ANALYTICAL METHOD DEVELOPMENT

• Assay (Quantification)
• Potency assessment
• Dissolution (dissolution rate) studies
• Impurity (related compounds) analysis
• Moisture analysis
• Heavy Metal analysis
• Physical and chemical tests
• Other customer-oriented tests
• Drug stability tests

Novagenix determines, develops and validates the analytical methods required for the physical and chemical analysis of its formulations. This current pharmacopoeia for analytical work (Turkey Pharmacopoeia, European Pharmacopoeia, United States Pharmacopoeia and British Pharmacopoeia) and Turkey Ministry of Health, Pharmaceutical Development ICH Q8 (R2) takes into account the regulations and guides. Laboratory quality management system complies with ISO 9001 and 17025 standards.