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Progress was neither swift nor easy……

Case Studies

Tablet Content Uniformity
We have used a proven process to develop NIR assay methods for our clients for the determination of active pharmaceutical ingredient(s) in tablet dosage forms
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Process Validation
We have developed a proprietary multivariate modeling method that is named Supervised Principal Component Analysis (SPCA).........
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NIR in Formulation Development
NIR-SPCA method can also be used for speeding up the formulation development process.....
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PAT
Monitor blend uniformity in real time using our SPCA method to analyze the NIR blending data.
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Chemical Imaging
NIR chemical imaging as powerful tool to study the drug release mechanism of the matrix tablets......
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News Release

2010/2011 Press Releases and News

09/20/2012

Dr. Weiyong Li gave a speech at 10th International Pharmaceutical High Technology & Industrialization Development Summit: How is a Space technology used in Pharmaceutical Development.

07/07/2012

Niracle finish feasibility study to applying FTIR and NIR technology in quick indentifying recycle cooking oil.

02/12/2012

Niracle signed contract with a multi international healthcare company to develop new production QC method.

05/08/2011

Niracle signed contract with a leading pharmaceutical company to develop batch and tablet content uniformity models.

03/01/2011

Niracle LLC formed in Newtown, Pennsylvania.

12/15/2010

Dr. Weiyong Li gave a speech at EAS symposium, New Jersey. Evaluation of Drug Release from HPLC-Based Matrix Tablets by Near-Infrared Chemical Imaging.

03/15/2010

Nirvation landed a first major contract with a leading pharmaceutical company

12/03/22009

Nirvation, the predecessor of NiRACLE formed in Doylestown, Pennsylvania.

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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