Refractive index (RI) is used by a variety of industries to determine the level of solids in liquids. CD Formulation provides this important but relatively new measurement service in the development and manufacture of bulk drug substances (APIs) at the laboratory level, the small-scale pilot plant level, and at the industrial level in pharmaceutical manufacturing plants. Refractive index is a tool used in process analytical technology (PAT) to provide sufficient process understanding to aid in the design, analysis and control of pharmaceutical processes. There is a number of basic requirements to make a measurement technique suitable for a pharmaceutical process. First, the measurements should be accurate, reliable and easily scalable. The techniques and equipment used must be identical and provide reproducible data that can be made more readily available for process validation at the laboratory, pilot, or full scale. Second, data authenticity should be protected, with all measurements stored electronically and permanently, and any additions or changes can be tracked and attributed. Finally, traceable evidence of calibration should be available, as well as regular, documented performance verification.
Fig.1 An instrument for measuring refractive index.
All solutions have a specific refractive index value that will change as the reaction continues. This means that refractive index monitoring can provide an inside view of the reaction and extraction process as well as the chemically active components. Therefore, changes in refractive index can be used to track the progress of the reaction as well as to determine the end point.
Specific services that CD Formulation can bring to the table are:
Testing of refractive index.
Sample test data.
Provision of measurement technology solutions.
CD Formulation offers measurement solutions for applications in the pharmaceutical industry that is fully scalable, so that drug development and the process design can be seamlessly scaled up from the laboratory to full-scale mass production.
In general, refractive index monitoring can improve understanding of process conditions, reduce drug development time, increase yield and stability, improve product quality, and demonstrate regulatory compliance. Pharmaceutical manufacturers need to demonstrate process validation from drug discovery to volume production; this can be achieved through refractive index measurements, which provide unique process mapping that can be used for validation at any level.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.