Stability Management Services

State of the art Facilities

• More than 40 sq.m of storage capacity
• Dedicated area for stability studies
• Monitoring of incubation conditions 24h/day, 7 days a week
• Remote alarm system

A full range of storage conditions according to ICH requirements

• -20°C
• 5°C
• 25°C; 60% RH
• 30°C; 65% RH
• 30°C; 75% RH
• 40°C ;75% RH
• Photo stability testing
• Thermal shock
• Special conditions

Full materials capability

• Active drugs Substances.
• Excipients
• Solids
• Semi-solids
• Liquids
• Ointments
• Suppositories
• Parenteral
• Lyophilized products
• Transdermal
• Aerosols

Complete Analytical Capabilities

• Development and validation of the stability indicating methods
• Assay
• Impurities
• Degradents
• Particle size
• Dissolution
• Disintegration
• Hardness
• Color
• Thickness
• Diameter
• Moisture
• Friability
• Viscosity
• Osmolality
• Appearance
• Odor
• pH
• Packaging integrity

Complete Microbiological Capabilities
Bioburden Micro- limits LAL Preservative Effectiveness