HPLCs
equipo test de dissolución

Our Analytical Development and Quality Control laboratory develops and validates various analytical methods for the analysis and control of medicines for human and veterinary use, as well as for food, dietary supplements, cosmetics, and medical devices. It also provides the necessary analytical support during the development of a drug. All equipment meets the requirements of Good Laboratory Practices (GLP), and the staff is qualified and trained in the various techniques available and used in all analytical processes.
The management and execution of analyses are carried out in accordance with current regulations (ISO, GMPs, ICH, etc.) and in compliance with the established Standard Operating Procedures (SOPs) for their application.

Active Pharmaceutical Ingredient (API) Characterization Studies
  • Solubility at different pH levels, following USP / ICH M9 recommendations
  • Particle size determination, both in dry and dispersed states, using a Mastersizer
  • Impurity Profile Characterization
  • Raw Material Standardization
  • Forced Degradation ('Stress Testing') of Active Pharmaceutical Ingredients
  • Development and Validation of Analytical Methods for the Active Pharmaceutical Ingredient: Assay and Degradation Products
Development and Validation of Analytical Methods for Finished Products
  • Assay of Active Pharmaceutical Ingredient or Preservatives in Finished Products using HPLC
  • Assay of Active Pharmaceutical Ingredient in Content Uniformity using HPLC
  • Determination and Quantification of Degradation Products
  • Dissolution Testing using both UV-Vis Spectrophotometry and HPLC
  • Determination of Water Content
  • Enantiomeric Purity
  • Determination of Traces on Surfaces or in Rinse Waters in Cleaning Validation
  • Analytical Method Transfer
Analytical Support during Galenic Development
  • Search for Discriminatory Dissolution Media for Galenic Formulation Studies of Solid Dosage Forms
  • Dissolution Profile and Pre-chemical Stability Analysis as Formulation Support
  • Excipients Compatibility
  • Comprehensive Characterization of Reference Products to Support Galenic Development
  • Comparative Dissolution Profile Studies Against Reference Products at Different pH Levels According to ICH Guidelines
Quality Control of Finished Products
  • Performing Physicochemical and Galenic Analysis of Finished Products to Meet Finished Product Specifications
  • Identification Test by HPLC with DAD Detector
  • Appearance (color, clarity)
  • Active Ingredient Content (Assay): UV-Vis, HPLC
  • Quantification of Degradation Products by HPLC
  • Physical Determinations: pH, Viscosity, Density, etc.
  • Water Content (Karl Fischer)
  • Moisture (Loss on Drying)
  • Pharmaceutical Form Determinations: Breakage Resistance, Friability, Disintegration, Dissolution Tests, etc.
  • Determination of Individual Parameters Included in Finished Product Specifications
Stability Studies
  • According to ICH: Drafting of Protocols and Reports for Their Implementation. External Climatic Chambers
  • Photostability
  • In-Use Stability for Determining Usage Periods in Multidose or Reconstitution Products
  • Ongoing Stability
  • Stability in Drinking Water for Veterinary Medicinal Products