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PROJECTS

Analytical method validation for the EHS department

Client: a company that has always been involved in the research, development and marketing of innovative drugs.

Sector: Pharmaceutical

Objective: to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments.

Project

The client company is a leading international chemical-pharmaceutical producer, engaged for decades in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices.

In view of continual improvement and compliance with sector regulations and internal procedures, the Client saw the need to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments.

Our contribution

The S4BT Consultants took care of both the analytical part, (including the development of the method and the execution of all the analytical tests), and the documentary part, including the writing of the protocols and the related report.

The following requirementswere verified for the development:

  • specificity
  • the capacity of a method to distinguish the analyte it is intended to measure from others
    substances
  • linearity
  • the capacity to provide results that are directly proportional to the concentration of
    analytes in samples within a certain validity range
  • accuracy
  • analysis of samples with a known concentration that must fall within a certain validity range
  • quantitation limit
  • the lowest point at which it is possible to quantify a compound
  • determination limit
  • the minimum point at which a compound can be seen but not quantified
  • resilience
  • the sensitivity of an analytical method to variations in experimental conditions
  • replicability
  • determination of repeatability and instrumental precision

Result

The analytical method developed and validated has fully satisfied all the parameters established by the client and those required by the reference standards. The method is still used successfully by the pharmaceutical company.

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