Analytical services

We offer the following analytical services:

  1. Isolation and characterization of impurities and degradation products
  2. Analytical method development and validation.
  3. Analytical testing services.

Isolation and characterization of impurities and degradation products

Impurities arise during API synthesis must be identified, according to the ICH Q3A(R2) guideline, . Additionally, any degradation product observed during stability studies at a level greater than the identification threshold should also be identified according to ICH Q3B(R2) guideline.

Resonance Research Lab has extensive experience and accessibility to a wide range of analytical and synthetic equipment to perform impurity identification for pharmaceutical products.

Our experienced scientists perform detailed isolation and characterization using a diverse range of technologies including:

  • Development of mass spectrometry (MS)-suitable high performance liquid chromatography (HPLC) method for the separation of the examined impurity
  • High resolution mass spectrometry (HRMS) analysis for the determination of molecular weight and formula of the impurity using a QTof mass spectrometer
  • Isolation of the impurity, from the drug product, using preparative high performance liquid chromatography (HPLC)
  • Nuclear magnetic resonance (NMR) analysis for the structure elucidation of the impurity
  • Proposition of the molecular structure of the examined impurity on the basis of the MS and NMR analyses results
  • Chemical synthesis of the reference material with the proposed structure
  • Confirmation of the proposed structure by comparative HPLC-MS/MS analysis employing the synthesised reference material
  • Suggestion of the impurity origin and its formation pathway

Analytical method development and validation

Method development and validation is an essential step to determine that analytes of interest can be reliably detected and quantified for routine sample analysis. Our team has a long experience in method development, therefore they can swiftly develop the most appropriate method for your product.

Method development and validation of the following can be provided:

  • Stability indicating method of analysis for testing related substance and degradation product  in drug substance and drug product.
  • Assay method of analysis of active ingredient in drug product 
  • Dissolution method of analysis

Analytical testing services

  The following testing services can be provided:

  • HPLC analysis
  • GC-FID analysis
  • Karl Fischer titrators for water determination