PHARMACEUTICAL

Control of pharmaceutical products

• Assay
• Impurities
• Related substances
• Residual solvents
• Dissolution rate
• Identification
• Viscosity
• Heavy metals
• Humidity
• Microbiological control
• Endotoxins
• Assay by microbiological method: antibiotic assessment, determination of B12 vitamin
• Any other specified by the product

Water control

• Purified water assays according to Pharmacopeia specifications
• Potability

Surface and environmental control in production rooms

Isolation, purification and identification of products and impurities

DMF development

• Analytical and experimental support
• Structure and drafting support

Control of products in development

• Preservative challenge testing
• Ames test

Analytical methods

• Design and set up of methods for physicochemical and microbiological analysis
• Method validation according to ICH

Stability studies of pharmaceutical products

• Protocol drafting for stability studies
• Sample storage in climatic chambers according to ICH conditions
• Analytical control
• Report drafting of the stability study