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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

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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