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