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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
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 |