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.

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:

Method Development and Validation

We specialize in creating and validating reliable analytical methods that comply with regulatory standards.

Method Development

ARSI Canada Customized Chromatographic Method development
ARSI Canada Spectroscopic Method development
ARSI Canada Formulation related method development

Method Validation

ARSI Canada Accuracy and precision testing
ARSI Canada Specificity and sensitivity validation
ARSI Canada Linearity and range determination
ARSI Canada Robustness and reproducibility studies

Learn More

Impurity Profiling

We provide comprehensive impurity profiling to identify and quantify impurities, ensuring the safety and efficacy of your drug substances and products.

Impurity Identification

ARSI Canada Structural elucidation using advanced spectroscopy

Impurity Quantification

ARSI Canada Method development for accurate quantification
ARSI Canada Threshold determination and control

Degradation Product Analysis

ARSI Canada Stress testing for degradation pathways
ARSI Canada Development of stability-indicating methods

Learn More

Method Transfer and Optimization

Ensure seamless transfer and optimization of your analytical methods with our expert services.

Method Development

ARSI Canada Comparative studies between laboratories
ARSI Canada Protocol and documentation alignment

Method Optimization

ARSI Canada Efficiency improvements
ARSI Canada Sensitivity enhancements
ARSI Canada Cost reduction strategies

Learn More

Physical and Chemical Characterization

Our detailed physical and chemical characterization services provide essential insights into the properties of your drug substances and products.

Chemical Characterization

ARSI Canada Chromatography (HPLC, GC)
ARSI Canada Spectroscopy (NMR, FTIR, UV-Vis)

Physical Characterization

ARSI Canada Particle size analysis
ARSI Canada Thermal analysis (DSC, TGA)
ARSI Canada Polymorphism studies

Forced Degradation Studies

Understand degradation pathways and develop stability-indicating methods with our forced degradation studies.

Stress Testing

ARSI Canada Exposure to light, heat, pH, and oxidation
ARSI Canada Identification of degradation products

Stability-Indicating Method Development

ARSI Canada Creation of methods to monitor degradation
ARSI Canada Validation of stability-indicating methods

Learn More

Quality Control (QC) Testing

Ensure your products meet quality standards with our comprehensive QC testing services.

Raw Material Testing

ARSI Canada Identity and purity testing
ARSI Canada Potency determination

Intermediate and Final Product Testing

ARSI Canada Contaminant analysis
ARSI Canada Potency and purity testing
ARSI Canada Batch release testing

Learn More

Bioanalytical Testing

Bioanalytical Method Development and Validation

ARSI Canada LC-MS/MS method development
ARSI Canada ELISA assay development
ARSI Canada Regulatory guideline validation

[Placeholder for Bioanalytical Testing Image]

Learn More

Regulatory Support

Our regulatory support services ensure your analytical methods and data are compliant with all necessary regulations.

Documentation Preparation

ARSI Canada Regulatory submission documents
ARSI Canada Method validation reports

Regulatory Compliance

ARSI Canada Response to regulatory queries
ARSI Canada Audit readiness and support

Learn More

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 Fischer
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

ARSI Canada Expertise in complex method development, validation and Tech Transfer of organic, inorganic, residual solvents, trace metals
ARSI Canada Genotoxins Method Development and Screening
ARSI Canada Stability indicating methods and forced degradation studies

Screening

ARSI Canada Organic impurities: Characterization and screening using HPLC/UPLC, LC-MS/MS, GC-MS etc.
ARSI Canada Nitrosamine: Risk Evaluation and Screening
ARSI Canada Class 1, Class 2A and Class 2B: Elemental screening by ICP-MS

Cleaning Validation, Rinse and Coupon Recovery Studies

ARSI Canada 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.