PROJECTS

Troubleshooting: Distillery, Water Treatment, Process Laboratory

Client: an important chemical-pharmaceutical multinational engaged in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices.

Sector: chemical-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.

The Client needed to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments. For this activity, the Client relied the skills of the S4BT Lab Consultants, who took care of both the analytical part of the project (development of the method and execution of all analytical tests), and of the documentary part, including the writing of the protocols and the related report.

Our contribution

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

The following requirements were verified for the development:

Specificity
A method’s ability to distinguish between the analyte to be measured and other substances
Linearity
The ability to provide results directly in proportion to the concentration of analytes in the samples within a certain validity range
Accuracy
Analysis of samples with a known concentration that must fall within a certain validity range
Quantification limit
The minimum point at which a compound can be quantified
Determination limit
The minimum point at which a compound can be seen but not quantised.
Robustness
The sensitivity of an analytical method to variations in experimental conditions
Repeatability
The determination of repeatability and instrumental precision

Result

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

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Projects completed in 2019

CLIENT

Pharmaceutical Company

An international pharmaceutical contract manufacturer specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

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