Analytical Development

Our R&D team develop analytical methods for identification and quantitation of raw materials in finished products or bulk. We then validate the technique on customer request and we work in accordance with GMP and ICH.

We intervene at various steps:

• Analytical method for determination of active ingredients and excipients
• Analytical method for identification and quantitation of impurities
• Analytical method for detection of related compounds
• Analytical method for dissolution in vitro assays (DIV)

Further investigation is sometimes necessary to ensure the contact between the product and its container (flask, tubes, etc.) does not deteriorate the composition of the product. Stress degradation studies control the evolution of the product in a situation of stress (light, humidity, etc.)

• Stress degradation assays
• Content-container interaction studies
• Analysis of packaging materials (PP, PE or PET)