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Analytical

Corealis supports both formulation development and clinical supply manufacturing with comprehensive analytical services.

The Corealis analytical team develops suitable analytical methods to ensure success.

These steps include the development and qualification of analytical methods, GMP release testing and stability analysis. The analytical services team supports internal formulation development, alongside clinical supply manufacturing projects providing accurate analysis of raw materials or finished products.

A commitment to quality assurance at every step of the process; to help ensure this, regular quality reviews for each stage of the process are key.

The team can support clinical studies in countries across the globe, providing:

  • Qualification and validation of analytical methods
  • GMP analysis for release testing
  • Stability studies

These measures ensure compliance with local regulatory guidelines.

Learn more about Corealis’ analytical services

Contact the team today.

Pre-formulation and formulation development

The Corealis team consists of analytical specialists overseeing all stages of the pre-formulation and formulation,with expertise in analytical method development and sample analysis using stringent QA and adherence to GLP-based SOPs.

The team conducts thorough method development for the evaluation of API-excipient and API-API compatibility, along with analysis of drug product prototype formulations and intermediates, and drug finished products.

The analysis includes, but is not limited to:

  • Assay
  • Impurities (related substances)
  • Content and blend uniformity
  • Dissolution (type I and II)
  • Degradation products (including forced degradation)
  • Solubility studies
  • Stability studies
  • Compatibility studies (API-API, API-Excipients)
  • Cleaning verification

The team executes stability studies according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

Specific analytical services include:

  • Identification and quantification of impurities and degradation products
  • Photostability studies
  • Microbiological testing
  • Analysis of the polymorphic form(s) of the active ingredients
  • Determination and particle size and distribution
  • Permeability studies (PAMPA)
  • Solubility determination
  • Water content determination

Measurements of the physical and chemical properties of an API allow formulators to:

  • Select suitable API and API moieties, suitable for oral solid dosage formulation
  • Define formulation development strategies
  • Identify API variability between different batches

Contact Corealis

Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.