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Development services
Analytical services
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 |