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Alpex Pharma

High-Quality Formulation Development and Manufacturing

More info about Alpex Pharma

Stability Management Services

Alpex Pharma

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
  • Odoralpex
  • pH
  • Packaging integrity

Complete Microbiological Capabilities
Bioburden Micro- limits LAL Preservative Effectiveness

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