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Case Studies
NiRACLE’s clients include large and middle sized pharmaceutical companies as well as the world’s leading food companies. We are a small company, but we play a pivotal role in our clients’ overall development projects by providing method development support, product development/scale-up support, and product/process trouble-shooting support with sophisticated methodologies and data analysis tools.
Business Opportunity – New generation of analytical method that is fast, non-destructive, cost-effective and GMP compliant.
Technology – Transmission NIR with Multivariate Calibration Modeling
Case Study 1 : Near Infrared Assay Method for Tablet Content Uniformity
Case Study 2 : Near Infrared Method for Process Validation
Business Opportunity – Process monitoring method that can ensure a smooth transition from pharmaceutical R&D to commercial manufacturing.
Technology – NIR and Supervised Principal Component Analysis
Case Study 3 : Near Infrared Method in Early-Stage Formulation Development
Business Opportunity – NIR-SPCA method that can speed up early stage formulation development.
Technology – NIR and Supervised Principal Component Analysis
Case Study 4 : PAT Method for Real Time Process Monitoring and Control
Business Opportunity – State-of-the-art PAT method that can be used for monitoring pharmaceutical manufacturing unit operations such as powder blending and tablet coating.
Technology – NIR/Raman Probe
Case Study 5 : Near Infrared Chemical Imaging for Studying Matrix Tablet Drug Release
Business Opportunity –Sophisticated chemical imaging method that ensures safety and efficacy of a popular category of drug products
Technology – Near Infrared Chemical Imaging
Case Study 6 : NIR Chemical Imaging in Pharmaceutical Product Troubleshooting
Business Opportunity – NIR Chemical imaging method that can be used in root cause analysis of out-of-specification pharmaceutical products
Technology – NIR chemical imaging
Our services
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| Method Development | Process Validation | Troubleshooting | Material Identification | User Training | |||||
| NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and designing a comprehensive sampling plan. | NiRACLE is specialized in multivariate data analysis, which plays a critical role in today’s process validation.NiRACLE works with clients in selecting suitable process monitoring methods and designing a comprehensive sampling plan. | Using NIR chemical imaging and multivariate data analysis tools, NiRACLE can assist clients in troubleshooting product and process related problems. | NiRACLE can help clients in developing a NIR-based raw material identification system to replace the conventional wet chemistry methods. | NiRACLE provides training in basic and advanced NIR/NIR chemical imaging related method development, which include proper use of instruments, experiment design and multivation... | |||||
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