Served Segments
We operate in multiple industrial sectors, providing comprehensive and reliable analytical solutions:
Pharmaceutical and biotechnological industries.
Manufacturers of APIs and chemical intermediates.
Cosmetics and dermocosmetics.
Sanitizing and household cleaning products.
Food and nutraceuticals.
Hospitals, clinics, and hemodialysis centers.
Microbiological Testing
Total viable aerobic microorganism count (bacteria and fungi).
Pathogen screening: Pseudomonas aeruginosa, Salmonella enterica, Candida albicans, Aspergillus brasiliensis, Bacillus spizizenii, Clostridium perfringens, Clostridium sporogenes, Enterococcus faecalis, Escherichia coli, Staphylococcus aureus.
Sterility and bacterial endotoxin testing (LAL test).
Antimicrobial efficacy testing (Challenge Test) and preservative efficacy testing.
Microbiological monitoring of cleanrooms (ISO class 5–8).
Validation of surface and equipment cleaning.
Bioburden testing and qualification of filtration and sanitization systems.
Physicochemical Testing
APIs, Pharmaceuticals, Food, Cosmetics, Water, and Related Products:
Quantification and qualification of substances.
Determination of physicochemical parameters: pH, density, viscosity, conductivity.
Moisture and water content – Karl Fischer.
Dissolution, disintegration, friability, hardness, and content uniformity testing.
Short- and long-term stability testing under controlled conditions.
Development and validation of analytical methodologies according to RDC 166/2017.
Physicochemical characterization of purified, potable, and industrial waters.
Nitrosamine Analysis
Mutagenic Impurity Control:
Screening and quantification of known and potential nitrosamines (NDMA, NDEA, NMBA, NDIPA, NEIPA, NDBA, etc.).
Highly sensitive LC-MS/MS chromatographic methods (LLOQ ≤ 10 ppb).
Development and validation of matrix-specific methods.
Risk assessment for nitrosamine formation according to ICH M7(R2) and RDC 677/2022.
Confirmatory testing and forced degradation studies.
Water and Effluent Analysis
- Potability Analysis: Apparent Color, Turbidity, pH, Free Chlorine, Fluoride, Conductivity, Total Dissolved Solids, Nitrate, Nitrite, Ammonia, Iron, Manganese, Aluminum, Chloride, Sulfate, and Total Hardness. Total Coliform and Escherichia coli Count.
- Autoclave Water Analysis: Appearance, Cadmium, Lead, Chlorides, Iron, Phosphate, Heavy Metal Residues. Silicon, pH, Temperature, Hardness, and Dry Residue.
- Purified Water Analysis: Conductivity, pH, Total Organic Carbon (TOC), Nitrate, Chloride, Sulfate, Ammonia, Calcium and Magnesium, Sodium and Potassium, Heavy Metals (when applicable).
- Total Microbial Count and Escherichia coli Survey.
- Hemodialysis Water Analysis: Conductivity, pH, Aluminum, Chloride, Sulfate, Calcium, Magnesium, Sodium, Potassium, Copper, Zinc, Nitrate, Fluoride, and Total Hardness. Bacterial Endotoxin Screening, Total Microbial Count, and Escherichia coli Screening.
- Ultrapure Water Analysis: Conductivity, Resistivity, Total Organic Carbon (TOC), pH, Sodium, Potassium, Calcium, Magnesium, Chloride, Sulfate, Silica, and Suspended Particles. Total Microbial Count and Bacterial Endotoxin Testing.
- Analysis of water for injectables: Conductivity, Total Organic Carbon (TOC), pH, Aluminum, Chloride, Sulfate, Ammonia, Nitrate, Heavy Metals (when applicable). Total Microbial Count and Bacterial Endotoxin Testing.
Analytical Method Validation and Development
Planning and execution according to ICH Q2(R2) and RDC 166/2017.
Studies of linearity, precision, accuracy, robustness, LOD, LOQ, and selectivity.
Development of novel methodologies and analytical transfer.
Stability and chemical compatibility studies.
Excellence Differentiators – Magnalab
State-of-the-art equipment (UPLC Waters, LC-MS/MS Waters, Karl Fischer, FTIR Thermo Fisher, Shimadzu).
Full traceability and data integrity (21 CFR Part 11).
Compliance with ISO/IEC 17025.
Bilingual reports (PT/EN), serving both national and international clients.
Regulatory Consulting and Technical Support
Specialized regulatory consulting with ANVISA.
Technical reports and Certificates of Analysis (CoA).
Support for regulatory dossiers, CADIFA, post-registration, and ANVISA petitions.
Internal and external audits, implementation of GLP and GMP.
Corporate training and quality risk management advisory (ICH Q9).
Product registration and notification hosting.
Technical reports for regulatory submission (ANVISA, EMA, FDA).
Ongoing Projects
- MAPA Certification (Ministry of Agriculture and Livestock)
- REBLAS Certification
- ISO 5 Cleanroom