About Apex Science
Apex Science is a company offering a differentiated and highly qualified service to companies that require analytical support in the techniques of liquid chromatography (LC), gas chromatography (GC), mass spectrometry (MS), and organic chemistry, with projects involving risk analysis, qualification, elucidation, synthesis, and characterization of impurities, in addition to solutions for nuclear magnetic resonance (NMR).
Using a scientific approach combined with state-of-the-art analytical instrumentation, Apex Science aims to provide its partners with high-quality solutions for their challenges, respecting deadlines and prioritizing transparency in its projects.
Industries We Serve
- Pharmaceutical
- Veterinary Pharmaceutical
- Medical Devices
- Cosmetics
Quality Policy
The laboratory operates in accordance with Good Laboratory Practice (GLP) to ensure sample traceability and that all analytical instruments are properly calibrated and qualified. The company also holds MAPA certification and is ANVISA-authorized with REBLAS. Additionally, it holds a physicochemical proficiency certificate from Controllab.
Technology Available
- Liquid chromatography
- Gas chromatography
- Mass spectrometry
- Nuclear magnetic resonance (NMR)
- Agilent 1290 UHPLC Systems
- Waters HPLC Systems
- Waters Xevo TQD UPLC-MS/MS System
- Waters Xevo TQ-S micro UPLC-MS/MS Systems
- Waters Xevo TQ Absolute UPLC-MS/MS Systems
- Thermo Q-Exactive UHPLC-HRMS Systems
- Thermo GC-FID/MS Systems
- Agilent GC-FID/MS System
- Thermo HS-GC-FID System
- Selekt Enkel Biotage System
- Complete setup for sample preparation
Overview of Solutions
Pharmaceutical
- Development and validation of methods and routine analyses
- Development of indicative stability methods
- Solubility studies
- Stability studies
- Dissolution
- Extractables and leachables
- Deformulation
- Analysis of nitrosamines and nitrites
- Analysis of nutraceuticals
- Preparation of critical analysis reports and risk analysis for nitrosamine formation
- Structural elucidation of unknown impurities
- Synthesis/isolation of impurities and degradation products
- Cleaning validation and routine analyses
- Characterization of standards
- Residual solvents
Veterinary Pharmaceutical
- Pharmacokinetic analyses in plasma
- Residue depletion studies in different matrices such as muscle, fat, kidney, liver, milk, etc.
Medical Devices
- Biological evaluation of medical devices according to ISO 10993
- Clinical evaluation of medical devices according to RDC 751/22
- Chemical characterization of medical devices according to ISO 10993
Cosmetics
- Determination of mutagenic and prohibited impurities
- Method development for raw materials and active ingredients: screening, content, benzene, 1,4-dioxane and other residual solvents, ester content, fat composition, impurity determination, comparative analyses, and quality control
- Characterization of raw materials, plant extracts, and waxes
- Investigative analyses: migration of dyes from packaging to product; formation of unexpected aspects
- Metabolomics: determination of seasonal effects and best conditions for obtaining active ingredients; evaluation of new extracts with identification of potential actives; phytochemical and oil profiling
- Isolation and synthesis of compounds
- Allergens according to RDC 530/21
