR
- XRD
- Fluorescence
- CD
- MALDI-TOF
- FAB
- TOC/TN Analysis
- Karl fisher
- HPLC
- GC-MS / FID
- ICP-AES, MS, OES
- LC-MS/MS
- FTIR / FTIR Microscope
- 1H NMR
- 13-C NMR
What we do
Analytical services provided by ARSI Canada include the testing and analyzing pharmaceuticals, medical devices, and other products. This can involve various techniques, such as chemical and physical analysis, chromatography (HPLC, LC-MS, GC, GC-MS, IC), spectroscopy and ICP-MS. These services help to ensure the quality and safety of a product by detecting any contaminants, impurities, or other issues.
Method Development and Validation:
- Expertise in complex method development, validation and Tech Transfer of organic,
- inorganic, residual solvents, trace metals
- Genotoxins Method Development and Screening
- Stability indicating methods and forced degradation studies
Screening:
- Organic impurities: Characterization and screening using HPLC/UPLC, LC-MS/MS, GC-MS etc.
- Nitrosamine: Risk Evaluation and Screening
- Class 1, Class 2A and Class 2B: Elemental screening by ICP-MS
Cleaning Validation, Rinse and Coupon Recovery Studies
Our experts can develop methods from trace residue levels like 0.5 µg/mL to 25 µg/mL for rinse solutions and 5 µg/in 2 to several hundred µg/in 2 for swab samples. We can help you determine rinse, swabs, and coupon recoveries for your cleaning methods.
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