Analytical services

Methods development and validation for quality control and stability testing

API characterization: solubility, polymorphysm, particles sizes distribution

Stress testing

Discriminating dissolution tests development

Advanced equipment

Container / closure systems compatibility studies (leachables, sorption studies) Functional testing

Unknown substances identification, synthesis and characterization

Quality control

Inter-lab analytical method transfer according to ICH or customized protocols

Stability studies following ICH and WHO recommendations
(10 rooms for different storage conditions, from 2–40+ cubic meters capacity per chamber)

Active ingredients and finished products monograph preparation

ICH Stability Programs

Qualified ICH climatic chambers equipped with recording systems and security alarms provide:

  • Climatic zones I, II, III, IV
  • Reduced humidity for semi-permeable products
  • Sun-test for photo-stability testing.

Crystal software provides sample handling with 100% traceability of entry and removal of stock. Storage of products is provided as a stand-alone service, and may or may not include the analysis package. Climate controlled and regular shipping services are available.

ICH Climatic Storage Capacity

ICH climatic chambers

Please move the table from left to right
Conditions Volume in m3
25°C/60% RH 41
25°C/40% RH 23
30°C/65% RH 27
30°C/70% RH 6
30°C/75% RH 16
30°C/35% RH 5
40°C/75% RH 27
40°C/25% RH 3
5°C 2
-20°C 0.5

Analytical development

Production of commercial batches

Regulatory expertise