Analytical Development & Chemistry

Santé Laboratories offers an extensive scope of formulation characterization and analytical services to support the development, testing, and manufacturing process as efficiently as possible. With relevant experience in cannabinoid sciences, Santé Laboratories will develop phase appropriate methods to your specific needs to provide a thorough understanding and characterization of cannabinoid formulations regardless of stage in development and commercialization.

Experienced Analytical and Drug Development Team

  • Fast and flexible access to cutting-edge analytical technologies and expertise with various instrumentation with ultra-low sensitivity and specificity including GC-MS/MS and LC-MS/MS
  • Experience and passion to develop high precision, sensitive, and robust methods to withstand various life cycles of product development
  • Access to relevant and unrivaled expertise in cannabinoid chemistries and analytical sciences to support the product development process
  • Experience developing and validating stability-indicating assays for a diverse number of cannabinoids in various formulation formats
  • Experience in logistics including sample transportation in addition to short-term and long-term ICH stability studies
  • Experience transferring, developing and validating bioanalytical methods for quantitative analysis to support nonclinical studies
  • In-house microbiology for QC of raw materials, active ingredients, and finished products

State-of-the-Art Instrumentation
The analytical group at Santé Laboratories is fully equipped with state-of-the-art instrumentation and trained scientists to confidently offer a full range of chemistries and analytical support to characterize cannabinoid formulation as well as develop stability-indicating test methods to release and validate shelf-life through its intended use.

When preparing for GMP manufacturing and stability testing, Santé Laboratories can provide the following analytical services:

  • Develop and phase appropriately validated stability-indicating methods leveraging an array of detection methods such as UV, CAD, FLD, MS, and MS/MS
  • Perform in-process and lot release testing
  • Excipient screening and compatibility testing
  • Lipid and surfactant analysis and characterization using CAD and FLD
  • Draft, execute, develop, and validate methods according to ICH guidelines.
  • Identification of cannabinoid and formulation degradants during forced degradation, photostability, and freeze thaw studies
  • Fragmentation analysis of degradants and impurities
  • Exploratory E&L (extractables and leachables) testing to identify additives and impurities using a variety of analytical techniques to justify packaging compatibility and integrity
  • Isolation of degradants and impurities using preparatory chromatography for NMR analysis to support structure elucidations
  • Store and manage stability programs and samples.
  • Author protocols, interim and final reports to meet most regulatory requirements
  • Troubleshoot and facilitate successful tech transfer of existing methods to other CROs/CDMOs


Speed, flexibility, and expertise to triage and address analytical and development challenges to avoid time-consuming and costly rework

With speed and flexibility at the center of everything we do, we believe successful and appropriate analytical method development enables a smooth and rapid pathway from development to clinic, so we will work closely to ensure these goals are met. In addition, Santé Laboratories also offers a comprehensive range of routine analytical testing services with relevant understanding of cannabinoids sciences at the center following documented and established methodologies:

  • Raw material, IPT, and product release testing
  • Laser diffraction particle size characterization
  • Routine cannabinoid and alkaloid assay
  • Moisture analysis by karl fischer
  • Water activity
  • Loss on drying
  • Residue on ignition (ash content)
  • Preservative assay
  • Thermo analysis by Differential Scanning Calorimetry (DSC)
  • Purity by HPLC, UHPLC and LC-MS/MS
  • Potency testing following methods based on USP <621> and
  • Chromatography methodologies such as LC-DAD, LC-MS, LC-MS/MS, GC-MS, GC-MS/MS
  • Spectroscopy e.g., UV-VIS, FTIR, ICP
  • Solution viscosity
  • pH by USP <791>
  • Osmolality
  • Residual solvent testing per USP <467>
  • Heavy metals per USP <232> USP <233> and USP <2232>
  • Microbial enumeration testing by USP <61> and USP <2021>
  • Objectionable organism testing by USP <62> and USP <2022>
  • Pesticides and mycotoxins per USP <561>
  • Antimicrobial Effectiveness (AME) Testing per USP <51> and method suitability
  • Method suitability testing for USP <51> and USP <61> and <62>
  • Various compendial testing
  • Various AOAC and State-mandated analytical methods