Analytical Services

Analytical services provided by ARSI Canada include the testing and analyzing pharmaceuticals, medical devices, and other products.

In our state-of-the-art analytical laboratory, we can support your analytical development and validation needs.
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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.

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Analytical services also involve assessing the pharmaceutical properties of the drug, such as solubility, stability, absorption, and bioavailability.

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What we do

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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.

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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

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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

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Cleaning Validation, Rinse and Coupon Recovery Studies

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Our Instrumentations

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We have well equipped Analytical facility with access to the following state-of-the-art equipment:

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  • HPLC
  • GC-MS / FID
  • ICP-AES, MS, OES
  • LC-MS/MS
  • FTIR / FTIR Microscope
  • 1H NMR
  • 13-C NMR
  • 19F NMR
  • 2D NMR, COSY, NOESY, HMBC
  • FTIR w/ATR
  • XRD
  • Fluorescence
  • CD
  • MALDI-TOF
  • FAB
  • TOC/TN Analysis
  • Karl fisher

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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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Why ARSI for Analytical Services:

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ARSI Canada has a strong team of experienced Analytical Chemists who can develop simple and complex methods for Active Pharmaceutical Ingredients (APIs), raw materials, and finished doses. We can use DoE and or the traditional one-step-at-a-time approach to develop reliable, robust, fit-for-purpose analytical methods or to improve existing methods that can reduce overall product analysis time and be more cost-effective. Our receptive and collaborative approach is especially beneficial when working with rare, highly expensive impurities.

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We can help you through:

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  • Method development of organic impurities, assay, residual solvents, elemental impurities, water content, genotoxins, nitrosamines etc.
  • Complete validation of your methods following ICH guidelines
  • Verification of compendial methods
  • Equivalency study of your house method with the compendial methods
  • Reviewing your method validation and transfer data from other third-party vendors
  • Performing forced degradation studies of your methods to confirm their suitability for shelf life and stability studies
  • Developing and validating cleaning methods for residue in solutions and on different surfaces.

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