Chemical analysis under Good Manufacturing Practices (GMP) Standards
MANY YEARS OF EXPERIENCE IN THE FIELD OF PHYSICO-CHEMICAL ANALYSIS IS OUR GUARANTEE
In response to bio-health sector needs, IQS offers the possibility to perform different physicochemical tests under GMP regulatory framework. Since September 2017, IQS has been certified as GMP pharmaceutical laboratory to carry out Quality Control activities (physicochemical analysis) of active ingredients, medicines and raw materials in general; related to both marketed medicines and medicines under investigation.
IQS has a total of 6 laboratories: chromatography, spectroscopy, photochemistry, electrochemistry, metal analysis and thermal analysis, which carry out quality control activities to support the industrial sector (pharmaceutical, veterinary, active ingredients, biotechnology, etc.).
- Development, validation and transfer of analytical analysis
- Batch analysis for quality control
- Identification and quantification of impurities
- Quantification of active ingredients
- Determination of residual solvents
- Determination of ethylene oxide and dioxane residues
- Determination of elemental impurities or trace metals
- Identification and quantification of nitrosamines
- Analysis by DSC, TGA, IR, NMR, KF
IQS has the certificate of compliance with Good Manufacturing Practices, established in Directive 2003/94/EC, Directive 91/412/EC, which is issued by the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).
Analysis of nitrosamines, nitrites, and nitrates in drugs