The Medinfar Laboratory has an analytical laboratory, with a Good Manufacturing Practices (GMP) certificate, which allows for validations of analytical methods, physical-chemical analysis in sterile and non-sterile products and microbiological analysis in non-sterile products. All this being developed by considering regulatory and quality requirements. Hence, we are able to meet different national and international market requirements.
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS
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- Development and validation of analytical methods for Dosing and Identification of APIs, preservatives, anti-oxidants (by Potentiometric titration, Spectrophotometry or HPLC) and Vitamins by HPLC
- Development and validation of analytical methods for Dissolution and gastro-resistance testing (by UV and HPLC)
- Development and validation of analytical methods for the determination of HPLC related substances
- Development of methods for Viscosity Measurement
- API vs Excipient Compatibilities
- API solubility determination
- Forced Degradation Tests
- Development and validation of measurement methods for particle size distribution in APIs
- Validation of laboratory material cleaning procedures
QUALITY CONTROL AND STABILITY STUDIES
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- Finished Product Analysis
- Stability studies in all climate zones (ICH, Ongoing, In Use/PaO)
- Holding Time Studies
- Photo Stability Testing
- Freeze Thaw Studies
- Analytical Transfer
- Comparative dissolution tests (PA/API) In Vitro
- In Vitro permeation tests
MICROBIOLOGY LAB
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- Microbiological Control in non-necessarily sterile Medicines and Supplements
- Microbiological Control in Cosmetics, Body Care Products and Veterinary Products according to ISO Benchmarks
- Evaluation of the Effectiveness of Preservatives
- Microbiological testing of MIC and dosing of Active Ingredients
- Development and validation of microbiological methods
- Identification of microbial contaminants
- Qualification of disinfectants and cleaning validation studies
- Performance of Growth-promoting, inhibitory and indicative properties tests
- Water and environmental control