Products and Services

RSS

Overview of Services

• Analytical method development performed within the guidelines of regulatory agencies
• Rapid results on the chemical and physical properties of the raw materials and finished products
• Analytical results are compiled and delivered quickly, precisely, reliably and treated according to the applicable regulatory requirements

General Analytical Services

• Pre-formulation analysis Development, optimization, and validation of the analytical methods for active ingredients, excipients, and finished products:
  • Assay
  • Impurities (Related Substances)
  • Content and Blend Uniformity
  • Dissolution (UV, HPLC)
  • Degradation products (including forced degradation)
  • Analytical methods to verify the cleaning validation
• Stability studies according to the ICH guidelines
  • 25±2°C / 60±5% RH
  • 30±2°C / 65±5% RH
  • 40±2°C / 75±5% RH
• Transfer of the analytical methods to a third party laboratory
  • Where: Laboratory location as chosen by the Client
  • When: Transfer at the time chosen by the Client, either for the manufacturing of either clinical or commercial lots
• Compatibility studies between active ingredients, excipients, and packagings
• Analysis of controlled substances

Specific Analytical Services

• Identification and quantitation of impurities and degradation products
• Photo stability studies
• Microbiological testing
• Analysis of the polymorphic form(s) of the active ingredients
• Determination and particle size and distribution
• Permeability studies (PAMPA or Caco-2)
• Solubility determination
• Water content determination

Evaluation of Active Ingredients

• Selecting suppliers, evaluation of prices, availability, and delivery dates
• Evaluation of manufacturing processes and conditions, and quality of active ingredients
• Definition and justification of specifications of the active ingredients