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Analytical Development
Intelligent Management
All the developmental activities carried out at Getz Pharma Research are managed and conducted intelligently, scientifically and methodically to offer you the best service and on time.
Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug products to meet the standard of potency, purity and stability. Analytical chemists will work to develop, qualify and validate methods or refine existing analytical methods to meet these demands. Getz Pharma Research offers most
Pre-formulation & Formulationmodes of detection including UV/VIS, PDA, RI, Fluorescence and Conductivity detection, and has developed particular expertise that can address compounds that lack a UV chromophore. This is especially important in identifying impurities and degradation products and thus explaining the mass balance on stability.
- Analytical services
- Methods development and validation
- Identification, quantification, potency assessment, content uniformity
- Process contaminants, excipients, impurities, degradants
- Lot release and stability assessment
Getz Pharma Research performs release and stability testing for all types of drug products that are developed in-house. Appropriate sampling strategies are determined, documented and executed with utmost care.
Analytical services supporting stability programs include:
- Long-term stability testing
- Accelerated stability testing
- Photostability testing
- Comparative stability testing versus innovator product
- Forced degradation studies