Pharmaceutical

Pharmaceutical Testing

Pharmaceutical testing is a specialized laboratory process designed to assess the quality, potency, and safety of pharmaceutical products. Its primary goal is to verify efficacy, proper dosage, and compliance with regulatory standards—ensuring the health and safety of end users.

The production and consumption of pharmaceutical products are strictly regulated. Cotecna helps you ensure compliance with relevant safety and quality requirements. Our testing services reduce risks associated with contamination, product recalls, and regulatory penalties, while strengthening consumer confidence and supporting your brand reputation.

Scope of Pharmaceutical Products and Services

• Cotecna’s capabilities cover a wide range of product categories, including:
• Raw materials and excipients
• Active Pharmaceutical Ingredients (APIs)
• Bulk drugs and finished products
• Herbal products
• Medical devices
• Primary packaging materials
• Our laboratories are equipped to perform testing for:
• Contaminants and nitrosamines
• Pesticides and elemental impurities
• Pyrrolizidine alkaloids
• Pharmacopoeia methods
• Assay and impurity profiling
• Stress test studies
• Residual solvents
• Stability studies

Service Portfolio

• Cotecna’s pharmaceutical testing services include:
• Analytical Activities (Chemical and Physical Tests)
• Stability Studies (ICH Q1 guidelines)
• Method Validation (ICH Q2 (R1) guidelines)
• Protocol development and study
• Analytical support for process validation
• Guidance on primary packaging material selection
• Cleaning validation
• Root cause investigation and support
• Full-service stability studies (Zones I, II, IV)
• Annual product reviews
• API supplier audits
• Impurity identification
• API titration to specification limits
• Stress test studies
• Residual solvent testing (USP standards)
• ICH Q3D studies for metals
• Nitrosamine investigation